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:
NCT06039384
Eudra ID:
N/A
EU CT Number:
2023-503223-26-00
Sponsor:
Incyte Corporation
Collaborator:
Mirati Therapeutics Inc.
Study Contact Information:
1.855.463.3463 or [email protected]
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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)
  • Advanced/Metastatic
    • PRODUCT
  • Drug: INCB099280
  • Drug: adagrasib
    • COLLABORATORS
    Mirati Therapeutics Inc.
    DATE
    Dec 2023 - Jul 2025
    TYPE
    Interventional
    PHASE
    Phase 1
    SEX
    Female & Male
    AGE
    18+ years
    ACCEPTS HEALTHY VOLUNTEERS
    No

    Clinical Study Locations

    Name
    Contact Us
    Name
    FONDAZIONE DEL PIEMONTE PER L ONCOLOGIA IRCC CANDIOLO
    CANDIOLO, Italy, 10060
    Name
    IRCCS ISTITUTO CLINICO HUMANITAS
    ROZZANO, Italy, 20089
    Name
    CENTRO RICERCHE CLINICHE DI VERONA (CRC)
    VERONA, Italy, 37124
    Name
    HOSPITAL GENERAL UNIVERSITARIO VALL D HEBRON
    BARCELONA, Spain, 08035
    Name
    HOSPITAL HM NOU DELFOS
    BARCELONA, Spain, 08023
    Name
    HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID
    POZUELO DE ALARCON, Spain, 28223
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    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.
    Requirements information
    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.
    • Only participants with NSCLC will be enrolled into Part 2 Cohort A.
    • Only participants with CRC will be enrolled into Part 2 Cohort B.
    • • Part 1: Disease progression on or after at least 1 prior systemic treatment.
    • • Part 2 (Cohort A - NSCLC): Received an anti–PD-(L)1—containing regimen and platinum based chemotherapy regimen either concurrently or sequentially
    • • Part 2 (Cohort B - CRC): Received at least 1 line of systemic therapy that includes the combination of fluoropyrimidine-based chemotherapy (in combination with oxaliplatin and/or irinotecan) and either a vascular endothelial growth factor–targeting monoclonal antibody or an anti–epidermal growth factor receptor monoclonal antibody (if RAS wild type). Participants with MSI-H/dMMR CRC must also have received a prior immune checkpoint inhibitor approved for this indication.
    • • Measurable disease according to RECIST v1.1.
    • • Eastern Cooperative Oncology Group performance status of 0 or 1.
    • • Estimated life expectancy > 3 months.
    • • Willingness to avoid pregnancy.
    Exclusion Criteria
    • • Known additional malignancy that is progressing or requires active treatment.
    • • Central nervous system (CNS) metastases requiring treatment and/or leptomeningeal disease.
    • • Part 2 only: Prior treatment with an approved or investigational agent targeting KRASG12C.
    • • Toxicity from prior therapy that has not recovered to protocol-defined limits.
    • • Received thoracic radiation of > 30 Gy within 6 months of the first dose of study treatment.
    • • Participation in another interventional clinical study.
    • • History or evidence of interstitial lung disease, including noninfectious pneumonitis.
    • • Presence of gastrointestinal condition that may affect drug absorption.
    • • Active autoimmune disease requiring systemic treatment, including corticosteroids exceeding a daily dose of 10 mg of prednisone or equivalent.
    • • Diagnosis of immunodeficiency or receiving chronic systemic steroid therapy exceeding a daily dose of 10 mg of prednisone or equivalent.
    • • Active infection requiring systemic therapy.
    • • History of organ transplantation, including allogeneic stem cell transplantation.
    • • Receipt of systemic antibiotics within 28 days of the first dose of study treatment.
    • • Probiotic usage is prohibited during screening and throughout the study treatment period.
    • • Received a live vaccine within 28 days of the planned start of study drug.
    • • Laboratory values outside the Protocol-defined ranges.
    • Other protocol-defined Inclusion/Exclusion Criteria may apply.

    Protocol Summary

    Incyte Study ID:
    INCB99280-204
    Primary Purpose:
    Treatment
    Allocation:
    Randomized
    Study Design:
    Sequential Assignment
    Masking:
    None (Open Label)
    Interventions:
  • Drug: INCB099280
  • Drug: adagrasib
    • 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