Advanced/Metastatic

Study of INCB123667 in Subjects with Advanced Solid Tumors

Incyte Study ID:
INCB 123667-101
CT.gov ID:
NCT05238922>
Eudra ID:
N/A
Sponsor:
Incyte Corporation
Collaborator:
N/A
Study Contact Information:
1.855.463.3463 or [email protected]
Recruiting
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Clinical Study Purpose

This is an open-label, dose-escalation and dose-expansion study to determine the safety, tolerability, PK, pharmacodynamics, and preliminary efficacy of INCB123667 when administered as monotherapy and in combination with anticancer therapies in participants with selected advanced or metastatic solid tumors. This study will consist of 2 parts. In Part 1, INCB123667 will be administered as monotherapy and in Part 2, INCB123667 will be administered in combination with anticancer therapies of interest. Each part will comprise a dose escalation portion (Parts 1a and 2a, respectively) and a dose-expansion portion (Parts 1b and 2b, respectively).

Clinical Study Summary

MEDICAL CONDITION(S)
  • Advanced/Metastatic
    • PRODUCT
  • Drug: INCB0123667
  • Drug: Palbociclib
  • Drug: Bevacizumab
  • Drug: Olaparib
  • Drug: Paclitaxel
  • Drug: Ribociclib
  • Drug: Fulvestrant
    • COLLABORATORS
    N/A
    DATE
    Jul 2022 - Aug 2025
    TYPE
    Interventional
    PHASE
    Phase 1
    SEX
    Female & Male
    AGE
    18+ years
    ACCEPTS HEALTHY VOLUNTEERS
    No

    Clinical Study Locations

    Location
    Status
    Location
    ONCOLOGICAL INSTITUTE OF SOUTHERN SWITZERLAND
    BELLINZONA, Switzerland, 6500
    Status
    Recruiting
    Location
    INSELSPITAL UNIVERSITATSKLINIK FUR MEDIZINISCHE ONKOLOGIE
    BERN, Switzerland, 3010
    Status
    Recruiting
    Location
    UNIVERSITAIRE DU CANCER DE TOULOUSE INSTITUT CLAUDIUS REGAUD IUCT-ONCOPOLE
    TOULOUSE, France, 31059
    Status
    Recruiting
    Location
    CENTRE LEON BERARD
    LYON, France, 69373
    Status
    Recruiting
    Location
    INSTITUT GUSTAVE ROUSSY
    VILLEJUIF CEDEX, France, 94805
    Status
    Recruiting
    Location
    INSTITUT BERGONIE
    BORDEAUX, France, 33076
    Status
    Recruiting

    Key Inclusion and Exclusion Criteria

    Inclusion Criteria

    • Adults aged 18 years or older at the time of the signing of the ICF.
    • Life expectancy greater than 12 weeks.

    Exclusion Criteria

    • History of clinically significant or uncontrolled cardiac disease.
    • History or presence of an ECG abnormality that, in the investigator's opinion, is clinically meaningful.

    Protocol Summary

    Incyte Study ID:
    INCB 123667-101
    Primary Purpose:
    Treatment
    Allocation:
    Non-randomized
    Study Design:
    Sequential Assignment
    Masking:
    None (Open Label)
    Interventions:
    Drug
    Enrollment:
    604
    Primary Outcome
    Open

    Part 1A : Occurrence of Dose Limiting Toxicities (DLTs)

    Timeframe: Up to Day 28

    Number of Participants With Treatment Emergent Adverse Events (TEAEs)

    Timeframe: Up to 12 months

    Number of Participants with Dose Interruptions due to TEAE

    Timeframe: Up to 12 months

    Number of Participants who Undergo Dose Reductions due to TEAE

    Timeframe: Up to 12 months

    Number of Participants Discontinue study due to TEAE

    Timeframe: Up to 12 months

    Secondary Outcome
    Open

    PK parameters: Cmax

    Timeframe: Cycle 1 Days 1, 2, 8 and 9; Cycle 2 Day 1; Cycles 3 through 9 Day 1 (each cycle is 28 days)

    PK parameters: tmax

    Timeframe: Cycle 1 Days 1, 2, 8 and 9; Cycle 2 Day 1; Cycles 3 through 9 Day 1 (each cycle is 28 days)

    PK parameters: Ctau

    Timeframe: Cycle 1 Days 1, 2, 8 and 9; Cycle 2 Day 1; Cycles 3 through 9 Day 1 (each cycle is 28 days)

    PK Parameters: AUC

    Timeframe: Cycle 1 Days 1, 2, 8 and 9; Cycle 2 Day 1; Cycles 3 through 9 Day 1 (each cycle is 28 days)

    PK Parameters: CL/F

    Timeframe: Cycle 1 Days 1, 2, 8 and 9; Cycle 2 Day 1; Cycles 3 through 9 Day 1 (each cycle is 28 days)

    PK Parameters: Vz/F

    Timeframe: Cycle 1 Days 1, 2, 8 and 9; Cycle 2 Day 1; Cycles 3 through 9 Day 1 (each cycle is 28 days)

    PK Parameters: t1/2

    Timeframe: Cycle 1 Days 1, 2, 8 and 9; Cycle 2 Day 1; Cycles 3 through 9 Day 1 (each cycle is 28 days)

    Objective Response Rate (ORR)

    Timeframe: Up to 12 months

    Disease Control

    Timeframe: Up to 12 months

    Duration of Response (DOR)

    Timeframe: Up to 12 months