Study of INCA 0186 in Subjects With Advanced Solid Tumors

Part of paid clinical trials in Los Angeles, California.

Sponsor
Incyte Corporation
Study ID
NCT04989387
Phase
PHASE1
Status
Terminated

Conditions

  • Advanced Solid Tumors
  • Gastrointestinal (GI) Malignancies
  • Squamous Cell Carcinoma of the Head and Neck (SCCHN)

Eligibility Criteria

Sex
ALL
Age
18 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • INCA00186 — DRUG
    INCA00186 will be administered every 2 weeks or 4 weeks as per protocol
  • Retifanlimab — DRUG
    Retifanlimab will be administered every 4 weeks as per protocol
  • INCB106385 — DRUG
    INCB106385 will be administered orally once or twice a day.

Study Details

This is an open-label, nonrandomized, multicenter, dose escalation, and dose expansion first-in human (FIH) Phase 1 study to determine the safety, tolerability, PK, pharmacodynamics, and preliminary efficacy of INCA00186 when given alone or in combination with INCB106385 and/or retifanlimab in participants with specific advanced solid tumors; squamous cell carcinoma of the head and neck (SCCHN) and specified gastrointestinal (GI) malignancies have been selected as indications of interest for this study. Participants with CD8 T-cell-positive tumors will be selected as these tumors are more likely to respond to immunotherapy.

Key Dates

Start date
Oct 4, 2021
Status verified
Aug 2025
Primary completion
Sep 19, 2024
Completion
Sep 19, 2024

Study Design

Enrollment
57 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment Group A Dose Escalation and Expansion
    INCA00186 will be administered as monotherapy every 2 or every 4 weeks.
  • Experimental: Treatment Group B1 Dose Escalation and Expansion
    INCA00186 will be administered in combination with retifanlimab. INCA00186 will be administered every 2 or 4 weeks and retifanlimab will be administered every 4 weeks.
  • Experimental: Treatment Group B2 Dose Escalation and Expansion
    INCA00186 will be administered in combination with INCB106385. INCA00186 will be administered every 2 or 4 weeks and INCB106385 will be administered once or twice daily.
  • Experimental: Treatment Group C Dose Escalation and Expansion
    INCA00186 will be administered in combination with retifanlimab and INCB106385. INCA00186 will be administered every 2 to 4 weeks, retifanlimab every 4 weeks and INCB106385 once or twice daily.

Primary Outcome Measure

Evaluation of the safety and tolerability of INCA00186 as monotherapy and in combination with retifanlimab and/or INCB106385 as measured by the number of participants with adverse eventsductions and withdrawal of treatment due to AEs [ Time Frame: 90 days after study completion totaling up to 27 months ]

Locations (8)

FacilityCityStateZIPSite coordinators
The Angeles Clinic and Research InstituteLos AngelesCalifornia90025-
Emory UniversityAtlantaGeorgia30322-
University of Maryland-Greenebaum Cancer CenterBaltimoreMaryland21201-
Hackensack University Medical CenterHackensackNew Jersey07601-
Carolina Bio-Oncology Institute, PllcHuntersvilleNorth Carolina28078-
Vanderbilt Medical CenterNashvilleTennessee37232-
Md Anderson Cancer CenterHoustonTexas77030-
South Texas Accelerated Research TherapeuticsSan AntonioTexas78229-

Find similar trials in Los Angeles, CA

By research site
The Angeles Clinic and Research Institute· Los Angeles, CAEmory University· Atlanta, GAUniversity of Maryland-Greenebaum Cancer Center· Baltimore, MDHackensack University Medical Center· Hackensack, NJCarolina Bio-Oncology Institute, Pllc· Huntersville, NCVanderbilt Medical Center· Nashville, TN

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