Study of NKTR 255 in Combination With Cetuximab in Solid Tumors

Phase 1

Completed

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.

Recruitment & Eligibility

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/exclusion criteria may apply

Arm && Interventions

Group	Intervention	Description
Dose Escalation of NKTR-255 with Cetuximab	NKTR-255	Establish RP2D, of NKTR-255 with cetuximab.
Dose Escalation of NKTR-255 with Cetuximab	Cetuximab	Establish RP2D, of NKTR-255 with cetuximab.

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method

Locations (6): University of California, San Diego
🇺🇸
San Diego, California, United States
University of California, San Francisco
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San Francisco, California, United States
University of Minnesota
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Minneapolis, Minnesota, United States
Mary Crowley Cancer Research
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Dallas, Texas, United States
MD Anderson Cancer Center
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Houston, Texas, United States
START Center for Cancer Care
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San Antonio, Texas, United States
University of California, San Diego
🇺🇸San Diego, California, United States