Study of NKTR 255 in Combination With Cetuximab in Solid Tumors

NCT04616196 | Completed Phase 1 Results DMC FDA Drug

• 1 other identifier: 19-255-03
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 6

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).

Conditions

Head and Neck Squamous Cell Carcinoma; Colorectal Cancer

Keywords

HNSCC; Head and Neck Squamous Cell Carcinoma; CRC; Colorectal Cancer; NKTR-255; Cetuximab; Erbitux®

Outcome Measures

Primary Outcomes (2)

• 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

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

• 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

  Up to 21 days

Study Arms (1)

Dose Escalation of NKTR-255 with Cetuximab

EXPERIMENTAL

Establish RP2D, of NKTR-255 with cetuximab.

Drug: NKTR-255; Drug: Cetuximab

Interventions

NKTR-255 DRUG

NKTR-255 IV every 21 days

Dose Escalation of NKTR-255 with Cetuximab

Cetuximab DRUG

Cetuximab will be given at specified doses on specified days

Also known as: Erbitux®

Dose Escalation of NKTR-255 with Cetuximab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Nektar Therapeutics: lead

Study Sites (6)

University of California, San Diego

San Diego, California, 92103, United States

Location

University of California, San Francisco

San Francisco, California, 94158, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Mary Crowley Cancer Research

Dallas, Texas, 75230, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

START Center for Cancer Care

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck; Colorectal Neoplasms

Interventions

NKTR-255; Cetuximab

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Study Director
• Organization: Nektar Therapeutics

StudyInquiry@nektar.com

855-482-8676

Study Officials

• Study Director

  Nektar Therapeutics

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Phase 1: Dose escalation cohorts will be sequential

Study Record Dates

• First Submitted: October 30, 2020
• First Posted: November 4, 2020
• Study Start: October 30, 2020
• Primary Completion: March 30, 2023
• Study Completion: March 30, 2023
• Last Updated: June 8, 2025
• Results First Posted: June 8, 2025

Record last verified: 2025-05

Locations

US (6)