Advanced/Metastatic

Study of INCA32459 a LAG-3 and PD-1 bispecific antibody in Participants With Select Advanced Malignancies

Incyte Study ID:
INCA 32459-101
CT.gov ID:
NCT05577182
Eudra ID:
N/A
Sponsor:
Incyte Corporation
Collaborator:
N/A
Study Contact Information:
1.855.463.3463 or [email protected]
Recruitment Complete
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Clinical Study Purpose

This is a multicenter, open-label, single-arm study to investigate the safety, tolerability, PK, pharmacodynamics and preliminary activity of INCA32459 in participants with selected advanced malignancies. Part 1 (dose escalation) will determine the recommended dose of INCA 32459 for expansion (RDE) and the maximum tolerated dose (MTD). Part 2 (dose expansion) will further evaluate the safety, tolerability, PK, pharmacodynamics, and preliminary antitumor activity of INCA 32459 at the recommended dose(s) for expansion in 2 tumor-specific cohorts.

Clinical Study Summary

MEDICAL CONDITION(S)
  • Advanced/Metastatic
    • PRODUCT
  • Drug: INCA32459-101
    • COLLABORATORS
    N/A
    DATE
    Jan 2023 - Aug 2026
    TYPE
    Interventional
    PHASE
    Phase 1
    SEX
    Female & Male
    AGE
    18+ years
    ACCEPTS HEALTHY VOLUNTEERS
    No

    Key Inclusion and Exclusion Criteria

    Inclusion Criteria

    • Histologically or cytologically confirmed advanced malignancies as follows:
    • a. Part 1 only: Participants with the select advanced malignancies as specified in the protocol.

    Exclusion Criteria

    • Prior treatment with any LAG-3– or MHC Class II–directed therapy for current malignancy, or any prior malignancy.
    • Treatment with anticancer therapies or participation in another interventional clinical study within 28 days before the first administration of study treatment (this includes curative radiation to the thorax or systemic anticancer therapies).

    Clinical Study Locations

    Location
    Status
    Location
    UNIVERSITY OF TEXAS MD ANDERSON CANCER CENTER
    HOUSTON, TX, US, 77030
    Status
    Recruiting
    Location
    UNIVERSITAIR ZIEKENHUIS GENT
    GENT, Belgium, 09000
    Status
    Recruiting
    Location
    UNIVERSITAIR ZIEKENHUIS ANTWERPEN (UZA)
    EDEGEM, Belgium, 02650
    Status
    Not yet recruiting
    Location
    CHU UCL NAMUR UNIVERSITY HOSPITAL MONT-GODINNE
    YVOIR, Belgium, 05530
    Status
    Recruiting
    Location
    UNIVERSITAIR ZIEKENHUIS BRUSSEL
    JETTE, Belgium, 01090
    Status
    Recruiting
    Location
    CLINIQUES UNIVERSITAIRES UCL SAINT-LUC
    BRUXELLES, Belgium, 01200
    Status
    Recruiting

    Protocol Summary

    Incyte Study ID:
    INCA 32459-101
    Primary Purpose:
    Treatment
    Allocation:
    Non-randomized
    Study Design:
    Sequential Assignment
    Masking:
    None (Open Label)
    Interventions:
    Drug
    Enrollment:
    46
    Primary Outcome
    Open

    Part 1: Occurrence of Dose Limiting Toxicities (DLTs)

    Timeframe: Up to approximately 12 months

    Number of Participants With Treatment Emergent Adverse Events (TEAEs)

    Timeframe: Up to approximately 12 months

    Number of Participants with Dose Interruptions due to TEAE

    Timeframe: Up to approximately 12 months

    Number of Participants discontinue study due to TEAE

    Timeframe: Up to approximately 12 months

    Secondary Outcome
    Open

    Objective Response Rate (ORR)

    Timeframe: Up to 12 months

    Disease Control Response (DCR)

    Timeframe: Up to 12 months

    Duration of Response (DOR)

    Timeframe: Up to 12 months

    PK parameters: Cmax

    Timeframe: Up to 24 months

    PK parameters: tmax

    Timeframe: Up to 24 months

    PK parameters: Cmin

    Timeframe: Up to 24 months

    PK Parameters: AUC

    Timeframe: Up to 24 months

    PK Parameters: CL

    Timeframe: Up to 24 months

    PK Parameters: Vz

    Timeframe: Up to 24 months

    PK Parameters: t1/2

    Timeframe: Up to 24 months

    Receptor Occupancy

    Timeframe: Up to 24 months