Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion

Description

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.

Official Title

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

Details

This study is a Phase 1b/2, open-label, multicenter dose escalation and dose expansion study in patients with R/R HNSCC or CRC. NKTR-255 is a cytokine that is designed to regulate T and natural killer cell activation, proliferation and promote their anti-tumor effects. After an initial cetuximab loading dose during the study run-in period (Day -7), patients will receive IV NKTR-255 every 21 days in combination with cetuximab weekly. In the dose escalation phase, beginning with Dose Level 1, successive cohorts will receive ascending doses of NKTR-255 until the MTD and/or RP2D is determined. Patients who achieve optimal response (partial response or complete response), will be given the option to continue treatment with NKTR-255 as single agent for maintenance. Enrollment into Phase 2 will commence once the RP2D is established in Phase 1b. The RP2D of NKTR-255 will be evaluated in expansion Cohorts A and B. Cohort A will combine NKTR-255 and cetuximab in patients with R/R HNSCC and Cohort B will combine NKTR-255 and cetuximab in patients with R/R CRC.

Keywords

Head and Neck Squamous Cell Carcinoma (HNSCC) Colorectal Cancer (CRC) HNSCC CRC R/R NKTR-255 Cetuximab Squamous Cell Carcinoma of Head and Neck

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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.

You CAN'T join 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
  • Contraindication to or unable to receive cetuximab

Locations

  • UC San Francisco not yet accepting patients
    San Francisco California 94158 United States
  • UC San Diego not yet accepting patients
    San Diego California 92103 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Nektar Therapeutics
ID
NCT04616196
Phase
Phase 1/2
Study Type
Interventional
Last Updated