Study of NKTR 255 in Combination With Cetuximab in Solid Tumors

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-30

Study Completion Date

2023-03-30

Brief Summary

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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).

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Detailed Description

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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

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Head and Neck Squamous Cell Carcinoma Colorectal Cancer

Study Design

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Allocation Method

NA

Intervention Model

SEQUENTIAL

Phase 1: Dose escalation cohorts will be sequential

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Dose Escalation of NKTR-255 with Cetuximab

Establish RP2D, of NKTR-255 with cetuximab.

Group Type EXPERIMENTAL

NKTR-255

Intervention Type DRUG

NKTR-255 IV every 21 days

Cetuximab

Intervention Type DRUG

Cetuximab will be given at specified doses on specified days

Interventions

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NKTR-255

NKTR-255 IV every 21 days

Intervention Type DRUG

Cetuximab

Cetuximab will be given at specified doses on specified days

Intervention Type DRUG

Other Intervention Names

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Erbitux®

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No