Trial Outcomes & Findings for Study of NKTR 255 in Combination With Cetuximab in Solid Tumors (NCT NCT04616196)

Last Updated: 2025-06-08

Results Overview

Safety and tolerability of NKTR-255 in combination with cetuximab as evaluated by dose limiting toxicities, incidence of drug-related Adverse Events (AEs), SAEs, and AEs leading to discontinuation, deaths, and clinical laboratory abnormalities per CTCAE 5.0

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

25 participants

Primary outcome timeframe

60 days after the last dose of study treatment, up to an average of 6 months.

Results posted on

2025-06-08

Participant Flow

The Phase 1 portion of the study was completed. The Phase 2 cohort enrollment was not initiated.

Participant milestones

Participant milestones
Measure	Dose Escalation of NKTR-255 Level 1 (1.5 µg/kg) With Cetuximab Establish RP2D, of NKTR-255 with cetuximab. NKTR-255: NKTR-255 IV every 21 days Cetuximab: Cetuximab will be given at specified doses on specified days	Dose Escalation of NKTR-255 Level 2 (3.0 µg/kg) With Cetuximab Establish RP2D, of NKTR-255 with cetuximab. NKTR-255: NKTR-255 IV every 21 days Cetuximab: Cetuximab will be given at specified doses on specified days	Dose Escalation of NKTR-255 Level 3 (4.5 µg/kg) With Cetuximab Establish RP2D, of NKTR-255 with cetuximab. NKTR-255: NKTR-255 IV every 21 days Cetuximab: Cetuximab will be given at specified doses on specified days	Dose Escalation of NKTR-255 Level 4 (6.0 µg/kg) With Cetuximab Establish RP2D, of NKTR-255 with cetuximab. NKTR-255: NKTR-255 IV every 21 days Cetuximab: Cetuximab will be given at specified doses on specified days
Overall Study STARTED	8	8	6	3
Overall Study Number of Participants Who Were Included in the "Safety Population" Analysis.	7	7	6	3
Overall Study COMPLETED	0	1	0	0
Overall Study NOT COMPLETED	8	7	6	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Dose Escalation of NKTR-255 Level 1 (1.5 µg/kg) With Cetuximab Establish RP2D, of NKTR-255 with cetuximab. NKTR-255: NKTR-255 IV every 21 days Cetuximab: Cetuximab will be given at specified doses on specified days	Dose Escalation of NKTR-255 Level 2 (3.0 µg/kg) With Cetuximab Establish RP2D, of NKTR-255 with cetuximab. NKTR-255: NKTR-255 IV every 21 days Cetuximab: Cetuximab will be given at specified doses on specified days	Dose Escalation of NKTR-255 Level 3 (4.5 µg/kg) With Cetuximab Establish RP2D, of NKTR-255 with cetuximab. NKTR-255: NKTR-255 IV every 21 days Cetuximab: Cetuximab will be given at specified doses on specified days	Dose Escalation of NKTR-255 Level 4 (6.0 µg/kg) With Cetuximab Establish RP2D, of NKTR-255 with cetuximab. NKTR-255: NKTR-255 IV every 21 days Cetuximab: Cetuximab will be given at specified doses on specified days
Overall Study Progressive Disease	3	0	4	1
Overall Study Death	2	4	1	0
Overall Study Withdrawal by Subject	0	2	0	0
Overall Study Lost to Follow-up	1	0	0	0
Overall Study Sponsor request	2	1	1	2

