Clinical trial NCT04616196: Study of NKTR 255 in Combination With Cetuximab in Solid Tumors
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Head and Neck Squamous Cell Carcinoma
Colorectal Cancer
Keywords: HNSCC
Head and Neck Squamous Cell Carcinoma
CRC
Colorectal Cancer
NKTR-255
Cetuximab
Erbitux®
Lead sponsor: Nektar Therapeutics
Sponsor class: INDUSTRY
First posted: 2020-11-04
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Intervention model description: Phase 1: Dose escalation cohorts will be sequential
Primary purpose: TREATMENT

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).

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.

Eligibility criteria: Key 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.

Key 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

Primary outcomes:
measure: 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
timeFrame: 60 days after the last dose of study treatment, up to an average of 6 months.
measure: 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
timeFrame: Up to 21 days
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: University of California, San Diego
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Dallas
country: United States
facility: Mary Crowley Cancer Research
state: Texas
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
city: San Antonio
country: United States
facility: START Center for Cancer Care
state: Texas
Study officials:
affiliation: Nektar Therapeutics
name: Study Director
role: STUDY_DIRECTOR
References: