Head and Neck Squamous Cell Carcinoma, Colorectal Cancer
Conditions
Keywords
HNSCC, Head and Neck Squamous Cell Carcinoma, CRC, Colorectal Cancer, NKTR-255, Cetuximab, Erbitux®
Brief summary
This is a Phase 1b/2, open-label multicenter study evaluating NKTR-255 as a monotherapy and together with cetuximab in patients with head and neck squamous cell carcinoma (HNSCC) and colorectal carcinoma (CRC).
Detailed description
NKTR-255 is a cytokine that is designed to regulate T and natural killer cell activation, proliferation and promote their anti-tumor effects. In the dose escalation (Phase 1/b) phase patients with HNSCC or CRC will be treated with ascending doses of NKTR-255 in combination with cetuximab, until the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D) is reached.
Interventions
DRUGNKTR-255
NKTR-255 IV every 21 days
DRUGCetuximab
Cetuximab will be given at specified doses on specified days
Sponsors
Nektar Therapeutics
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Phase 1: Dose escalation cohorts will be sequential
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Histologically confirmed diagnosis of a locally advanced or metastatic HNSCC or CRC. * Life expectancy \> 12 weeks as determined by the Investigator. * Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1. * Measurable disease per RECIST 1.1. HNSCC: * Progression on any first or second line platinum-based chemotherapy and/or anti-PD-1 or programmed death-ligand 1 antibody. CRC: * Patients must have received or were intolerant to at least 2 prior cancer therapy regimens administered for metastatic disease. Key
Exclusion criteria
* Use of an investigational agent or an investigational device within 28 days before administration of first dose of study drug(s) * Prior surgery or radiotherapy within 14 days of initiating study drug(s) * Evidence of clinically significant interstitial lung disease or active, noninfectious pneumonitis; active infection requiring systemic therapy within 7 days prior to dosing * Patients who have been previously treated with IL-2 or IL-15 * Known Grade 3 or 4 hypersensitivity reaction to cetuximab, history of allergy to red meat or tick bites, or history of positive test results for immunoglobulin E antibodies against cetuximab * Patients who have an active, known, or suspected autoimmune disease NOTE: Other protocol defined inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 60 days after the last dose of study treatment, up to an average of 6 months. | 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 |
| 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 | 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 |
Countries
United States
Participant flow
Pre-assignment details
The Phase 1 portion of the study was completed. The Phase 2 cohort enrollment was not initiated.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 7 |
| 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 | 7 |
| 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 | 6 |
| 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 | 3 |
| Total | 23 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Death | 2 | 4 | 1 | 0 |
| Overall Study | Lost to Follow-up | 1 | 0 | 0 | 0 |
| Overall Study | Progressive Disease | 3 | 0 | 4 | 1 |
| Overall Study | Sponsor request | 2 | 1 | 1 | 2 |
| Overall Study | Withdrawal by Subject | 0 | 2 | 0 | 0 |
Baseline characteristics
| Characteristic | Dose Escalation of NKTR-255 Level 1 (1.5 µg/kg) With Cetuximab | Dose Escalation of NKTR-255 Level 2 (3.0 µg/kg) With Cetuximab | Dose Escalation of NKTR-255 Level 3 (4.5 µg/kg) With Cetuximab | Dose Escalation of NKTR-255 Level 4 (6.0 µg/kg) With Cetuximab | Total |
|---|---|---|---|---|---|
| Age, Continuous | 60.7 years STANDARD_DEVIATION 7.3 | 56.9 years STANDARD_DEVIATION 11.44 | 60.7 years STANDARD_DEVIATION 18.02 | 59.0 years STANDARD_DEVIATION 11 | 59.3 years STANDARD_DEVIATION 11.75 |
| Age, Customized <65 | 5 participants | 4 participants | 3 participants | 2 participants | 14 participants |
| Age, Customized >=65 and <75 | 2 participants | 3 participants | 2 participants | 1 participants | 8 participants |
| Age, Customized >=75 and <85 | 0 participants | 0 participants | 1 participants | 0 participants | 1 participants |
| Age, Customized >=85 | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants |
| Body Mass Index (BMI) | 30.13 kg/m^2 STANDARD_DEVIATION 4.227 | 28.89 kg/m^2 STANDARD_DEVIATION 6.997 | 29.98 kg/m^2 STANDARD_DEVIATION 10.569 | 22.00 kg/m^2 STANDARD_DEVIATION 4.414 | 28.90 kg/m^2 STANDARD_DEVIATION 7.323 |
| Eastern Cooperative Oncology Group (ECOG) Performance Status ECOG PS 0 | 2 Participants | 4 Participants | 3 Participants | 1 Participants | 10 Participants |
| Eastern Cooperative Oncology Group (ECOG) Performance Status ECOG PS 1 | 5 Participants | 3 Participants | 3 Participants | 2 Participants | 13 Participants |
| Height | 176.69 centimeter STANDARD_DEVIATION 6.37 | 171.78 centimeter STANDARD_DEVIATION 7.202 | 167.90 centimeter STANDARD_DEVIATION 14.675 | 168.54 centimeter STANDARD_DEVIATION 3.062 | 171.76 centimeter STANDARD_DEVIATION 9.635 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Black or African American | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 1 Participants | 1 Participants | 2 Participants | 0 Participants | 4 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Not Hispanic or Latino | 5 Participants | 6 Participants | 4 Participants | 3 Participants | 18 Participants |
| Race/Ethnicity, Customized Not Reported | 1 Participants | 1 Participants | 0 Participants | 1 Participants | 3 Participants |
| Race/Ethnicity, Customized Unknown | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized White | 4 Participants | 5 Participants | 5 Participants | 1 Participants | 15 Participants |
| Sex: Female, Male Female | 0 Participants | 2 Participants | 3 Participants | 1 Participants | 6 Participants |
