Trial Outcomes & Findings for Safety, Tolerability and Pharmacokinetics of an Anti-PD-1 Monoclonal Antibody in Subjects With Advanced Malignancies (NCT NCT03474640)

NCT ID: NCT03474640

Last Updated: 2024-11-22

Results Overview

To assess the number of treatment-related adverse events in the toripalimab arm as assessed by CTCAE v4.0

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

184 participants

Primary outcome timeframe

Through study completion, an estimated period of approximately 2 years.

Results posted on

2024-11-22

Participant Flow

This study was initiated on 21 February 2018 (first patient signed the informed consent form) and completed on 07 June 2022. This study was conducted and screened patients in 14 sites in the United States.

Once a patient was determined to be eligible, the patient was considered "enrolled" and an identification number was to be assigned, which denoted the dose-level or disease-specific cohort assignment. Patients who failed to meet the inclusion/exclusion criteria (i.e., screen failures) might be rescreened up to 3 times and would maintain their same screening number. Study participation began once a patient received the first dose of toripalimab.

Participant milestones

Participant milestones
Measure	Toripalimab 80 mg Repeat Dose Every 14 Days 3-6 subjects (Part A) Toripalimab 80 mg repeat dose every 14 days	Toripalimab 240 mg Repeat Dose Every 14 Days 3-6 subjects (Part A) Toripalimab 240 mg repeat dose every 14 days	Toripalimab 480 mg Repeat Dose Every 14 Days 3-6 subjects (Part A) Toripalimab 480 mg repeat dose every 14 days	Biliary Tract Cancer Toripalimab 240 mg IV every 3 weeks 42 patients	Sarcoma Toripalimab 240 mg IV every 3 weeks 59 patients	Esophageal Cancer Toripalimab 240 mg IV every 3 weeks 11 patients	Gastric Cancer Toripalimab 240 mg IV every 3 weeks 29 patients	Neuroendocrine Cancer Toripalimab 240 mg IV every 3 weeks 22 patients	Other Tumors Toripalimab 240 mg IV every 3 weeks 3 patients
Overall Study STARTED	3	8	7	42	59	11	29	22	3
Overall Study COMPLETED	0	0	2	8	7	1	3	6	1
Overall Study NOT COMPLETED	3	8	5	34	52	10	26	16	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety, Tolerability and Pharmacokinetics of an Anti-PD-1 Monoclonal Antibody in Subjects With Advanced Malignancies

