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Study of NKTR 255 in Combination With Cetuximab in Solid Tumors | Clinical Trials | Clareo Health

COMPLETEDPHASE1/PHASE2

Study of NKTR 255 in Combination With Cetuximab in Solid Tumors

A Phase 1b/2, Open-label, Multicenter, Dose Escalation and Dose Expansion Study of NKTR-255 Monotherapy or in Combination With Cetuximab as a Salvage Regimen for Solid Tumors

NCT04616196•Nektar Therapeutics

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.

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

Locations (6)

University of California, San Diego

San Diego, California, United States

University of California, San Francisco

San Francisco, California, United States

University of Minnesota

Minneapolis, Minnesota, United States

Mary Crowley Cancer Research

Dallas, Texas, United States

MD Anderson Cancer Center

Houston, Texas, United States

START Center for Cancer Care

San Antonio, Texas, United States

Key Dates

Start Date

October 30, 2020

Primary Completion Date

March 30, 2023

Completion Date

March 30, 2023

Last Updated

June 8, 2025

Enrollment

ACTUAL participants

Conditions

Head and Neck Squamous Cell CarcinomaColorectal Cancer

Interventions

NKTR-255

DRUG

Cetuximab

DRUG

Testing the Combination of Two Anti-cancer Drugs, DS-8201a and AZD6738, for The Treatment of Advanced Solid Tumors Expressing the HER2 Protein or Gene, The DASH Trial

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Advanced Breast CarcinomaAdvanced Colon Carcinoma+38 more

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RECRUITINGPHASE2

Testing Whether Cemiplimab (REGN2810) Plus CDX-1140 Given Prior to Surgery Are Better Than Cemiplimab (REGN2810) Alone in Patients With Stage III-IV Head and Neck Cancer

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Head and Neck Squamous Cell CarcinomaHypopharyngeal Squamous Cell Carcinoma+20 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 8, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Study of NKTR 255 in Combination With Cetuximab in Solid Tumors

Inclusion Criteria

Exclusion Criteria

Testing the Combination of Two Anti-cancer Drugs, DS-8201a and AZD6738, for The Treatment of Advanced Solid Tumors Expressing the HER2 Protein or Gene, The DASH Trial

Testing Whether Cemiplimab (REGN2810) Plus CDX-1140 Given Prior to Surgery Are Better Than Cemiplimab (REGN2810) Alone in Patients With Stage III-IV Head and Neck Cancer

IACS-6274 With or Without Bevacizumab and Paclitaxel for the Treatment of Advanced Solid Tumors

Clinical Trial of an Anti-cancer Drug, CA-4948 (Emavusertib), in Combination With Chemotherapy Treatment (FOLFOX Plus Bevacizumab) in Metastatic Colorectal Cancer

Study of Dato-DXd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)

A Study of ART0380 for the Treatment of Advanced or Metastatic Solid Tumors