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

NCT ID: NCT05909995

Last Updated: 2025-02-18

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-29
• Study Completion Date: 2024-11-11

Brief Summary

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.

Conditions

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

INCB 99280 with Ipilimumab

Intervention Type: DRUG

Dose Escalation and expansion of INCB 99280 with Ipilimumab

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

Group Type: EXPERIMENTAL

INCB 99280 with Ipilimumab

Intervention Type: DRUG

Dose Escalation and expansion of INCB 99280 with Ipilimumab

Interventions

INCB 99280 with Ipilimumab

Dose Escalation and expansion of INCB 99280 with Ipilimumab

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Prior systemic therapy, diagnoses and disease setting as follows:

• For Part 1 (dose escalation), and no history of treatment with anti-CTLA-4 or anti-PD-(L)1 therapy and one of the following,

• Unresectable or metastatic cutaneous melanoma, or
• Unresectable of metastatic Child-Pugh Class A NDD not eligible for surgical and/or locoregional therapy, or
• Intermediate or poor-risk advanced clear cell RCC, or
• MSI-H or dMMR metastatic CRC and able to provide fresh or archival tumor tissue for central confirmation of MSI-H or dMMR.
• For Part 2 (dose expansion), IO treatment -naïve, e.g., no prior receipt of an anti PD-1, anti-PD-L1 or PD-L1, anti-CTLA-4, GITR, LAG3, TIM3, OX-40, IL-2, 4-1BB or other immune modulator, and have not received prior systemic therapy and one of the following,

• Unresectable or metastatic Child-Pugh Class A HCC not eligible for surgical and/or locoregional therapy, or
• Intermediate - or poor-risk advanced clear cell RCC.
• ECOG performance score of 0 or 1.
• Life expectancy > 3 months, in the opinion of the investigator.
• Histologically confirmed solid tumors with measurable disease per RECIST v1.1.

• Exception: HCC may be diagnoses based on cross-sectional multiphasic imagining using the AASLD criteria.
• Willingness to avoid pregnancy or fathering children.

Exclusion Criteria

• Known history of an additional malignancy.
• Central nervous system (CNS) metastases requiring treatment and/or leptomeningeal disease.
• Toxicity from prior therapy that has not recovered.
• Received thoracic radiation within 6 months of the first dose of study treatment.
• Participation in another interventional clinical study while receiving INCB099280.
• Impaired cardiac function of clinically significant cardiac disease.
• History of evidence of interstitial lung disease including non-infections pneumonitis.
• Presence of gastrointestinal condition that may affect drug absorption
• Any autoimmune disease requiring systemic treatment in the past 5 years.
• Diagnosis of immunodeficiency or receiving chronic systemic steroid therapy at a daily dose exceeding 10 mg of prednisone or equivalent
• Active infection requiring systemic therapy.
• History of organ transplantation, including allogeneic stem cell transplantation.
• Receipt of system antibiotics within 28 days of first dose of study treatment.
• Probiotic usage is prohibited during the screening and throughout the study treatment period.
• Received a live vaccine within 28 days of planned start of study drug.
• Laboratory values outside the Protocol-defined ranges.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Incyte Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Valkyrie Clinical Trials

Los Angeles, California, United States

UC Irvine Medical Center

Orange, California, United States

Sharp Memorial Hospital

San Diego, California, United States

Henry Ford Health System

Detroit, Michigan, United States

Alliance For Multispecialty Research Llc

Knoxville, Tennessee, United States

Princess Margaret Cancer Center

Toronto, Ontario, Canada

Johese Clinical Research: Midstream

Centurion, , South Africa

Mary Potter Oncology Centre

Pretoria, , South Africa

Countries

United States; Canada; South Africa

Other Identifiers

2023-503243-34-00

Identifier Type: REGISTRY

Identifier Source: secondary_id

INCB 99280-205

Identifier Type: -

Identifier Source: org_study_id