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Part A: Toripalimab 80 mg Every 14 Days n=3 Participants 3-6 subjects (Part A) Patients with relapsed or refractory solid tumors who have progressed on standard treatment	Part A: Toripalimab 240 mg Every 14 Days n=8 Participants 3-6 subjects (Part A) Patients with relapsed or refractory solid tumors who have progressed on standard treatment	Part A: Toripalimab 480 mg Every 14 Days n=7 Participants 3-6 subjects (Part A) Patients with relapsed or refractory solid tumors who have progressed on standard treatment	Part B: Sarcoma n=59 Participants 44-80 subjects (Part B) soft tissue sarcoma (excluding leiomyosarcoma) or chondrosarcoma who have progressed on at least one prior regimen for metastatic disease Toripalimab, 240 mg IV every 21 days	Part B: Other Tumors n=3 Participants 22-40 subjects (Part B) nasopharyngeal cancer (NPC), hepatocellular cancer (HCC),MSI-H/dMMR who have progressed on at least one prior regimen for metastatic disease Toripalimab, 240 mg IV every 21 days	Part B: Esophogeal n=11 Participants 22-40 subjects (Part B) esophogeal cancer who have progressed on at least one prior regimen for metastatic disease Toripalimab, 240 mg IV every 21 days	Part B: Gastric/GEJ n=29 Participants 22-40 subjects (Part B) gastric/GEJ cancer who have progressed on at least one prior regimen for metastatic disease Toripalimab, 240 mg IV every 21 days	Part B: Biliary Tract n=42 Participants 22-40 subjects (Part B) biliary tract cancer who have progressed on at least one prior regimen for metastatic disease Toripalimab, 240 mg IV every 21 day	Part B: Neuroendocrine n=22 Participants 22-40 subjects (Part B) neuroendocrine cancer who have progressed on at least one prior regimen for metastatic disease Toripalimab, 240 mg IV every 21 day	Total n=184 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants	0 Participants n=31 Participants	0 Participants n=146 Participants	0 Participants n=19 Participants	0 Participants n=147 Participants	0 Participants n=193 Participants	0 Participants	0 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=39 Participants	6 Participants n=41 Participants	5 Participants n=35 Participants	37 Participants n=31 Participants	2 Participants n=146 Participants	6 Participants n=19 Participants	11 Participants n=147 Participants	25 Participants n=193 Participants	9 Participants	103 Participants
Age, Categorical >=65 years	1 Participants n=39 Participants	2 Participants n=41 Participants	2 Participants n=35 Participants	22 Participants n=31 Participants	1 Participants n=146 Participants	5 Participants n=19 Participants	18 Participants n=147 Participants	17 Participants n=193 Participants	13 Participants	81 Participants
Age, Continuous	62 years n=39 Participants	60.5 years n=41 Participants	55 years n=35 Participants	60 years n=31 Participants	40 years n=146 Participants	63 years n=19 Participants	66 years n=147 Participants	60.5 years n=193 Participants	65.5 years	62 years
Sex: Female, Male Female	1 Participants n=39 Participants	5 Participants n=41 Participants	5 Participants n=35 Participants	26 Participants n=31 Participants	1 Participants n=146 Participants	2 Participants n=19 Participants	8 Participants n=147 Participants	28 Participants n=193 Participants	4 Participants	80 Participants
Sex: Female, Male Male	2 Participants n=39 Participants	3 Participants n=41 Participants	2 Participants n=35 Participants	33 Participants n=31 Participants	2 Participants n=146 Participants	9 Participants n=19 Participants	21 Participants n=147 Participants	14 Participants n=193 Participants	18 Participants	104 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=39 Participants	1 Participants n=41 Participants	0 Participants n=35 Participants	7 Participants n=31 Participants	2 Participants n=146 Participants	1 Participants n=19 Participants	1 Participants n=147 Participants	1 Participants n=193 Participants	1 Participants	14 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=39 Participants	7 Participants n=41 Participants	7 Participants n=35 Participants	49 Participants n=31 Participants	1 Participants n=146 Participants	9 Participants n=19 Participants	28 Participants n=147 Participants	40 Participants n=193 Participants	20 Participants	164 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants	3 Participants n=31 Participants	0 Participants n=146 Participants	1 Participants n=19 Participants	0 Participants n=147 Participants	1 Participants n=193 Participants	1 Participants	6 Participants
Region of Enrollment United States	3 Participants n=39 Participants	8 Participants n=41 Participants	7 Participants n=35 Participants	59 Participants n=31 Participants	3 Participants n=146 Participants	11 Participants n=19 Participants	29 Participants n=147 Participants	42 Participants n=193 Participants	22 Participants	184 Participants

PRIMARY outcome

Timeframe: Through study completion, an estimated period of approximately 2 years.

To assess the number of treatment-related adverse events in the toripalimab arm as assessed by CTCAE v4.0

Outcome measures

Outcome measures
Measure	Part A: 80 mg n=3 Participants Part A 80 mg IV toripalimab every 14 days Sequential dose escalation (3+3)	Part A: 240 mg n=8 Participants Part A 240 mg IV toripalimab every 14 days Sequential dose escalation (3+3)	Part A: 480 mg n=7 Participants Part A 480 mg IV toripalimab every 14 days Sequential dose escalation (3+3)	Part B: Sarcoma n=59 Participants 44-80 subjects (Part B) soft tissue sarcoma (excluding leiomyosarcoma or chondrosarcoma) who have progressed on at least one prior therapy regimen for metastatic disease. Toripalimab 240 mg IV every 21 days.	Part B: Other Tumors n=3 Participants 22-40 subjects (Part B)nasopharyngeal cancer (NPC), hepatocellular cancer (HCC),MSI-H/dMMR who have progressed on at least one prior regimen for metastatic disease. Toripalimab 240 mg IV every 21 days.	Part B: Esophageal n=11 Participants 22-40 subjects (PartB) esophogeal cancer who have progressed on at least one prior regimen for metastatic disease. Toripalimab 240 mg IV every 21days.	Part B: Gastric/GEJ n=29 Participants 22-40 subjects (PartB) gastric/GEJ cancer who have progressed on at least one prior regimen for metastatic disease. Toripalimab,240 mg IV every 21days.	Part B: Biliary Tract n=42 Participants 22-40 subjects (PartB) biliary tract cancer who have progressed on at least one prior regimen for metastatic disease. Toripalimab,240 mg IV every 21 days.	Part B: Neuroendocrine n=22 Participants 22-40 subjects (Part B)neuroendocrine cancer who have progressed on at least one prior regimen for metastatic disease. Toripalimab 240 mg IV every 21 days.
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0	2 Participants	5 Participants	5 Participants	33 Participants	2 Participants	7 Participants	15 Participants	27 Participants	14 Participants

