Advanced/Metastatic
A Study of INCB099280 in Combination With Adagrasib in Adults With Advanced Solid Tumors Harboring a KRASG12C Mutation
Incyte Study ID:
INCB99280-204
CT.gov ID:
Eudra ID:
N/A
Sponsor:
Incyte Corporation
Collaborator:
Mirati Therapeutics Inc.
Study Contact Information:
Clinical Study Purpose
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.
Clinical Study Summary
MEDICAL CONDITION(S)
PRODUCT
COLLABORATORS
Mirati Therapeutics Inc.
DATE
Dec 2023 - Nov 2025
TYPE
Interventional
PHASE
Phase 1
SEX
Female & Male
AGE
18+ years
ACCEPTS HEALTHY VOLUNTEERS
No
Clinical Study Locations
Location
Status
Location
FONDAZIONE DEL PIEMONTE PER L ONCOLOGIA IRCC CANDIOLO
CANDIOLO, Italy, 10060
Status
Recruiting
Location
IRCCS ISTITUTO CLINICO HUMANITAS
ROZZANO, Italy, 20089
Status
Recruiting
Location
CENTRO RICERCHE CLINICHE DI VERONA (CRC)
VERONA, Italy, 37124
Status
Recruiting
Location
HOSPITAL GENERAL UNIVERSITARIO VALL D HEBRON
BARCELONA, Spain, 08035
Status
Recruiting
Location
HOSPITAL HM NOU DELFOS
BARCELONA, Spain, 08023
Status
Recruiting
Location
HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID
POZUELO DE ALARCON, Spain, 28223
Status
Recruiting
Key Inclusion and Exclusion Criteria
Inclusion Criteria
- KRASG12C-mutated solid malignancy determined by a sponsor-approved assay using either tumor tissue or ctDNA.
- Histologically confirmed malignant solid tumor with locally advanced and/or metastatic disease.
Exclusion Criteria
- Known additional malignancy that is progressing or requires active treatment.
- Central nervous system (CNS) metastases requiring treatment and/or leptomeningeal disease.
Protocol Summary
Incyte Study ID:
INCB99280-204
Primary Purpose:
Treatment
Allocation:
Randomized
Study Design:
Sequential Assignment
Masking:
None (Open Label)
Interventions:
Drug
Enrollment:
6
Primary Outcome
Open
Part 1: Number of participants with Dose Limiting Toxicities (DLTs)
Timeframe: Up to 28 days
Number of participants with Treatment-emergent Adverse Events (TEAEs)
Timeframe: Up to 2 years and 90 days
Number of participants with TEAEs leading to dose modification or discontinuation
Timeframe: Up to 2 years and 90 days
Secondary Outcome
Open
INCB099280 and adagrasib plasma concentrations.
Timeframe: Up to 2 years
Objective response rate (ORR)
Timeframe: Up to 2 years
Disease Control Rate (DCR)
Timeframe: Up to 2 years
Duration of Response (DOR)
Timeframe: Up to 2 years
Progression-free survival (PFS)
Timeframe: Up to 12 months