Toripalimab(JS001) as Monotherapy in Participants With POLE or POLD-1 Mutated and Non-MSI-H Advanced Solid Tumors
NCT03810339 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 35
Last updated 2026-04-23
Summary
The purpose of this study is to evaluate the response of toripalimab (JS001), a PD1 antibody, in participants with POLE or POLD-mutated and non microsatellite instability (non-MSI-H) advanced solid cancers.
Conditions
Interventions
- DRUG
-
Toripalimab
Toripalimab, 240mg, every 3 weeks until disease progress or intolerable toxicity
Sponsors & Collaborators
-
Sun Yat-sen University
lead OTHER
Principal Investigators
-
Rui-hua Xu, MD, PhD · Sun Yat-Sen University Cancer Center
-
FENG WANG, MD,PhD · Sun Yat-Sen University Cancer Center
-
Ying Jin · Sun Yat-Sen University Cancer Center
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-01-15
- Primary Completion
- 2028-01-15
- Completion
- 2029-12-31
Countries
- China
Study Locations
More Related Trials
-
Study of Toripalimab for Limited-Stage Small Cell Lung Cancer Following Concurrent Chemoradiotherapy
NCT04418648 ·Status: TERMINATED ·Phase: PHASE2
-
A Clinical Study to Evaluate the Safety and Tolerability of JS107 in Advanced or Metastatic Solid Tumors
NCT05502393 ·Status: UNKNOWN ·Phase: PHASE1
-
Study of JS004 Combined With Toripalimab for Advanced Lung Cancer
NCT05000684 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Toripalimab in Combination With Platinum-based Chemotherapy for Mutation-negative Stage IV Oligometastatic NSCLC
NCT05055583 ·Status: UNKNOWN ·Phase: PHASE2
-
Toripalimab or Placebo With Paclitaxel and Cisplatin in Esophageal Squamous Cell Carcinoma
NCT03829969 ·Status: COMPLETED ·Phase: PHASE3
-
A Study of Toripalimab as Consolidation Therapy After Postoperative Chemoradiotherapy in HNSCC
NCT04992559 ·Status: RECRUITING ·Phase: PHASE2
-
Tolerability and Pharmacokinetics of Toripalimab in Combination With Axitinib in Patients With Kidney Cancer and Melanoma
NCT03086174 ·Status: UNKNOWN ·Phase: PHASE1
-
The Effect of Toripalimab Plus Radiotherapy in Patients With Operable Stage II-IIIA (N+) Non Small Cell Lung Cancer
NCT05798845 ·Status: RECRUITING ·Phase: PHASE2
-
The Recombinant Humanized Anti-TIGIT Monoclonal Antibody (JS006) Monotherapy and in Combination With Toripalimab in Patients With Advanced Tumor
NCT05061628 ·Status: UNKNOWN ·Phase: PHASE1
-
JS001+IMP4297 in Patients With Advanced Cancer
NCT05262842 ·Status: WITHDRAWN ·Phase: PHASE1
-
Phase II Trial of Neoadjuvant and Adjuvant Anti-PD-1 Antibody Toripalimab Combined With CCRT in NPC Patients
NCT03925090 ·Status: UNKNOWN ·Phase: PHASE2
-
A Study of ILB2109 and Toripalimab in Patients With Advanced Solid Malignancies
NCT05955105 ·Status: RECRUITING ·Phase: PHASE1/PHASE2
-
Toripalimab Combined With Cryoablation for First-line Oligo-progression in Driver-negative Advanced NSCLC
NCT06127303 ·Status: RECRUITING ·Phase: PHASE2
-
A Study Explore JS001+JS002 in Patients With Advanced Cancer
NCT05128539 ·Status: TERMINATED ·Phase: PHASE1
-
Neoadjuvant JS001, or JS001 in Combination With Pemetrexed and Carboplatin in Resectable NSCLC.
NCT03623776 ·Status: WITHDRAWN ·Phase: PHASE2
-
A Study of Toripalimab+ Pemetrexed Plus Carboplatin in Patients With EGFR-mutation Positive and T790M Negative After Progression on EGFR-TKI Treatment
NCT03513666 ·Status: COMPLETED ·Phase: PHASE2
-
A Study Evaluating Toripalimab Injection Combined With Standard Chemotherapy as a First-line Treatment for Locally Advanced or Metastatic Urothelial Carcinoma
NCT04568304 ·Status: NOT_YET_RECRUITING ·Phase: PHASE3
-
Toripalimab Combined With Chemoradiotherapy in Patients With Locoregionally-advanced Nasopharyngeal Carcinoma
NCT04446663 ·Status: UNKNOWN ·Phase: PHASE2
-
Radiotherapy Omitting Prophylactic Neck Irradiation With Neoadjuvant and Adjuvant Toripalimab in Nasopharyngeal Carcinoma
NCT07110558 ·Status: NOT_YET_RECRUITING ·Phase: PHASE2
-
A Clinical Study to Evaluate the Safety, Tolerability,JS019 in Patients With Advanced Solid Tumors
NCT05508373 ·Status: UNKNOWN ·Phase: PHASE1
-
Toripalimab Combined With Radiotherapy and Chemotherapy in the Treatment of SNMM After Endoscopic Surgery
NCT04879654 ·Status: RECRUITING ·Phase: PHASE2
-
Study of LTC004 Combine With Toripalimab in Patient With Solid Tumors Resistant to Immunotherapy
NCT06490068 ·Status: RECRUITING ·Phase: PHASE2
-
ctDNA-MRD Guided Consolidation Toripalimab in Stage IB-IIIA NSCLC
NCT06426511 ·Status: RECRUITING ·Phase: PHASE2
-
Toripalimab Combined With SBRT for NSCLC
NCT06293690 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Safety and Tolerability of a mRNA Vaccine Encoding Tumor-Specific Circular RNA Antigens in Combination With Anti-PD-1 Monoclonal Antibody in Patients With Advanced Solid Tumors
NCT07245901 ·Status: NOT_YET_RECRUITING ·Phase: PHASE1/PHASE2