Genitourinary & Gynecologic Cancer, Bladder Cancer, Non Small Cell Lung Cancer, Head and Neck Cancer, Breast Cancer, Prostate Cancer, Colorectal Cancer, Stomach or Esophageal Cancer, Liver Cancer, Pancreatic Cancer, Anal Cancer

INCB106385 alone or in combination with Immunotherapy in Advanced Solid Tumors

Incyte Study ID:
INCB 106385-102
CT.gov ID:
NCT04580485
View Results Summary
Eudra ID:
2020-002921-27
Sponsor:
Incyte Corporation
Collaborator:
N/A
Study Contact Information:
1.855.463.3463 or [email protected]
Study Complete
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Clinical Study Purpose

This is a multicenter, open-label, dose-escalation/dose-expansion Phase 1 clinical study to investigate the safety, tolerability, PK profile, pharmacodynamics, and preliminary clinical efficacy of INCB106385 when given as monotherapy or in combination with INCMGA00012 in participants with selected CD8 T-cell–positive advanced solid tumors including SCCHN, NSCLC, ovarian cancer, CRPC, TNBC, bladder cancer, and specified GI malignancies (defined as CRC, gastric/GEJ cancer, HCC, PDAC, or SCAC)

Clinical Study Summary

MEDICAL CONDITION(S)
  • Genitourinary & Gynecologic Cancer
  • Bladder Cancer
  • Non Small Cell Lung Cancer
  • Head and Neck Cancer
  • Breast Cancer
  • Prostate Cancer
  • Colorectal Cancer
  • Stomach or Esophageal Cancer
  • Liver Cancer
  • Pancreatic Cancer
  • Anal Cancer
    • PRODUCT
  • Drug: INCB106385
  • Drug: INCMGA00012
    • COLLABORATORS
    N/A
    DATE
    Feb 2021 - Jan 2024
    TYPE
    Interventional
    PHASE
    Phase 1
    SEX
    Female & Male
    AGE
    18+ years
    ACCEPTS HEALTHY VOLUNTEERS
    No

    Clinical Study Locations

    Name
    Contact Us
    Name
    MD ANDERSON CANCER CENTER
    HOUSTON, TX, US, 77030
    Name
    CEDARS-SINAI MEDICAL CENTER
    WEST HOLLYWOOD, CA, US, 90048
    Name
    UNIVERSITY OF PITTSBURGH
    PITTSBURGH, PA, US, 15232
    Name
    CLINICA UNIVERSIDAD DE NAVARRA (CUN)
    PAMPLONA, Spain, 31008
    Name
    DANA FARBER CANCER INSTITUTE
    BOSTON, MA, US, 02215
    Name
    HOSPITAL GENERAL UNIVERSITARIO VALL D HEBRON
    BARCELONA, Spain, 08035

    Key Inclusion and Exclusion Criteria

    Inclusion Criteria

    • Ability to comprehend and willingness to sign an ICF.
    • Willing and able to conform to and comply with all Protocol requirements.

    Exclusion Criteria

    • Clinically significant cardiac disease.
    • Known or active CNS metastases and/or carcinomatous meningitis.

    Protocol Summary

    Incyte Study ID:
    INCB 106385-102
    Primary Purpose:
    Treatment
    Allocation:
    Non-randomized
    Study Design:
    Parallel Assignment
    Masking:
    None (Open Label)
    Interventions:
    Drug
    Enrollment:
    54
    Primary Outcome
    Open

    Number of treatment-emergent adverse events (TEAE)

    Timeframe: Up to Approximately 28 months

    Secondary Outcome
    Open

    Cmax of INCB106385 as a single agent or in combination with INCMGA00012

    Timeframe: Up to 6 months

    Tmax of INCB106385 as a single agent or in combination with INCMGA00012

    Timeframe: Up to 6 months

    Cmin of INCB106385 as a single agent or in combination with INCMGA00012

    Timeframe: Up to 6 months

    AUC of INCB106385 as a single agent or in combination with INCMGA00012

    Timeframe: Up to 6 months

    CL/F of INCB106385 as a single agent or in combination with INCMGA00012

    Timeframe: Up to 6 months

    Objective Response Rate (ORR)

    Timeframe: Up to approximately 24 months

    Disease Control Rate

    Timeframe: Up to approximately 24 months

    Duration Of Response (DOR)

    Timeframe: Up to approximately 24 months

    Change in tumoral gene expression

    Timeframe: Predose and Week 5-6

    Change in immune cell activation in tumors

    Timeframe: Predose and Week 5-6