Baseline Characteristics

The number analyzed for height is less than the overall number of baseline participants, since there was missing patient data.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dose Escalation of NKTR-255 Level 1 (1.5 µg/kg) With Cetuximab n=7 Participants Establish RP2D, of NKTR-255 with cetuximab. NKTR-255: NKTR-255 IV every 21 days Cetuximab: Cetuximab will be given at specified doses on specified days	Dose Escalation of NKTR-255 Level 2 (3.0 µg/kg) With Cetuximab n=7 Participants Establish RP2D, of NKTR-255 with cetuximab. NKTR-255: NKTR-255 IV every 21 days Cetuximab: Cetuximab will be given at specified doses on specified days	Dose Escalation of NKTR-255 Level 3 (4.5 µg/kg) With Cetuximab n=6 Participants Establish RP2D, of NKTR-255 with cetuximab. NKTR-255: NKTR-255 IV every 21 days Cetuximab: Cetuximab will be given at specified doses on specified days	Dose Escalation of NKTR-255 Level 4 (6.0 µg/kg) With Cetuximab n=3 Participants Establish RP2D, of NKTR-255 with cetuximab. NKTR-255: NKTR-255 IV every 21 days Cetuximab: Cetuximab will be given at specified doses on specified days	Total n=23 Participants Total of all reporting groups
Age, Continuous	60.7 years STANDARD_DEVIATION 7.3 • n=7 Participants	56.9 years STANDARD_DEVIATION 11.44 • n=7 Participants	60.7 years STANDARD_DEVIATION 18.02 • n=6 Participants	59.0 years STANDARD_DEVIATION 11.00 • n=3 Participants	59.3 years STANDARD_DEVIATION 11.75 • n=23 Participants
Age, Customized <65	5 participants n=7 Participants	4 participants n=7 Participants	3 participants n=6 Participants	2 participants n=3 Participants	14 participants n=23 Participants
Age, Customized >=65 and <75	2 participants n=7 Participants	3 participants n=7 Participants	2 participants n=6 Participants	1 participants n=3 Participants	8 participants n=23 Participants
Age, Customized >=75 and <85	0 participants n=7 Participants	0 participants n=7 Participants	1 participants n=6 Participants	0 participants n=3 Participants	1 participants n=23 Participants
Age, Customized >=85	0 participants n=7 Participants	0 participants n=7 Participants	0 participants n=6 Participants	0 participants n=3 Participants	0 participants n=23 Participants
Sex: Female, Male Female	0 Participants n=7 Participants	2 Participants n=7 Participants	3 Participants n=6 Participants	1 Participants n=3 Participants	6 Participants n=23 Participants
Sex: Female, Male Male	7 Participants n=7 Participants	5 Participants n=7 Participants	3 Participants n=6 Participants	2 Participants n=3 Participants	17 Participants n=23 Participants
Race/Ethnicity, Customized Hispanic or Latino	1 Participants n=7 Participants	1 Participants n=7 Participants	2 Participants n=6 Participants	0 Participants n=3 Participants	4 Participants n=23 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	5 Participants n=7 Participants	6 Participants n=7 Participants	4 Participants n=6 Participants	3 Participants n=3 Participants	18 Participants n=23 Participants
Race/Ethnicity, Customized Not Reported	1 Participants n=7 Participants	1 Participants n=7 Participants	0 Participants n=6 Participants	1 Participants n=3 Participants	3 Participants n=23 Participants
Race/Ethnicity, Customized Unknown	1 Participants n=7 Participants	0 Participants n=7 Participants	1 Participants n=6 Participants	0 Participants n=3 Participants	2 Participants n=23 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=7 Participants	0 Participants n=7 Participants	0 Participants n=6 Participants	0 Participants n=3 Participants	0 Participants n=23 Participants