SECONDARY outcome

Timeframe: Every 8 weeks (Part A) or every 9 weeks (Part B) through study completion, an estimated duration of 2 years.

The treatment effect of Toripalimab was assessed using RECIST 1.1 to determine objective response rate. ORR was defined and analyzed as the number of subjects achieving BOR of CR or PR, divided by the number of treated subjects. Subjects without at least one post-baseline radiological assessment were treated as non-responders. ORR was presented by dose cohort in Part A and tumor type in Part B, with 95% confidence intervals.

Outcome measures

Outcome measures
Measure	Part A: 80 mg n=3 Participants Part A 80 mg IV toripalimab every 14 days Sequential dose escalation (3+3)	Part A: 240 mg n=8 Participants Part A 240 mg IV toripalimab every 14 days Sequential dose escalation (3+3)	Part A: 480 mg n=7 Participants Part A 480 mg IV toripalimab every 14 days Sequential dose escalation (3+3)	Part B: Sarcoma n=59 Participants 44-80 subjects (Part B) soft tissue sarcoma (excluding leiomyosarcoma or chondrosarcoma) who have progressed on at least one prior therapy regimen for metastatic disease. Toripalimab 240 mg IV every 21 days.	Part B: Other Tumors n=3 Participants 22-40 subjects (Part B)nasopharyngeal cancer (NPC), hepatocellular cancer (HCC),MSI-H/dMMR who have progressed on at least one prior regimen for metastatic disease. Toripalimab 240 mg IV every 21 days.	Part B: Esophageal n=11 Participants 22-40 subjects (PartB) esophogeal cancer who have progressed on at least one prior regimen for metastatic disease. Toripalimab 240 mg IV every 21days.	Part B: Gastric/GEJ n=29 Participants 22-40 subjects (PartB) gastric/GEJ cancer who have progressed on at least one prior regimen for metastatic disease. Toripalimab,240 mg IV every 21days.	Part B: Biliary Tract n=42 Participants 22-40 subjects (PartB) biliary tract cancer who have progressed on at least one prior regimen for metastatic disease. Toripalimab,240 mg IV every 21 days.	Part B: Neuroendocrine n=22 Participants 22-40 subjects (Part B)neuroendocrine cancer who have progressed on at least one prior regimen for metastatic disease. Toripalimab 240 mg IV every 21 days.
Objective Response Rate (ORR)	0 Participants	0 Participants	0 Participants	5 Participants	0 Participants	3 Participants	1 Participants	2 Participants	3 Participants

SECONDARY outcome

Timeframe: Every 8 weeks (Part A) or every 9 weeks (Part B) through study completion, an estimated duration of 2 years.

The treatment effect of Toripalimab was assessed using RECIST 1.1 to determine objective response rate. ORR was defined and analyzed as the number of subjects achieving BOR of CR, PR, or SD divided by the number of treated subjects. Subjects without at least one post-baseline radiological assessment were treated as non-responders. DCR was presented by dose cohort in Part A and tumor type in Part B, with 95% confidence intervals.

