Study of NKTR 255 in Combination With Cetuximab in Solid Tumors

  • STATUS
    Recruiting
  • End date
    Aug 26, 2024
  • participants needed
    326
  • sponsor
    Nektar Therapeutics
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Updated on 26 April 2022
See if I qualify
antiretroviral
measurable disease
carcinoma
squamous cell carcinoma
cetuximab
antiretrovirals
human papilloma virus vaccine

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), colorectal carcinoma (CRC), cutaneous squamous cell carcinoma (cSCC), anal cell carcinoma (ASCC) and cervical cancer. The recommended phase 2 dose of NKTR-255, determined in the dose escalation phase (Phase 1b), will be used to treat patients in Phase 2 of this study.

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. The recommended phase 2 dose of NKTR-255 will be used to treat patients in Phase 2 of this study.

In the dose expansion phase (Phase 2), patients will be treated with NKTR-255 alone and together with cetuximab as follows: Cohort A - HNSCC; Cohort B - CRC; Cohort C - cSCC; Cohort D - ASCC; Cohort E - Cervical Cancer.

Patients who achieve optimal response will be given the option to continue treatment with NKTR-255 as single agent for maintenance.

Details
Condition Head and Neck Squamous Cell Carcinoma, Colorectal Cancer, Cutaneous Squamous Cell Carcinoma, Anal Squamous Cell Carcinoma, Cervical Cancer
Treatment Cetuximab, NKTR-255
Clinical Study IdentifierNCT04616196
SponsorNektar Therapeutics
Last Modified on26 April 2022

Eligibility

 Yes No Not Sure

Inclusion Criteria

Histologically confirmed diagnosis of a locally advanced or metastatic HNSCC, CRC, cSCC, ASCC, or cervical cancer
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
cSCC
Patients must have received prior therapy including anti-PD-1 and platinum-based chemotherapy, have documented platinum-refractory disease, or be ineligible/unfit for platinum-based therapy
aSCC
Patients must have received prior therapy including anti-PD-1 and platinum-based chemotherapy, have documented platinum-refractory disease, or be ineligible/unfit for platinum-based therapy
If human immunodeficiency virus (HIV)-positive, patients must also have CD4+ count ≥ 300/μL, undetectable viral load, and be receiving highly active antiretroviral therapy at the time of screening
Cervical Cancer
Patients must have experienced progression (or toxicity precluding additional treatment) on any first- or second-line platinum-based chemotherapy and anti-PD-(L)1, have documented platinum-refractory disease, or be ineligible/unfit for platinum-based therapy
Patients must have known status by pathology for HPV

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
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