Race/Ethnicity, Customized Asian	0 Participants n=7 Participants	0 Participants n=7 Participants	0 Participants n=6 Participants	1 Participants n=3 Participants	1 Participants n=23 Participants
Race/Ethnicity, Customized Black or African American	1 Participants n=7 Participants	1 Participants n=7 Participants	0 Participants n=6 Participants	0 Participants n=3 Participants	2 Participants n=23 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Participants n=7 Participants	0 Participants n=7 Participants	0 Participants n=6 Participants	0 Participants n=3 Participants	0 Participants n=23 Participants
Race/Ethnicity, Customized White	4 Participants n=7 Participants	5 Participants n=7 Participants	5 Participants n=6 Participants	1 Participants n=3 Participants	15 Participants n=23 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status ECOG PS 0	2 Participants n=7 Participants	4 Participants n=7 Participants	3 Participants n=6 Participants	1 Participants n=3 Participants	10 Participants n=23 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status ECOG PS 1	5 Participants n=7 Participants	3 Participants n=7 Participants	3 Participants n=6 Participants	2 Participants n=3 Participants	13 Participants n=23 Participants
Height	176.69 centimeter STANDARD_DEVIATION 6.370 • n=6 Participants • The number analyzed for height is less than the overall number of baseline participants, since there was missing patient data.	171.78 centimeter STANDARD_DEVIATION 7.202 • n=7 Participants • The number analyzed for height is less than the overall number of baseline participants, since there was missing patient data.	167.90 centimeter STANDARD_DEVIATION 14.675 • n=6 Participants • The number analyzed for height is less than the overall number of baseline participants, since there was missing patient data.	168.54 centimeter STANDARD_DEVIATION 3.062 • n=2 Participants • The number analyzed for height is less than the overall number of baseline participants, since there was missing patient data.	171.76 centimeter STANDARD_DEVIATION 9.635 • n=21 Participants • The number analyzed for height is less than the overall number of baseline participants, since there was missing patient data.
Weight	91.77 kg STANDARD_DEVIATION 14.415 • n=7 Participants	84.20 kg STANDARD_DEVIATION 14.359 • n=7 Participants	87.46 kg STANDARD_DEVIATION 44.884 • n=6 Participants	70.98 kg STANDARD_DEVIATION 17.727 • n=3 Participants	85.63 kg STANDARD_DEVIATION 25.341 • n=23 Participants
Body Mass Index (BMI)	30.13 kg/m^2 STANDARD_DEVIATION 4.227 • n=6 Participants • The number analyzed for BMI is less than the overall number of baseline participants, since there was missing patient data.	28.89 kg/m^2 STANDARD_DEVIATION 6.997 • n=7 Participants • The number analyzed for BMI is less than the overall number of baseline participants, since there was missing patient data.	29.98 kg/m^2 STANDARD_DEVIATION 10.569 • n=6 Participants • The number analyzed for BMI is less than the overall number of baseline participants, since there was missing patient data.	22.00 kg/m^2 STANDARD_DEVIATION 4.414 • n=2 Participants • The number analyzed for BMI is less than the overall number of baseline participants, since there was missing patient data.	28.90 kg/m^2 STANDARD_DEVIATION 7.323 • n=21 Participants • The number analyzed for BMI is less than the overall number of baseline participants, since there was missing patient data.

