Interventional Study of INCB 99280 With Ipilimumab in Participants With Select Solid Tumors

Part of paid clinical trials in Los Angeles, California.

Sponsor
Incyte Corporation
Study ID
NCT05909995
Phase
PHASE1
Status
Terminated

Conditions

  • Colorectal Carcinoma (CRC)
  • Hepatocellular Carcinoma (HCC)
  • Melanoma
  • Microsatellite Instability - High (MSI-H)
  • Mismatch Repair Deficient (dMMR)
  • Renal Cell Carcinoma (RCC)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

The purpose of this study is to characterize the safety, tolerability, PK, and efficacy of INCB 99280 in combination with ipilimumab in participants with select solid tumors.

Key Dates

Start date
Aug 29, 2023
Status verified
Feb 2025
Primary completion
Sep 19, 2024
Completion
Nov 11, 2024

Study Design

Enrollment
8 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Escalation
    * Participants with RCC and MSI-H/dMMR CRC will receive 1 of two doses of INCB099280 BID with up to 4 doses of ipilimumab 1 mg/kg Q3 weeks * Participants with Melanoma and HCC will receive 1 of 2 doses of INCB099280 BID with up to 4 doses of 3 ipilimumab 3 mg/kg Q3 weeks
  • Experimental: Dose Expansion
    * Participants with RCC will receive 1 of two doses of INCB099280 BID with up to 4 doses of ipilimumab 1 mg/kg Q3 weeks of ipilimumab * Participants with HCC will receive 1 of two doses of INCB099280 BID with up to 4 doses of ipilimumab 3 mg/kg Q3 weeks of ipilimumab

Primary Outcome Measure

Occurence of DLTs [ Time Frame: 2 Years ]

Locations (5)

FacilityCityStateZIPSite coordinators
Valkyrie Clinical TrialsLos AngelesCalifornia90067-
UC Irvine Medical CenterOrangeCalifornia92868-
Sharp Memorial HospitalSan DiegoCalifornia92123-
Henry Ford Health SystemDetroitMichigan48202-
Alliance For Multispecialty Research LlcKnoxvilleTennessee37920-

Find similar trials in Los Angeles, CA

By condition
Melanoma
By specialty
OncologySkin cancerDermatology
By research site
Valkyrie Clinical Trials· Los Angeles, CAUC Irvine Medical Center· Orange, CASharp Memorial Hospital· San Diego, CAHenry Ford Health System· Detroit, MIAlliance For Multispecialty Research Llc· Knoxville, TN

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