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

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

NCT ID: NCT05909995

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

Conditions: Official terms:
Carcinoma
Carcinoma, Renal Cell
Colorectal Neoplasms
Microsatellite Instability
Ipilimumab

Study type: Interventional

Study phase: Phase 1

Overall status: Active, not recruiting

Study design:

Allocation: Non-Randomized

Intervention model: Sequential Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: INCB 99280 with Ipilimumab
Description: Dose Escalation and expansion of INCB 99280 with Ipilimumab
Arm group label: Dose Escalation
Arm group label: Dose Expansion

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.

Criteria for 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. Other protocol-defined Inclusion/Exclusion Criteria may apply.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Valkyrie Clinical Trials

Address:
City: Los Angeles
Zip: 90067
Country: United States

Facility:
Name: UC Irvine Medical Center

Address:
City: Orange
Zip: 92868
Country: United States

Facility:
Name: Sharp Memorial Hospital

Address:
City: San Diego
Zip: 92123
Country: United States

Facility:
Name: Henry Ford Health System

Address:
City: Detroit
Zip: 48202
Country: United States

Facility:
Name: Alliance For Multispecialty Research Llc

Address:
City: Knoxville
Zip: 37920
Country: United States

Facility:
Name: Princess Margaret Cancer Center

Address:
City: Toronto
Zip: M5G 2M9
Country: Canada

Facility:
Name: Johese Clinical Research: Midstream

Address:
City: Centurion
Zip: 01692
Country: South Africa

Facility:
Name: Mary Potter Oncology Centre

Address:
City: Pretoria
Zip: 00181
Country: South Africa

Start date: August 29, 2023

Completion date: July 27, 2026

Lead sponsor:
Agency: Incyte Corporation
Agency class: Industry

Source: Incyte Corporation

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05909995