Outcome measures

Outcome measures
Measure	Part A: 80 mg n=3 Participants Part A 80 mg IV toripalimab every 14 days Sequential dose escalation (3+3)	Part A: 240 mg n=8 Participants Part A 240 mg IV toripalimab every 14 days Sequential dose escalation (3+3)	Part A: 480 mg n=7 Participants Part A 480 mg IV toripalimab every 14 days Sequential dose escalation (3+3)	Part B: Sarcoma n=59 Participants 44-80 subjects (Part B) soft tissue sarcoma (excluding leiomyosarcoma or chondrosarcoma) who have progressed on at least one prior therapy regimen for metastatic disease. Toripalimab 240 mg IV every 21 days.	Part B: Other Tumors n=3 Participants 22-40 subjects (Part B)nasopharyngeal cancer (NPC), hepatocellular cancer (HCC),MSI-H/dMMR who have progressed on at least one prior regimen for metastatic disease. Toripalimab 240 mg IV every 21 days.	Part B: Esophageal n=11 Participants 22-40 subjects (PartB) esophogeal cancer who have progressed on at least one prior regimen for metastatic disease. Toripalimab 240 mg IV every 21days.	Part B: Gastric/GEJ n=29 Participants 22-40 subjects (PartB) gastric/GEJ cancer who have progressed on at least one prior regimen for metastatic disease. Toripalimab,240 mg IV every 21days.	Part B: Biliary Tract n=42 Participants 22-40 subjects (PartB) biliary tract cancer who have progressed on at least one prior regimen for metastatic disease. Toripalimab,240 mg IV every 21 days.	Part B: Neuroendocrine n=22 Participants 22-40 subjects (Part B)neuroendocrine cancer who have progressed on at least one prior regimen for metastatic disease. Toripalimab 240 mg IV every 21 days.
Disease Control Rate (DCR)	0 Participants	5 Participants	6 Participants	25 Participants	1 Participants	4 Participants	7 Participants	17 Participants	11 Participants

SECONDARY outcome

Timeframe: Every 8 weeks (Part A) or every 9 weeks (Part B) through study completion, an estimated duration of 2 years.

The treatment effect of Toripalimab was assessed using RECIST 1.1 to determine progression-free survival time. PFS was defined as the time from the first dose of toripalimab to the first PD or death due to any cause, whichever occurred first and was analyzed separately for each cohort in Part B only,

Outcome measures

Outcome measures
Measure	Part A: 80 mg n=59 Participants Part A 80 mg IV toripalimab every 14 days Sequential dose escalation (3+3)	Part A: 240 mg n=3 Participants Part A 240 mg IV toripalimab every 14 days Sequential dose escalation (3+3)	Part A: 480 mg n=11 Participants Part A 480 mg IV toripalimab every 14 days Sequential dose escalation (3+3)	Part B: Sarcoma n=29 Participants 44-80 subjects (Part B) soft tissue sarcoma (excluding leiomyosarcoma or chondrosarcoma) who have progressed on at least one prior therapy regimen for metastatic disease. Toripalimab 240 mg IV every 21 days.	Part B: Other Tumors n=42 Participants 22-40 subjects (Part B)nasopharyngeal cancer (NPC), hepatocellular cancer (HCC),MSI-H/dMMR who have progressed on at least one prior regimen for metastatic disease. Toripalimab 240 mg IV every 21 days.	Part B: Esophageal n=22 Participants 22-40 subjects (PartB) esophogeal cancer who have progressed on at least one prior regimen for metastatic disease. Toripalimab 240 mg IV every 21days.	Part B: Gastric/GEJ 22-40 subjects (PartB) gastric/GEJ cancer who have progressed on at least one prior regimen for metastatic disease. Toripalimab,240 mg IV every 21days.	Part B: Biliary Tract 22-40 subjects (PartB) biliary tract cancer who have progressed on at least one prior regimen for metastatic disease. Toripalimab,240 mg IV every 21 days.	Part B: Neuroendocrine 22-40 subjects (Part B)neuroendocrine cancer who have progressed on at least one prior regimen for metastatic disease. Toripalimab 240 mg IV every 21 days.
Progression-Free Survival (PFS)	2.2 months Interval 1.8 to 6.2	1.4 months Interval 1.0 to 4.1	2.1 months Interval 2.1 to 6.2	2.1 months Interval 1.5 to 4.0	2.1 months Interval 1.8 to 4.1	6.4 months Interval 1.5 to NA, N.E.= Not Estimable, insufficient number of patients with events	—	—	—

SECONDARY outcome

Timeframe: Through study completion, an estimated duration of 2 years.