PRIMARY outcome

Timeframe: 60 days after the last dose of study treatment, up to an average of 6 months.

Population: DLTs were assessed using the DLT Population, which only included patients who received at least 1 dose of the combination treatment of NKTR-255 and cetuximab and who completed the DLT observation period or discontinued from the study treatment due to a DLT, where DLT window was 21 days since the first dose of NKTR-255. The other rows were assessed using the Safety Population, patients who received at least 1 dose (or partial dose) of NKTR-255.

Outcome measures

Outcome measures
Measure	Dose Escalation of NKTR-255 Level 1 (1.5 µg/kg) With Cetuximab n=7 Participants NKTR-255: NKTR-255 IV every 21 days Cetuximab: Cetuximab will be given at specified doses on specified days	Dose Escalation of NKTR-255 Level 2 (3.0 µg/kg) With Cetuximab n=7 Participants NKTR-255: NKTR-255 IV every 21 days Cetuximab: Cetuximab will be given at specified doses on specified days	Dose Escalation of NKTR-255 Level 3 (4.5 µg/kg) With Cetuximab n=6 Participants NKTR-255: NKTR-255 IV every 21 days Cetuximab: Cetuximab will be given at specified doses on specified days	Dose Escalation of NKTR-255 Level 4 (6.0 µg/kg) With Cetuximab n=3 Participants NKTR-255: NKTR-255 IV every 21 days Cetuximab: Cetuximab will be given at specified doses on specified days
Incidence of Treatment-Emergent Adverse Events (TEAE) and Serious Adverse Events (SAE) of NKTR-255 in Combination With Cetuximab in R/R HNSCC or CRC for Phase 1b Dose Escalation Patients With at Least one TEAE	7 Participants	7 Participants	6 Participants	2 Participants
Incidence of Treatment-Emergent Adverse Events (TEAE) and Serious Adverse Events (SAE) of NKTR-255 in Combination With Cetuximab in R/R HNSCC or CRC for Phase 1b Dose Escalation Patients With at Least one Serious TEAE	2 Participants	2 Participants	5 Participants	1 Participants
Incidence of Treatment-Emergent Adverse Events (TEAE) and Serious Adverse Events (SAE) of NKTR-255 in Combination With Cetuximab in R/R HNSCC or CRC for Phase 1b Dose Escalation Patients With at Least one Serious TEAE Related to NKTR-255	0 Participants	1 Participants	0 Participants	1 Participants
Incidence of Treatment-Emergent Adverse Events (TEAE) and Serious Adverse Events (SAE) of NKTR-255 in Combination With Cetuximab in R/R HNSCC or CRC for Phase 1b Dose Escalation Patients With at Least one TEAE Leading to NKTR-255 Delay, Reduction, or Interruption	2 Participants	0 Participants	2 Participants	0 Participants
Incidence of Treatment-Emergent Adverse Events (TEAE) and Serious Adverse Events (SAE) of NKTR-255 in Combination With Cetuximab in R/R HNSCC or CRC for Phase 1b Dose Escalation Patients with dose limiting toxicities (DLTs): Infusion related reaction	0 Participants	1 Participants	0 Participants	0 Participants
Incidence of Treatment-Emergent Adverse Events (TEAE) and Serious Adverse Events (SAE) of NKTR-255 in Combination With Cetuximab in R/R HNSCC or CRC for Phase 1b Dose Escalation Patients With at Least one TEAE Related to NKTR-255	5 Participants	7 Participants	5 Participants	2 Participants
Incidence of Treatment-Emergent Adverse Events (TEAE) and Serious Adverse Events (SAE) of NKTR-255 in Combination With Cetuximab in R/R HNSCC or CRC for Phase 1b Dose Escalation Patients With at Least one TEAE Leading to Death	0 Participants	0 Participants	0 Participants	0 Participants
Incidence of Treatment-Emergent Adverse Events (TEAE) and Serious Adverse Events (SAE) of NKTR-255 in Combination With Cetuximab in R/R HNSCC or CRC for Phase 1b Dose Escalation Patients With at Least one TEAE Related to NKTR-255 Leading to Death	0 Participants	0 Participants	0 Participants	0 Participants
Incidence of Treatment-Emergent Adverse Events (TEAE) and Serious Adverse Events (SAE) of NKTR-255 in Combination With Cetuximab in R/R HNSCC or CRC for Phase 1b Dose Escalation Patients With at Least one TEAE Leading to NKTR-255 Discontinuation	0 Participants	2 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Up to 21 days

To define the MTD and/or RP2D of NKTR-255 in combination with cetuximab in R/R HNSCC or CRC for Phase 1b Dose Escalation

Outcome measures

Outcome measures
Measure	Dose Escalation of NKTR-255 Level 1 (1.5 µg/kg) With Cetuximab n=7 Participants NKTR-255: NKTR-255 IV every 21 days Cetuximab: Cetuximab will be given at specified doses on specified days	Dose Escalation of NKTR-255 Level 2 (3.0 µg/kg) With Cetuximab n=7 Participants NKTR-255: NKTR-255 IV every 21 days Cetuximab: Cetuximab will be given at specified doses on specified days	Dose Escalation of NKTR-255 Level 3 (4.5 µg/kg) With Cetuximab n=6 Participants NKTR-255: NKTR-255 IV every 21 days Cetuximab: Cetuximab will be given at specified doses on specified days	Dose Escalation of NKTR-255 Level 4 (6.0 µg/kg) With Cetuximab n=3 Participants NKTR-255: NKTR-255 IV every 21 days Cetuximab: Cetuximab will be given at specified doses on specified days
The Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D) of NKTR-255 in Combination With Cetuximab in R/R HNSCC or CRC for Phase 1b Dose Escalation	NA µg/kg MTD was not established. There were no dose limiting toxicity in the highest dose of 6 µg/kg and above, therefore there was no MTD.	NA µg/kg MTD was not established. There were no dose limiting toxicity in the highest dose of 6 µg/kg and above, therefore there was no MTD.	NA µg/kg MTD was not established. There were no dose limiting toxicity in the highest dose of 6 µg/kg and above, therefore there was no MTD.	NA µg/kg MTD was not established. There were no dose limiting toxicity in the highest dose of 6 µg/kg and above, therefore there was no MTD.

