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

Melanoma Clinical Trial

Official title:

A Phase 1 Study of INCB099280 in Combination With Ipilimumab in Participants With Select Solid Tumors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05909995
• Other study ID #: INCB 99280-205
• Secondary ID: 2023-503243-34-0
• Status: Recruiting
• Phase: Phase 1
• Start date: August 29, 2023
• Est. completion date: July 27, 2026

Study information

• Verified date: May 2024
• Source: Incyte Corporation
• Contact: Incyte Corporation Call Center (US)
• Phone: 1.855.463.3463
• Email: medinfo[@]incyte.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: July 27, 2026
• Est. primary completion date: June 27, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell
• Colorectal Carcinoma (CRC)
• Colorectal Neoplasms
• Hepatocellular Carcinoma (HCC)
• Melanoma
• Microsatellite Instability
• Renal Cell Carcinoma (RCC)

Intervention

Drug:
• INCB 99280 with Ipilimumab
Dose Escalation and expansion of INCB 99280 with Ipilimumab

Locations

Country	Name	City	State
Canada	McGill University Health Centre/Glen Site/Cedars Cancer Centre	Montreal	Quebec
Canada	Princess Margaret Cancer Center	Toronto	Ontario
Mexico	Hospital Civil de Guadalajara Fray Antonio Alcalde	Guadalajara
South Africa	Johese Clinical Research: Midstream	Centurion
South Africa	Mary Potter Oncology Centre	Pretoria
United States	University of North Carolina At Chapel Hill	Chapel Hill	North Carolina
United States	Henry Ford Health System	Detroit	Michigan
United States	Alliance For Multispecialty Research Llc	Knoxville	Tennessee
United States	Valkyrie Clinical Trials	Los Angeles	California
United States	UC Irvine Medical Center	Orange	California
United States	Sharp Memorial Hospital	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Incyte Corporation

Countries where clinical trial is conducted

United States,  Canada,  Mexico,  South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurence of DLTs		2 Years
Primary	Incidence of TEAEs	Assessed by physical examinations, changes in vital signs and ECGs, and analysis of clinical laboratory samples.	2 Years
Primary	Incidence of TEAEs leading to dose interruption, dose reduction, or discontinuation of either of the study drugs		2 Years
Secondary	Concentration of INCB099280 in plasma		2 Years
Secondary	Objective response	Defined as having a best overall response of complete response or partial response by investigator assessment per RECIST v1.1.	2 Years
Secondary	Disease control	Defined as having a best overall response of complete response or partial response, or stable disease of = 15 weeks after initiation of study treatment, by investigator assessment per RECIST v1.1.	2 Years
Secondary	Duration of Response	Defined as the time from the earliest date of CR or PR until the earliest date of disease progression (by investigator assessment per RECIST v1.1) or death due to any cause if occurring sooner than progression.	2 Years