The treatment effect of Toripalimab was assessed using RECIST 1.1 to determine overall survival (OS) analysis by tumor type in Part B. OS was defined as the time from date the first dose of toripalimab until death due to any cause. OS time for subjects not achieving the endpoint was censored at the last known alive date.

Outcome measures

Outcome measures
Measure	Part A: 80 mg n=59 Participants Part A 80 mg IV toripalimab every 14 days Sequential dose escalation (3+3)	Part A: 240 mg n=3 Participants Part A 240 mg IV toripalimab every 14 days Sequential dose escalation (3+3)	Part A: 480 mg n=11 Participants Part A 480 mg IV toripalimab every 14 days Sequential dose escalation (3+3)	Part B: Sarcoma n=29 Participants 44-80 subjects (Part B) soft tissue sarcoma (excluding leiomyosarcoma or chondrosarcoma) who have progressed on at least one prior therapy regimen for metastatic disease. Toripalimab 240 mg IV every 21 days.	Part B: Other Tumors n=42 Participants 22-40 subjects (Part B)nasopharyngeal cancer (NPC), hepatocellular cancer (HCC),MSI-H/dMMR who have progressed on at least one prior regimen for metastatic disease. Toripalimab 240 mg IV every 21 days.	Part B: Esophageal n=22 Participants 22-40 subjects (PartB) esophogeal cancer who have progressed on at least one prior regimen for metastatic disease. Toripalimab 240 mg IV every 21days.	Part B: Gastric/GEJ 22-40 subjects (PartB) gastric/GEJ cancer who have progressed on at least one prior regimen for metastatic disease. Toripalimab,240 mg IV every 21days.	Part B: Biliary Tract 22-40 subjects (PartB) biliary tract cancer who have progressed on at least one prior regimen for metastatic disease. Toripalimab,240 mg IV every 21 days.	Part B: Neuroendocrine 22-40 subjects (Part B)neuroendocrine cancer who have progressed on at least one prior regimen for metastatic disease. Toripalimab 240 mg IV every 21 days.
Overall Survival (OS)	4.9 months Interval 3.71 to 6.54	1.4 months Interval 1.12 to NA, N.E.= Not Estimable, insufficient number of patients with events	5.7 months Interval 0.79 to 21.72	3.5 months Interval 2.33 to 6.93	4.4 months Interval 3.48 to 4.86	4.2 months Interval 2.6 to 8.25	—	—	—

