A Study to Evaluate INCB099280 in Participants With Select Solid Tumors Who Are Immune Checkpoint Inhibitor Naive

NCT05879822 | Active Not Recruiting Phase 2 FDA Drug

• 2 other identifiers: INCB 99280-2112022-502716-37-00
• Study Type: interventional
• Target: 73
• Locations: 9 countries
• Sites: 54

Brief Summary

This study is being conducted to determine the safety, tolerability, and preliminary efficacy of INCB099280 in participants with advanced solid tumors.

Conditions

Advanced Solid Tumor

Keywords

Advanced Solid Tumor; Hepatocellular Carcinoma; Cutaneous Melanoma; PD-L1-positive NSCLC; Non-small Cell Lung Cancer; Renal Cell Carcinoma; Urothelial Cancer; MSI-H/dMMR Tumors

Outcome Measures

Primary Outcomes (3)

• Objective response rate (ORR)

  Defined as the percentage of participants with a best overall response of complete response (CR) or partial response (PR), as determined by investigator radiographic disease assessment according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

  Up to 2 years

• Number of participants with Treatment-emergent Adverse Events (TEAEs)

  Defined as any Adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug up to 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurs first.

  Up to 2 years 3 months

• Number of participants with TEAEs leading to dose modification or discontinuation

  Number of participants with TEAEs leading to dose modification or discontinuation.

  Up to 2 years

Secondary Outcomes (3)

• Disease Control Rate (DCR)

  Up to 2 years

• Duration Of Response (DOR)

  Up to 2 years

• INCB099280 pharmacokinetic (PK) in Plasma

  Pre dose and 1, 2 and 6 hours post dose on Cycle 1 Day 1 and Cycle 2 Day 1. Pre dose every other cycle until Cycle 11 Day 1 (Cycle 3 Day 1, Cycle 5 Day 1, Cycle 7 Day 1, Cycle 9 Day 1 and Cycle 11 Day 1) (each cycle is 28 days)

Study Arms (4)

Part 1: INCB099280 Dose 1

EXPERIMENTAL

Participants will receive INCB099280 dose 1 twice daily (BID) for up to 2 years.

Drug: INCB099280

Part 1: INCB099280 Dose 2

EXPERIMENTAL

Participants will receive INCB099280 dose 2 twice daily (BID) for up to 2 years.

Drug: INCB099280

Part 1: INCB099280 Dose 3

EXPERIMENTAL

Participants will receive INCB099280 dose 3 twice daily (BID) for up to 2 years

Drug: INCB099280

Part 2: INCB099280 Dose selected from Part 1

EXPERIMENTAL

Participants will receive INCB099280 dose selected from Part 1 twice daily (BID) for up to 2 years.

Drug: INCB099280

Interventions

INCB099280 DRUG

Administered as specified in the treatment arm description

Part 1: INCB099280 Dose 1; Part 1: INCB099280 Dose 2; Part 1: INCB099280 Dose 3; Part 2: INCB099280 Dose selected from Part 1

Eligibility Criteria

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

You may qualify if:

