NCT04616196

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Nektar Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Head and Neck Squamous Cell Carcinoma
• Colorectal Cancer

Interventions

Type	Name	Description
DRUG	NKTR-255	NKTR-255 IV every 21 days
DRUG	Cetuximab	Cetuximab will be given at specified doses on specified days

Timeline

• Start date: 2020-10-30
• Primary completion: 2023-03-30
• Completion: 2023-03-30
• First posted: 2020-11-04
• Last updated: 2025-06-08
• Results posted: 2025-06-08

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated drug study