| Sex: Female, Male Male | 7 Participants | 5 Participants | 3 Participants | 2 Participants | 17 Participants |
| Weight | 91.77 kg STANDARD_DEVIATION 14.415 | 84.20 kg STANDARD_DEVIATION 14.359 | 87.46 kg STANDARD_DEVIATION 44.884 | 70.98 kg STANDARD_DEVIATION 17.727 | 85.63 kg STANDARD_DEVIATION 25.341 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 2 / 8 | 4 / 8 | 1 / 6 | 1 / 3 |
| other Total, other adverse events | 7 / 7 | 7 / 7 | 6 / 6 | 2 / 3 |
| serious Total, serious adverse events | 2 / 7 | 2 / 7 | 5 / 6 | 1 / 3 |
Outcome results
Primary
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
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
Time frame: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Dose Escalation of NKTR-255 Level 1 (1.5 µg/kg) With Cetuximab | 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 |
| Dose Escalation of NKTR-255 Level 1 (1.5 µg/kg) With Cetuximab | 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 |
| Dose Escalation of NKTR-255 Level 1 (1.5 µg/kg) With Cetuximab | 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 |
| Dose Escalation of NKTR-255 Level 1 (1.5 µg/kg) With Cetuximab | 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 |
| Dose Escalation of NKTR-255 Level 1 (1.5 µg/kg) With Cetuximab | 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 |
| Dose Escalation of NKTR-255 Level 1 (1.5 µg/kg) With Cetuximab | 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 |
| Dose Escalation of NKTR-255 Level 1 (1.5 µg/kg) With Cetuximab | 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 |
| Dose Escalation of NKTR-255 Level 1 (1.5 µg/kg) With Cetuximab | 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 |
| Dose Escalation of NKTR-255 Level 1 (1.5 µg/kg) With Cetuximab | 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 |
| Dose Escalation of NKTR-255 Level 2 (3.0 µg/kg) With Cetuximab | 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 | 2 Participants |
| Dose Escalation of NKTR-255 Level 2 (3.0 µg/kg) With Cetuximab | 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 | 1 Participants |
| Dose Escalation of NKTR-255 Level 2 (3.0 µg/kg) With Cetuximab | 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 | 0 Participants |
| Dose Escalation of NKTR-255 Level 2 (3.0 µg/kg) With Cetuximab | 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 |
| Dose Escalation of NKTR-255 Level 2 (3.0 µg/kg) With Cetuximab | 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 |
| Dose Escalation of NKTR-255 Level 2 (3.0 µg/kg) With Cetuximab | 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 |
| Dose Escalation of NKTR-255 Level 2 (3.0 µg/kg) With Cetuximab | 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 | 1 Participants |
| Dose Escalation of NKTR-255 Level 2 (3.0 µg/kg) With Cetuximab | 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 | 7 Participants |
| Dose Escalation of NKTR-255 Level 2 (3.0 µg/kg) With Cetuximab | 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 |
| Dose Escalation of NKTR-255 Level 3 (4.5 µg/kg) With Cetuximab | 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 |
| Dose Escalation of NKTR-255 Level 3 (4.5 µg/kg) With Cetuximab | 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 | 5 Participants |
| Dose Escalation of NKTR-255 Level 3 (4.5 µg/kg) With Cetuximab | 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 |
| Dose Escalation of NKTR-255 Level 3 (4.5 µg/kg) With Cetuximab | 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 |
| Dose Escalation of NKTR-255 Level 3 (4.5 µg/kg) With Cetuximab | 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 |
| Dose Escalation of NKTR-255 Level 3 (4.5 µg/kg) With Cetuximab | 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 | 6 Participants |
| Dose Escalation of NKTR-255 Level 3 (4.5 µg/kg) With Cetuximab | 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 |
| Dose Escalation of NKTR-255 Level 3 (4.5 µg/kg) With Cetuximab | 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 |
| Dose Escalation of NKTR-255 Level 3 (4.5 µg/kg) With Cetuximab | 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 |
| Dose Escalation of NKTR-255 Level 4 (6.0 µg/kg) With Cetuximab | 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 | 1 Participants |
| Dose Escalation of NKTR-255 Level 4 (6.0 µg/kg) With Cetuximab | 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 |
| Dose Escalation of NKTR-255 Level 4 (6.0 µg/kg) With Cetuximab | 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 | 2 Participants |
| Dose Escalation of NKTR-255 Level 4 (6.0 µg/kg) With Cetuximab | 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 | 1 Participants |
| Dose Escalation of NKTR-255 Level 4 (6.0 µg/kg) With Cetuximab | 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 |
| Dose Escalation of NKTR-255 Level 4 (6.0 µg/kg) With Cetuximab | 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 |
| Dose Escalation of NKTR-255 Level 4 (6.0 µg/kg) With Cetuximab | 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 | 2 Participants |
| Dose Escalation of NKTR-255 Level 4 (6.0 µg/kg) With Cetuximab | 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 | 0 Participants |
| Dose Escalation of NKTR-255 Level 4 (6.0 µg/kg) With Cetuximab | 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 |
Primary
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
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
Time frame: Up to 21 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dose Escalation of NKTR-255 Level 1 (1.5 µg/kg) With Cetuximab | 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 |
| Dose Escalation of NKTR-255 Level 2 (3.0 µg/kg) With Cetuximab | 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 |
| Dose Escalation of NKTR-255 Level 3 (4.5 µg/kg) With Cetuximab | 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 |
| Dose Escalation of NKTR-255 Level 4 (6.0 µg/kg) With Cetuximab | 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 |