Advanced/Metastatic

A Study of INCB099280 in Combination With Axitinib in Adults With Advanced Solid Tumors

Incyte Study ID:
INCB99280-201
CT.gov ID:
NCT05949632
Eudra ID:
2022-003663-13
EU CT Number:
2023-510281-27-00
Sponsor:
Incyte Corporation
Collaborator:
N/A
Study Contact Information:
+800 00027423 or [email protected]
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Clinical Study Purpose

This study is being conducted to evaluate the safety and tolerability of INCB099280 in combination with axitinib and to assess the antitumor activity of INCB099280 in combination with axitinib. This study will only be open in the UK and EU.

Clinical Study Summary

MEDICAL CONDITION(S)
  • Advanced/Metastatic
    • PRODUCT
  • Drug: INCB099280
  • Drug: axitinib
    • COLLABORATORS
    N/A
    DATE
    Apr 2024 - Jun 2025
    TYPE
    Interventional
    PHASE
    Phase 1/Phase 2
    SEX
    Female only
    AGE
    18+ years
    ACCEPTS HEALTHY VOLUNTEERS
    No

    Clinical Study Locations

    Name
    Contact Us
    Name
    ORSZAGOS ONKOLOGIAI INTEZET
    BUDAPEST, Hungary, 01122
    Name
    ST BARTHOLOMEW’S HOSPITAL
    LONDON, United Kingdom, EC1A 7BE
    Name
    THE ROYAL MARSDEN NHS FOUNDATION TRUST - SUTTON
    SUTTON, United Kingdom, SM2 5PT
    Name
    ADDENBROOKES HOSPITAL
    CAMBRIDGE, United Kingdom, CB2 0QQ
    Name
    BEATSON WEST OF SCOTLAND CANCER CENTREWESTER
    GLASGOW, United Kingdom, G12 0YN
    Name
    GUYS HOSPITAL
    LONDON, United Kingdom, SE1 9RT
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    Key Inclusion and Exclusion Criteria

    Inclusion Criteria

    • Histologically confirmed advanced solid tumors (protocol-defined select solid tumors) with measurable lesions per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST v1.1) that are considered non-amenable to surgery or other curative treatments or procedures.
    • Must have disease progression on or after treatment with at least one prior systemic chemotherapy.

    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:
    INCB99280-201
    Primary Purpose:
    Treatment
    Allocation:
    Non-randomized
    Study Design:
    Parallel Assignment
    Masking:
    None (Open Label)
    Interventions:
  • Drug: INCB099280
  • Drug: axitinib
    • Enrollment:
    5
    Primary Outcome
    Open

    Part 1: Number of participants with Dose Limiting Toxicities (DLTs)

    Timeframe: Up to 21 days

    Part 1: Number of participants with Treatment-emergent Adverse Events (TEAEs)

    Timeframe: Up to 2 years and 90 days

    Part 1: Number of participants with TEAEs leading to dose modification

    Timeframe: Up to 2 years

    Part 2: Objective response rate (ORR)

    Timeframe: Up to 2 years

    Secondary Outcome
    Open

    Part 2: Number of participants with Treatment-emergent Adverse Events (TEAEs)

    Timeframe: Up to 2 years and 90 days

    Part 2: Number of participants with TEAEs leading to dose modification

    Timeframe: Up to 2 years

    Part 1: 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

    INCB099280 and axitinib plasma concentrations.

    Timeframe: Up to 2 years