Adverse Events

Dose Escalation of NKTR-255 Level 1 (1.5 µg/kg) With Cetuximab

Serious events: 2 serious events

Other events: 7 other events

Deaths: 2 deaths

Dose Escalation of NKTR-255 Level 2 (3.0 µg/kg) With Cetuximab

Serious events: 2 serious events

Other events: 7 other events

Deaths: 4 deaths

Dose Escalation of NKTR-255 Level 3 (4.5 µg/kg) With Cetuximab

Serious events: 5 serious events

Other events: 6 other events

Deaths: 1 deaths

Dose Escalation of NKTR-255 Level 4 (6.0 µg/kg) With Cetuximab

Serious events: 1 serious events

Other events: 2 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Dose Escalation of NKTR-255 Level 1 (1.5 µg/kg) With Cetuximab n=7 participants at risk NKTR-255: NKTR-255 IV every 21 days Cetuximab: Cetuximab will be given at specified doses on specified days	Dose Escalation of NKTR-255 Level 2 (3.0 µg/kg) With Cetuximab n=7 participants at risk NKTR-255: NKTR-255 IV every 21 days Cetuximab: Cetuximab will be given at specified doses on specified days	Dose Escalation of NKTR-255 Level 3 (4.5 µg/kg) With Cetuximab n=6 participants at risk NKTR-255: NKTR-255 IV every 21 days Cetuximab: Cetuximab will be given at specified doses on specified days	Dose Escalation of NKTR-255 Level 4 (6.0 µg/kg) With Cetuximab n=3 participants at risk NKTR-255: NKTR-255 IV every 21 days Cetuximab: Cetuximab will be given at specified doses on specified days
Gastrointestinal disorders Small intestinal obstruction	14.3% 1/7 • Through study completion, up to 6 months. Adverse events were collected through regular investigator assessments and regular laboratory testing.	0.00% 0/7 • Through study completion, up to 6 months. Adverse events were collected through regular investigator assessments and regular laboratory testing.	0.00% 0/6 • Through study completion, up to 6 months. Adverse events were collected through regular investigator assessments and regular laboratory testing.	0.00% 0/3 • Through study completion, up to 6 months. Adverse events were collected through regular investigator assessments and regular laboratory testing.
General disorders Asthenia	14.3% 1/7 • Through study completion, up to 6 months. Adverse events were collected through regular investigator assessments and regular laboratory testing.	0.00% 0/7 • Through study completion, up to 6 months. Adverse events were collected through regular investigator assessments and regular laboratory testing.	0.00% 0/6 • Through study completion, up to 6 months. Adverse events were collected through regular investigator assessments and regular laboratory testing.	0.00% 0/3 • Through study completion, up to 6 months. Adverse events were collected through regular investigator assessments and regular laboratory testing.
Immune system disorders Cytokine release syndrome	0.00% 0/7 • Through study completion, up to 6 months. Adverse events were collected through regular investigator assessments and regular laboratory testing.	0.00% 0/7 • Through study completion, up to 6 months. Adverse events were collected through regular investigator assessments and regular laboratory testing.	0.00% 0/6 • Through study completion, up to 6 months. Adverse events were collected through regular investigator assessments and regular laboratory testing.	33.3% 1/3 • Through study completion, up to 6 months. Adverse events were collected through regular investigator assessments and regular laboratory testing.
Infections and infestations Cellulitis	0.00% 0/7 • Through study completion, up to 6 months. Adverse events were collected through regular investigator assessments and regular laboratory testing.	0.00% 0/7 • Through study completion, up to 6 months. Adverse events were collected through regular investigator assessments and regular laboratory testing.	16.7% 1/6 • Through study completion, up to 6 months. Adverse events were collected through regular investigator assessments and regular laboratory testing.	0.00% 0/3 • Through study completion, up to 6 months. Adverse events were collected through regular investigator assessments and regular laboratory testing.
Infections and infestations Lung infection	0.00% 0/7 • Through study completion, up to 6 months. Adverse events were collected through regular investigator assessments and regular laboratory testing.	0.00% 0/7 • Through study completion, up to 6 months. Adverse events were collected through regular investigator assessments and regular laboratory testing.	16.7% 1/6 • Through study completion, up to 6 months. Adverse events were collected through regular investigator assessments and regular laboratory testing.	0.00% 0/3 • Through study completion, up to 6 months. Adverse events were collected through regular investigator assessments and regular laboratory testing.
Infections and infestations Peritonitis	14.3% 1/7 • Through study completion, up to 6 months. Adverse events were collected through regular investigator assessments and regular laboratory testing.	0.00% 0/7 • Through study completion, up to 6 months. Adverse events were collected through regular investigator assessments and regular laboratory testing.	0.00% 0/6 • Through study completion, up to 6 months. Adverse events were collected through regular investigator assessments and regular laboratory testing.	0.00% 0/3 • Through study completion, up to 6 months. Adverse events were collected through regular investigator assessments and regular laboratory testing.