• Immunotherapy naive and without access to approved and/or available immune checkpoint inhibitor (ICI) therapy.
• Measurable disease per RECIST v1.1.
• One of the following disease settings:
• Unresectable or metastatic Child-Pugh Class A hepatocellular carcinoma (HCC) not eligible for surgical and/or locoregional therapy and have not received prior systemic therapy or had disease progression following primary therapy.
• Unresectable or metastatic cutaneous melanoma and have not received more than 1 previous systemic therapy for advanced disease.
• Unresectable Stage III PD-L1-positive (TPS ≥ 50% using the Dako PD-L1 IHC 22C3 assay) non-small cell lung cancer (NSCLC) without actionable molecular biomarkers and have not received prior systemic therapy and where chemoradiation is contraindicated; in addition, able to provide fresh or archival tumor tissue for central confirmation of PD-L1 expression.
• Stage IV PD-L1-positive (TPS ≥ 50% using the Dako PD-L1 IHC 22C3 assay) NSCLC without actionable molecular biomarkers and have not received prior systemic therapy; in addition, able to provide fresh or archival tumor tissue for central confirmation of PD-L1 expression.
• Relapsed or Stage IV clear cell renal cell carcinoma (RCC) after having received 1 prior systemic therapy for relapsed or Stage IV disease.
• Cisplatin-ineligible, locally advanced or Stage IV urothelial cancer (UC) and have not received prior systemic therapy for locally advanced or Stage IV UC and able to provide fresh or archival tumor tissue for central confirmation of PD-L1 expression using the Dako PD-L1 IHC 22C3 assay.
• Advanced or metastatic microsatellite instability high (MSI-H) or deficient mismatch repair (dMMR) (as determined by an approved assay) solid tumors and able to provide fresh or archival tumor tissue for central confirmation of MSI-H or dMMR.
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
• Life expectancy \> 3 months.
• 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.
• Prior receipt of an PD-1, anti-PD-L1, or anti-PD-L2 agent or treatment with an immune modulator (eg, CTLA-4, GITR, LAG3, TIM3, OX40, ICOS, IL-2, 4-1BB, CAR-T cell).
• 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 or clinically significant cardiac disease.
• History or evidence of interstitial lung disease including noninfectious pneumonitis.
• Presence of gastrointestinal conditions 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 systemic antibiotics within 28 days of first dose of study treatment.
• Probiotic usage is prohibited during screening and throughout the study treatment period.

Sponsors & Collaborators

• Incyte Corporation: lead

Study Sites (54)

