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

NCT05909995 | Terminated Phase 1 FDA Drug

• 2 other identifiers: INCB 99280-2052023-503243-34-00
• Study Type: interventional
• Target: 8
• Locations: 3 countries
• Sites: 8

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)

Outcome Measures

Primary Outcomes (3)

• Occurence of DLTs

  2 Years

• Incidence of TEAEs

  Assessed by physical examinations, changes in vital signs and ECGs, and analysis of clinical laboratory samples.

  2 Years

• Incidence of TEAEs leading to dose interruption, dose reduction, or discontinuation of either of the study drugs

  2 Years

Secondary Outcomes (4)

• Concentration of INCB099280 in plasma

  2 Years

• Objective response

  2 Years

• Disease control

  2 Years

• Duration of Response

  2 Years

Study Arms (2)

Dose Escalation

EXPERIMENTAL

* 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

Drug: INCB 99280 with Ipilimumab

Dose Expansion

EXPERIMENTAL

* 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

Drug: INCB 99280 with Ipilimumab

Interventions

INCB 99280 with Ipilimumab DRUG

Dose Escalation and expansion of INCB 99280 with Ipilimumab

Dose Escalation; Dose Expansion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Incyte Corporation: lead

Study Sites (8)

Valkyrie Clinical Trials

Los Angeles, California, 90067, United States

Location

UC Irvine Medical Center

Orange, California, 92868, United States

Location

Sharp Memorial Hospital

San Diego, California, 92123, United States

Location

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

Alliance For Multispecialty Research Llc

Knoxville, Tennessee, 37920, United States

Location

Princess Margaret Cancer Center

Toronto, Ontario, M5G 2M9, Canada

Location

Johese Clinical Research: Midstream

Centurion, 01692, South Africa

Location

Mary Potter Oncology Centre

Pretoria, 00181, South Africa

Location

MeSH Terms

Conditions

Melanoma; Carcinoma, Hepatocellular; Carcinoma, Renal Cell; Turcot syndrome; Colorectal Neoplasms

Interventions

Ipilimumab

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Liver Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Liver Diseases; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2023
• First Posted: June 18, 2023
• Study Start: August 29, 2023
• Primary Completion: September 19, 2024
• Study Completion: November 11, 2024
• Last Updated: February 18, 2025

Record last verified: 2025-02

Locations

ZA (2); CA (1); US (5)