A Study of INCB099280 in Combination With Adagrasib in Adults With Advanced Solid Tumors Harboring a KRASG12C Mutation

Part of paid clinical trials in Los Angeles, California.

Sponsor
Incyte Corporation
Study ID
NCT06039384
Phase
PHASE1
Status
Terminated

Conditions

  • Advanced Solid Tumors

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • INCB099280 — DRUG
    Administered as specified in the treatment arm description
  • adagrasib — DRUG
    Administered as specified in the treatment arm description

Study Details

The purpose of this study is to evaluate the safety and tolerability of INCB099280 in combination with adagrasib and to establish the MTD or identify RDE(s) for the combination of INCB099280 and adagrasib.

Key Dates

Start date
Dec 28, 2023
Status verified
Jul 2025
Primary completion
Apr 11, 2025
Completion
Jul 11, 2025

Study Design

Enrollment
6 participants (actual)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1: Dose Finding
    INCB099280 administered in combination with adagrasib in participants with previously treated KRAS glutamine to cysteine mutation at codon 12 (KRASG12C) mutant advanced solid tumors, will be evaluated to identify dose(s) for further evaluation in the dose expansion phase of the study.
  • Experimental: Part 2: Dose Expansion
    Up to 80 participants will be enrolled in 1 of 2 disease-specific cohorts: Cohort A: previously treated KRASG12C mutated non-small cell lung cancer (NSCLC) Cohort B: previously treated KRASG12C-mutated colorectal cancer (CRC). Up to 3 doses may be selected from Part 1: Dose Finding for the Part 2: Dose Expansion.

Primary Outcome Measure

Part 1: Number of participants with Dose Limiting Toxicities (DLTs) [ Time Frame: Up to 28 days ]

Locations (5)

FacilityCityStateZIPSite coordinators
Valkyrie Clinical TrialsLos AngelesCalifornia90067-
Banner Md Anderson Cancer CenterGreeleyColorado80631-
Henry Ford Health SystemDetroitMichigan48202-
Mary Crowley Cancer Research Centers McCrc HeadquartersDallasTexas75251-
Inova Schar Cancer InstituteFalls ChurchVirginia22042-

Find similar trials in Los Angeles, CA

By research site
Valkyrie Clinical Trials· Los Angeles, CABanner Md Anderson Cancer Center· Greeley, COHenry Ford Health System· Detroit, MIMary Crowley Cancer Research Centers McCrc Headquarters· Dallas, TXInova Schar Cancer Institute· Falls Church, VA

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