Study of NKTR 255 in Combination With Cetuximab in Solid Tumors

• Status: Recruiting
• Trial end date: 2023-04-01
• Target enrollment: 0
• Participant gender: All

Summary

Patients with relapsed or refractory (R/R) head and neck squamous cell carcinoma (HNSCC) or colorectal carcinoma (CRC) will receive a loading dose of cetuximab alone, followed 7 days later by the first combination treatment of cetuximab and NKTR-255 on Cycle 1 Day 1 (C1D1). Thereafter, intravenous (IV) NKTR-255 will be given in 21-day cycles in combination with weekly IV cetuximab. After determination of the recommended Phase 2 dose (RP2D) of NKTR-255 in combination with cetuximab, this dose of NKTR-255 will be further studied in patients with HNSCC (Cohort A) and CRC (Cohort B) in Phase 2 of the study.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nektar Therapeutics
• Treatments: Cetuximab

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.

CRC: Patients with microsatellite instability-high (MSI-H) or mismatched repair disease (dMMR) tumors must have been exposed to checkpoint inhibitors such as anti-PD-(L)1 or anticytotoxic T-lymphocyte-associated protein (CTLA)-4 antibody.

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

• Contraindication to or unable to receive cetuximab