Advanced/Metastatic

A Study Exploring the Safety and Tolerability of INCB081776 in Participants With Advanced Malignancies

Incyte Study ID:
INCB 81776-101
CT.gov ID:
NCT03522142
Eudra ID:
N/A
Sponsor:
Incyte Corporation
Collaborator:
N/A
Study Contact Information:
1.855.463.3463 or [email protected]
Recruitment Complete
Subscribe to UpdatesContact Us

Clinical Study Purpose

The purpose of this study is to evaluate the safety and tolerability, pharmacokinetics, pharmacodynamics, and early clinical activity of single-agent INCB081776 (Part 1) and INCB081776 in combination with INCMGA00012 (Part 2).

Clinical Study Summary

MEDICAL CONDITION(S)
  • Advanced/Metastatic
    • PRODUCT
  • Drug: INCB081776
  • Drug: INCMGA00012
    • COLLABORATORS
    N/A
    DATE
    Aug 2018 - Apr 2025
    TYPE
    Interventional
    PHASE
    Phase 1
    SEX
    Female & Male
    AGE
    18+ years
    ACCEPTS HEALTHY VOLUNTEERS
    No

    Clinical Study Locations

    Location
    Status
    Location
    YALE CANCER CENTER
    NEW HAVEN, CT, US, 06510
    Status
    Recruiting
    Location
    MEMORIAL SLOAN KETTERING CANCER CENTER
    NEW YORK, NY, US, 10065
    Status
    Completed
    Location
    UNIVERSITY OF PENNSYLVANIA ABRAMSON CANCER CENTER
    PHILADELPHIA, PA, US, 19104
    Status
    Recruiting
    Location
    UNIVERSITY OF PITTSBURGH
    PITTSBURGH, PA, US, 15232
    Status
    Recruiting
    Location
    SARAH CANNON RESEARCH INSTITUTE
    NASHVILLE, TN, US, 37203
    Status
    Recruiting
    Location
    MD ANDERSON CANCER CENTER
    HOUSTON, TX, US, 77030
    Status
    Recruiting

    Key Inclusion and Exclusion Criteria

    Inclusion Criteria

    • Male and female participants at least 18 years of age with advanced malignancies who have received or been intolerant to standard therapy:
    • Parts 1A and 2A:

    Exclusion Criteria

    • Laboratory values not within the protocol-defined range.
    • History of retinal disease as defined in the protocol.

    Protocol Summary

    Incyte Study ID:
    INCB 81776-101
    Primary Purpose:
    Treatment
    Allocation:
    Non-randomized
    Study Design:
    Parallel Assignment
    Masking:
    None (Open Label)
    Interventions:
    Drug
    Enrollment:
    84
    Primary Outcome
    Open

    Part 1 (1A and 1B): Number of treatment-emergent adverse events (TEAEs)

    Timeframe: Screening through 90 days after end of treatment, up to approximately 1 year.

    Part 1 (1A and 1B): Recommended Dose for Expansion (RDE)

    Timeframe: Up to one year

    Part 2 (2A & 2B): Number of treatment-emergent adverse events

    Timeframe: Screening through 90 days after end of treatment, up to approximately 1 year

    Part 2 (2A & B): RDE in combination with INCMGA00012

    Timeframe: Up to one year

    Secondary Outcome
    Open

    Part 1 and Part 2: Cmax of INCB081776

    Timeframe: Up to approximately 3 weeks.

    Part 1 and Part 2: Tmax of INCB081776

    Timeframe: Up to approximately 3 weeks.

    Part 1 and Part 2: t½ of INCB081776

    Timeframe: Up to approximately 3 weeks.

    Part 1 and Part 2: Pharmacokinetic/ pharmacodynamic correlation

    Timeframe: Up to approximately 3 weeks.

    Part 1 and Part 2: Overall response rate

    Timeframe: Up to approximately 1 year.

    Part 1 and Part 2: Disease control rate

    Timeframe: Up to approximately 1 year.

    Part 1 and Part 2: Duration of response

    Timeframe: Up to approximately 1 year.

    Part 1 and Part 2: AUC0-t of INCB081776

    Timeframe: Up to approximately 3 weeks.

    Part 1 and Part 2: Cmin of INCB081776

    Timeframe: Up to approximately 3 weeks.

    Part 1 and Part 2: AUC0-∞ of INCB081776

    Timeframe: Up to approximately 3 weeks.

    Part 1 and Part 2 : CL/F of INCB081776

    Timeframe: Up to approximately 3 weeks.

    Part 1 and Part 2 : λz of INCB081776

    Timeframe: Up to approximately 3 weeks.

    Part 1 and Part 2 : Vz/F of INCB081776

    Timeframe: Up to approximately 3 weeks.