Adverse Events

Toripalimab 80 mg Every 14 Days

Serious events: 2 serious events

Other events: 2 other events

Deaths: 1 deaths

Toripalimab 240 mg Every 14 Days

Serious events: 2 serious events

Other events: 5 other events

Deaths: 2 deaths

Toripalimab 480 mg Every 14 Days

Serious events: 4 serious events

Other events: 5 other events

Deaths: 0 deaths

Sarcoma

Serious events: 23 serious events

Other events: 33 other events

Deaths: 12 deaths

Other Tumors

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Esophogeal

Serious events: 3 serious events

Other events: 7 other events

Deaths: 2 deaths

Gastric/GEJ

Serious events: 11 serious events

Other events: 15 other events

Deaths: 9 deaths

Biliary Tract

Serious events: 23 serious events

Other events: 27 other events

Deaths: 12 deaths

Neuroendocrine

Serious events: 6 serious events

Other events: 14 other events

Deaths: 3 deaths

Serious adverse events

Serious adverse events
Measure	Toripalimab 80 mg Every 14 Days n=3 participants at risk 3-6 subjects (Part A) Patients with relapsed or refractory solid tumors who have progressed on standard treatment	Toripalimab 240 mg Every 14 Days n=8 participants at risk 3-6 subjects (Part A) Patients with relapsed or refractory solid tumors who have progressed on standard treatment	Toripalimab 480 mg Every 14 Days n=7 participants at risk 3-6 subjects (Part A) Patients with relapsed or refractory solid tumors who have progressed on standard treatment	Sarcoma n=59 participants at risk 44-80 subjects (Part B) soft tissue sarcoma (excluding leiomyosarcoma) or chondrosarcoma who have progressed on at least one prior regimen for metastatic disease Toripalimab, 240 mg IV every 21 days	Other Tumors n=3 participants at risk 22-40 subjects (Part B) nasopharyngeal cancer (NPC), hepatocellular cancer (HCC),MSI-H/dMMR who have progressed on at least one prior regimen for metastatic disease Toripalimab, 240 mg IV every 21 days	Esophogeal n=11 participants at risk 22-40 subjects (Part B) esophogeal cancer who have progressed on at least one prior regimen for metastatic disease Toripalimab, 240 mg IV every 21 days	Gastric/GEJ n=29 participants at risk 22-40 subjects (Part B) gastric/GEJ cancer who have progressed on at least one prior regimen for metastatic disease Toripalimab, 240 mg IV every 21 days	Biliary Tract n=42 participants at risk 22-40 subjects (Part B) biliary tract cancer who have progressed on at least one prior regimen for metastatic disease Toripalimab, 240 mg IV every 21 day	Neuroendocrine n=22 participants at risk 22-40 subjects (Part B) neuroendocrine cancer who have progressed on at least one prior regimen for metastatic disease Toripalimab, 240 mg IV every 21 day
Gastrointestinal disorders Gastrointestinal Disorders	0.00% 0/3 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	0.00% 0/8 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	14.3% 1/7 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	1.7% 1/59 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	0.00% 0/3 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	9.1% 1/11 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	20.7% 6/29 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	11.9% 5/42 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	4.5% 1/22 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.
Infections and infestations Infections and Infestations	0.00% 0/3 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	0.00% 0/8 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	14.3% 1/7 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	6.8% 4/59 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	0.00% 0/3 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	18.2% 2/11 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	3.4% 1/29 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	19.0% 8/42 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	0.00% 0/22 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders	33.3% 1/3 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	0.00% 0/8 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	0.00% 0/7 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	11.9% 7/59 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	0.00% 0/3 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	0.00% 0/11 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	17.2% 5/29 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	4.8% 2/42 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	0.00% 0/22 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.
Metabolism and nutrition disorders Metabolism and Nutrition Disorders	0.00% 0/3 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	0.00% 0/8 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	14.3% 1/7 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	5.1% 3/59 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	33.3% 1/3 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	0.00% 0/11 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	6.9% 2/29 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	2.4% 1/42 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	9.1% 2/22 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.
Nervous system disorders Nervous System Disorders	33.3% 1/3 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	0.00% 0/8 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	0.00% 0/7 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	5.1% 3/59 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	0.00% 0/3 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	0.00% 0/11 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	0.00% 0/29 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	0.00% 0/42 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	0.00% 0/22 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.
Musculoskeletal and connective tissue disorders Musculoskeletal and Connective Tissue Disorders	0.00% 0/3 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	12.5% 1/8 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	0.00% 0/7 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	0.00% 0/59 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	0.00% 0/3 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	0.00% 0/11 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	0.00% 0/29 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	0.00% 0/42 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	0.00% 0/22 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.