Infections and infestations Sepsis	0.00% 0/7 • Through study completion, up to 6 months. Adverse events were collected through regular investigator assessments and regular laboratory testing.	0.00% 0/7 • Through study completion, up to 6 months. Adverse events were collected through regular investigator assessments and regular laboratory testing.	16.7% 1/6 • Through study completion, up to 6 months. Adverse events were collected through regular investigator assessments and regular laboratory testing.	0.00% 0/3 • Through study completion, up to 6 months. Adverse events were collected through regular investigator assessments and regular laboratory testing.
Infections and infestations Urinary tract infection	0.00% 0/7 • Through study completion, up to 6 months. Adverse events were collected through regular investigator assessments and regular laboratory testing.	0.00% 0/7 • Through study completion, up to 6 months. Adverse events were collected through regular investigator assessments and regular laboratory testing.	16.7% 1/6 • Through study completion, up to 6 months. Adverse events were collected through regular investigator assessments and regular laboratory testing.	0.00% 0/3 • Through study completion, up to 6 months. Adverse events were collected through regular investigator assessments and regular laboratory testing.
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/7 • Through study completion, up to 6 months. Adverse events were collected through regular investigator assessments and regular laboratory testing.	14.3% 1/7 • Through study completion, up to 6 months. Adverse events were collected through regular investigator assessments and regular laboratory testing.	0.00% 0/6 • Through study completion, up to 6 months. Adverse events were collected through regular investigator assessments and regular laboratory testing.	0.00% 0/3 • Through study completion, up to 6 months. Adverse events were collected through regular investigator assessments and regular laboratory testing.
Nervous system disorders Syncope	0.00% 0/7 • Through study completion, up to 6 months. Adverse events were collected through regular investigator assessments and regular laboratory testing.	0.00% 0/7 • Through study completion, up to 6 months. Adverse events were collected through regular investigator assessments and regular laboratory testing.	16.7% 1/6 • Through study completion, up to 6 months. Adverse events were collected through regular investigator assessments and regular laboratory testing.	0.00% 0/3 • Through study completion, up to 6 months. Adverse events were collected through regular investigator assessments and regular laboratory testing.
Renal and urinary disorders Urinary tract obstruction	0.00% 0/7 • Through study completion, up to 6 months. Adverse events were collected through regular investigator assessments and regular laboratory testing.	0.00% 0/7 • Through study completion, up to 6 months. Adverse events were collected through regular investigator assessments and regular laboratory testing.	16.7% 1/6 • Through study completion, up to 6 months. Adverse events were collected through regular investigator assessments and regular laboratory testing.	0.00% 0/3 • Through study completion, up to 6 months. Adverse events were collected through regular investigator assessments and regular laboratory testing.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/7 • Through study completion, up to 6 months. Adverse events were collected through regular investigator assessments and regular laboratory testing.	14.3% 1/7 • Through study completion, up to 6 months. Adverse events were collected through regular investigator assessments and regular laboratory testing.	0.00% 0/6 • Through study completion, up to 6 months. Adverse events were collected through regular investigator assessments and regular laboratory testing.	0.00% 0/3 • Through study completion, up to 6 months. Adverse events were collected through regular investigator assessments and regular laboratory testing.
Infections and infestations Pneumonia	0.00% 0/7 • Through study completion, up to 6 months. Adverse events were collected through regular investigator assessments and regular laboratory testing.	0.00% 0/7 • Through study completion, up to 6 months. Adverse events were collected through regular investigator assessments and regular laboratory testing.	16.7% 1/6 • Through study completion, up to 6 months. Adverse events were collected through regular investigator assessments and regular laboratory testing.	0.00% 0/3 • Through study completion, up to 6 months. Adverse events were collected through regular investigator assessments and regular laboratory testing.

Other adverse events

Additional Information

Study Director

Nektar Therapeutics

Phone: 855-482-8676

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee There are restrictions to the PI's rights to discuss or publish trial results after the trial is completed.
Publication restrictions are in place

Restriction type: OTHER