Fundacao Pio Xii Hospital de Cancer de Barretos

Barretos, 14784-400, Brazil

Location

Cionc-Centro Integrado de Oncologia de Curitiba

Curitiba, 80810-050, Brazil

Location

Hospital Erasto Gaertner - Liga Paranaense de Combate Ao Câncer

Curitiba, 81520-060, Brazil

Location

Oncosite - Centro de Pesquisa Clinica E Oncologia

Ijuí, 98700-000, Brazil

Location

Clinica de Neoplasias Litoral Ltda

Itajaí, 88301-220, Brazil

Location

Fundacao Doutor Amaral Carvalho

Jaú, 17210-120, Brazil

Location

Hospital de Cancer de Londrina

Londrina, 86015-520, Brazil

Location

Irmandade Da Santa Casa de Misericordia de Porto Alegre

Porto Alegre, 90020-090, Brazil

Location

Hgb - Hospital Giovanni Battista - Mae de Deus Center

Porto Alegre, 90110-270, Brazil

Location

Hospital Ernesto Dornelles

Porto Alegre, 90160-093, Brazil

Location

Hospital Nossa Senhora Da Conceicao

Porto Alegre, 91350-200, Brazil

Location

Cepho - Centro de Estudos E Pesquisas de Hematologia E Oncologia

Santo André, 09060-870, Brazil

Location

A. C. Camargo Cancer Center

São Paulo, 01509-900, Brazil

Location

The People'S Hospital of Guangxi Zhuang Autonomous Region

Nanning, 530021, China

Location

High Technology Hospital Medcenter

Batumi, 06004, Georgia

Location

Jsc Evex Hospitals

Kutaisi, 04600, Georgia

Location

Caucasus Medical Centre Llc

Tbilisi, 00000, Georgia

Location

Archangel St. Michael Multi Profile Clinical Hospital

Tbilisi, 00102, Georgia

Location

Israel-Georgian Medical Research Clinic Helsicore

Tbilisi, 00112, Georgia

Location

Todua Clinic, Llc

Tbilisi, 00112, Georgia

Location

New Hospitals

Tbilisi, 00114, Georgia

Location

Tim-Tbilisi Institute of Medicine Ltd

Tbilisi, 00141, Georgia

Location

Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic, Llc

Tbilisi, 00144, Georgia

Location

Institute of Clinical Oncology Ltd

Tbilisi, 00159, Georgia

Location

Cancer Research Center Ltd

Tbilisi, 00177, Georgia

Location

Medulla Chemotherapy and Immunotherapy Clinic

Tbilisi, 00186, Georgia

Location

251 Air Force General Hospital

Athens, 115 25, Greece

Location

University Hospital of West Attica - Attikon

Athens, 12462, Greece

Location

Euromedica General Clinic of Thessaloniki

Thessaloniki, 54645, Greece

Location

Semmelweis Egyetem

Budapest, 01083, Hungary

Location

Orszagos Onkologiai Intezet

Budapest, 01122, Hungary

Location

Dunedin Hospital

Dunedin, 09016, New Zealand

Location

Rotorua Hospital

Rotorua, 03010, New Zealand

Location

Centrul Medical Medicover Victoria

Bucharest, 10626, Romania

Location

Institutul Clinic Fundeni Clinica

Bucharest, 22328, Romania

Location

Institutul Oncologic Prof. Dr. Ion Chiricuta Cluj-Napoca

Cluj-Napoca, 400015, Romania

Location

Spitalul Clinic Militar de Urgenta Dr. Constantin Papilian Cluj-Napoca

Cluj-Napoca, 400132, Romania

Location

Medisprof

Cluj-Napoca, 400641, Romania

Location

Centrul de Oncologie Sf. Nectarie Craiova

Craiova, 200347, Romania

Location

Sc Radiotherapy Center Cluj Srl

Floreşti, 407280, Romania

Location

Institutul Regional de Oncologie Iasi

Iași, 700483, Romania

Location

S.C. Medical Center Gral Srl

Ploieşti, 100337, Romania

Location

S C Oncocenter Oncologie Medicala S R L

Timișoara, 300166, Romania

Location

Oncomed Srl

Timișoara, 300239, Romania

Location

Cape Town Oncology Trials (Pty) Ltd

Cape Town, 07570, South Africa

Location

Johese Clinical Research: Midstream

Centurion, 01692, South Africa

Location

Wits Clinical Research

Johannesburg, 02193, South Africa

Location

The Medical Oncology Centre of Rosebank

Johannesburg, 02196, South Africa

Location

Phoenix Pharma (Pty) Ltd

Port Elizabeth, 06001, South Africa

Location

Medical Park Seyhan Hospital

Adana, 01140, Turkey (Türkiye)

Location

Hacettepe University Medical Faculty

Ankara, 06100, Turkey (Türkiye)

Location

Trakya University Medical Faculty

Edirne, 22030, Turkey (Türkiye)

Location

Goztepe Prof. Dr. Suleyman Yalcin City Hospital

Istanbul, 34093, Turkey (Türkiye)

Location

Kocaeli Universitesi Tip Fakultesi

Kocaeli, 41380, Turkey (Türkiye)

Location

Related Links

• A Study to Evaluate INCB099280 in Participants With Select Solid Tumors Who Are Immune Checkpoint Inhibitor Naive

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Melanoma; Carcinoma, Non-Small-Cell Lung; Carcinoma, Renal Cell

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract 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

Study Officials

• Incyte Medical Monitor

  Incyte Corporation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The study consists of 2 parts. In Part 1, participants with 6 different tumor types will be randomized 1:1:1 to INCB099280 Dose 1, INCB099280 Dose 2, or INCB099280 Dose 3 twice daily (BID). At the end of Part 1, an integrated analysis will be performed to select a dose. Once a dose is selected, Part 2 will proceed to complete enrollment for each of the 6 disease-specific cohorts at the selected dose.

Study Record Dates

• First Submitted: May 19, 2023
• First Posted: May 30, 2023
• Study Start: October 30, 2023
• Primary Completion (Estimated): July 22, 2026
• Study Completion (Estimated): July 22, 2026
• Last Updated: December 17, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
• Access Criteria: Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.

Locations

BR (13); ZA (5); TU (5); CN (1); GR (3); RO (11); NZ (2); GE (12); HU (2)