Reproductive system and breast disorders Reproductive System and Breast Disorders	0.00% 0/3 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	12.5% 1/8 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	0.00% 0/7 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	0.00% 0/59 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	0.00% 0/3 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	0.00% 0/11 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	0.00% 0/29 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	0.00% 0/42 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	0.00% 0/22 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.
Renal and urinary disorders Renal and Urinary Disorders	0.00% 0/3 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	0.00% 0/8 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	14.3% 1/7 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	1.7% 1/59 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	0.00% 0/3 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	0.00% 0/11 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	0.00% 0/29 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	7.1% 3/42 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	4.5% 1/22 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.
General disorders General Disorders	0.00% 0/3 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	0.00% 0/8 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	0.00% 0/7 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	5.1% 3/59 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	0.00% 0/3 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	0.00% 0/11 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	3.4% 1/29 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	2.4% 1/42 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	9.1% 2/22 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.
Vascular disorders Vascular Disorders	0.00% 0/3 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	0.00% 0/8 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	0.00% 0/7 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	5.1% 3/59 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	0.00% 0/3 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	0.00% 0/11 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	0.00% 0/29 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	0.00% 0/42 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	0.00% 0/22 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.
Hepatobiliary disorders Hepatobiliary Disorders	0.00% 0/3 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	0.00% 0/8 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	0.00% 0/7 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	0.00% 0/59 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	0.00% 0/3 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	0.00% 0/11 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	0.00% 0/29 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	2.4% 1/42 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	4.5% 1/22 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.
Injury, poisoning and procedural complications Injury, Poisoning and Procedural Complications	0.00% 0/3 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	0.00% 0/8 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	0.00% 0/7 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	1.7% 1/59 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	0.00% 0/3 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	0.00% 0/11 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	0.00% 0/29 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	4.8% 2/42 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	4.5% 1/22 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.
Blood and lymphatic system disorders Blood and Lymphatic System Disorders	0.00% 0/3 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	0.00% 0/8 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	0.00% 0/7 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	1.7% 1/59 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	0.00% 0/3 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	0.00% 0/11 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	0.00% 0/29 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	0.00% 0/42 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	0.00% 0/22 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.
Cardiac disorders Cardiac Disorders	0.00% 0/3 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	0.00% 0/8 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	0.00% 0/7 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	3.4% 2/59 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	0.00% 0/3 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	0.00% 0/11 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	0.00% 0/29 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	0.00% 0/42 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	0.00% 0/22 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.
Skin and subcutaneous tissue disorders Skin and Subcutaneous Disorders	0.00% 0/3 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	0.00% 0/8 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	0.00% 0/7 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	1.7% 1/59 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	0.00% 0/3 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	0.00% 0/11 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	0.00% 0/29 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	0.00% 0/42 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	4.5% 1/22 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.
Endocrine disorders Endocrine Disorders	0.00% 0/3 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	0.00% 0/8 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	0.00% 0/7 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	1.7% 1/59 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	0.00% 0/3 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	0.00% 0/11 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	0.00% 0/29 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	0.00% 0/42 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	0.00% 0/22 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.
Immune system disorders Immune System Disorders	0.00% 0/3 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	0.00% 0/8 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	0.00% 0/7 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	1.7% 1/59 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	0.00% 0/3 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	0.00% 0/11 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	0.00% 0/29 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	0.00% 0/42 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	0.00% 0/22 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.

Other adverse events

Other adverse events
Measure	Toripalimab 80 mg Every 14 Days n=3 participants at risk 3-6 subjects (Part A) Patients with relapsed or refractory solid tumors who have progressed on standard treatment	Toripalimab 240 mg Every 14 Days n=8 participants at risk 3-6 subjects (Part A) Patients with relapsed or refractory solid tumors who have progressed on standard treatment	Toripalimab 480 mg Every 14 Days n=7 participants at risk 3-6 subjects (Part A) Patients with relapsed or refractory solid tumors who have progressed on standard treatment	Sarcoma n=59 participants at risk 44-80 subjects (Part B) soft tissue sarcoma (excluding leiomyosarcoma) or chondrosarcoma who have progressed on at least one prior regimen for metastatic disease Toripalimab, 240 mg IV every 21 days	Other Tumors n=3 participants at risk 22-40 subjects (Part B) nasopharyngeal cancer (NPC), hepatocellular cancer (HCC),MSI-H/dMMR who have progressed on at least one prior regimen for metastatic disease Toripalimab, 240 mg IV every 21 days	Esophogeal n=11 participants at risk 22-40 subjects (Part B) esophogeal cancer who have progressed on at least one prior regimen for metastatic disease Toripalimab, 240 mg IV every 21 days	Gastric/GEJ n=29 participants at risk 22-40 subjects (Part B) gastric/GEJ cancer who have progressed on at least one prior regimen for metastatic disease Toripalimab, 240 mg IV every 21 days	Biliary Tract n=42 participants at risk 22-40 subjects (Part B) biliary tract cancer who have progressed on at least one prior regimen for metastatic disease Toripalimab, 240 mg IV every 21 day	Neuroendocrine n=22 participants at risk 22-40 subjects (Part B) neuroendocrine cancer who have progressed on at least one prior regimen for metastatic disease Toripalimab, 240 mg IV every 21 day
Skin and subcutaneous tissue disorders Skin and Subcutaneous Disorder	0.00% 0/3 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	25.0% 2/8 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	28.6% 2/7 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	15.3% 9/59 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	66.7% 2/3 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	0.00% 0/11 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	20.7% 6/29 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	4.8% 2/42 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	22.7% 5/22 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.
Investigations Investigations	33.3% 1/3 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	0.00% 0/8 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	14.3% 1/7 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	20.3% 12/59 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	0.00% 0/3 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	27.3% 3/11 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	13.8% 4/29 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	28.6% 12/42 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	13.6% 3/22 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.
General disorders General Disorders	0.00% 0/3 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	25.0% 2/8 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	14.3% 1/7 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	16.9% 10/59 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	0.00% 0/3 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	27.3% 3/11 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	13.8% 4/29 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	26.2% 11/42 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	27.3% 6/22 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.
Metabolism and nutrition disorders Metabolism and nutrition disorders	0.00% 0/3 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	12.5% 1/8 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	14.3% 1/7 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	8.5% 5/59 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	0.00% 0/3 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	18.2% 2/11 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	13.8% 4/29 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	9.5% 4/42 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	9.1% 2/22 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.
Gastrointestinal disorders Gastrointestinal Disorders	0.00% 0/3 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	25.0% 2/8 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	14.3% 1/7 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	16.9% 10/59 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	0.00% 0/3 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	27.3% 3/11 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	13.8% 4/29 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	26.2% 11/42 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	18.2% 4/22 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.
Blood and lymphatic system disorders Blood and Lymphatic Disorders	33.3% 1/3 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	37.5% 3/8 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	14.3% 1/7 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	8.5% 5/59 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	0.00% 0/3 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	0.00% 0/11 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	6.9% 2/29 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	14.3% 6/42 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	4.5% 1/22 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.
Endocrine disorders Endocrine Disorders	0.00% 0/3 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	12.5% 1/8 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	0.00% 0/7 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	16.9% 10/59 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	33.3% 1/3 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	18.2% 2/11 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	3.4% 1/29 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	2.4% 1/42 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	9.1% 2/22 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.
Nervous system disorders Nervous System Disorders	33.3% 1/3 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	12.5% 1/8 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	0.00% 0/7 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	1.7% 1/59 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	0.00% 0/3 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	9.1% 1/11 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	17.2% 5/29 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	2.4% 1/42 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	0.00% 0/22 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.
Musculoskeletal and connective tissue disorders Musculoskeletal and Connective Tissue Disorders	0.00% 0/3 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	0.00% 0/8 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	0.00% 0/7 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	5.1% 3/59 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	0.00% 0/3 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	0.00% 0/11 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	0.00% 0/29 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	9.5% 4/42 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	4.5% 1/22 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.
Injury, poisoning and procedural complications Injury, Poisoning, and Procedural Complications	0.00% 0/3 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	0.00% 0/8 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	14.3% 1/7 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	1.7% 1/59 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	0.00% 0/3 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	0.00% 0/11 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	3.4% 1/29 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	0.00% 0/42 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	4.5% 1/22 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.
Cardiac disorders Cardiac Disorders	0.00% 0/3 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	0.00% 0/8 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	14.3% 1/7 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	0.00% 0/59 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	0.00% 0/3 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	0.00% 0/11 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	0.00% 0/29 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	0.00% 0/42 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	0.00% 0/22 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.
Vascular disorders Vascular Disorders	0.00% 0/3 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	0.00% 0/8 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	14.3% 1/7 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	5.1% 3/59 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	0.00% 0/3 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	0.00% 0/11 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	0.00% 0/29 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	0.00% 0/42 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	0.00% 0/22 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant, and unspecified	0.00% 0/3 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	0.00% 0/8 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	14.3% 1/7 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	0.00% 0/59 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	0.00% 0/3 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	0.00% 0/11 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	0.00% 0/29 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	0.00% 0/42 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	0.00% 0/22 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders	0.00% 0/3 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	0.00% 0/8 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	0.00% 0/7 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	3.4% 2/59 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	0.00% 0/3 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	0.00% 0/11 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	3.4% 1/29 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	4.8% 2/42 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.	0.00% 0/22 • All the TEAEs from first dose to 90 days after the last dose of toripalimab were included in the safety evaluation, an average duration of six months, up to two years. Safety data are based on the June 7, 2022 data cut-off date.

Additional Information

Dr. Kevin Li

TopAlliance BioSciences

Phone: 301-640-5166

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place