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A Phase 1/2 Study of INCB001158 in Combination With Chemotherapy in Subjects With Solid Tumors | Clinical Trials | Clareo Health

COMPLETEDPHASE1/PHASE2

A Phase 1/2 Study of INCB001158 in Combination With Chemotherapy in Subjects With Solid Tumors

A Phase 1/2 Study to Evaluate the Safety, Tolerability, and Efficacy of INCB001158 in Combination With Chemotherapy, in Subjects With Advanced or Metastatic Solid Tumors

NCT03314935•Incyte Corporation

View on ClinicalTrials.gov

Summary

The purpose of this open-label nonrandomized Phase 1/2 study is to evaluate INCB001158 in combination with chemotherapy in participants with advanced/metastatic solid tumors.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Histologically or cytologically confirmed diagnosis of selected advanced or metastatic solid tumors.
•Presence of measurable disease per RECIST v1.1.
•Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
•Baseline archival tumor specimen available or willingness to undergo a pretreatment tumor biopsy to obtain the specimen.
•Resolution of treatment-related toxicities.
•Adequate hepatic, renal, cardiac, and hematologic function.
•Additional cohort-specific criteria may apply.

Exclusion Criteria

•Subjects who participated in any other study in which receipt of an investigational study drug or device occurred within 28 days or 5 half-lives (whichever is longer) prior to first dose.
•Has received a prior monoclonal antibody within 4 weeks or 5 half-lives (whichever is shorter) before administration of study drug.
•Has had prior chemotherapy or targeted small molecule therapy within 2 weeks before administration of study treatment.
•Has received prior approved radiotherapy within 14 days of study therapy.
•Has had known additional malignancy that is progressing or requires active treatment, or history of other malignancy within 2 years of study entry.
•Has an active autoimmune disease that has required systemic treatment in past 2 years.
•Has an active infection requiring systemic therapy.
•Has known active CNS metastases and/or carcinomatous meningitis.
•Women who are pregnant or breastfeeding.

Locations (10)

University of Alabama

Birmingham, Alabama, United States

USA Mitchell Cancer Center

Mobile, Alabama, United States

UC Davis - Comprehensive Cancer Centre

Sacramento, California, United States

Northwest Georgia Oncology Centers

Marietta, Georgia, United States

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States

START San Antonio

San Antonio, Texas, United States

Grand Hopital de Charleroi - Department of Medical Oncology

Brussels, Belgium

Institut Jules Bordet - Clinical Trials Conduct Unit

Brussels, Belgium

UCL Cancer Institute

London, United Kingdom

The Christie NHS Foundation Trust

Manchester, United Kingdom

Key Dates

Start Date

November 21, 2017

Primary Completion Date

November 28, 2022

Completion Date

November 28, 2022

Last Updated

August 12, 2025

Enrollment

149

ACTUAL participants

Conditions

Biliary Tract Cancer (BTC)Colorectal Cancer (CRC)Endometrial CancerGastroesophageal Cancer (GC)Ovarian CancerSolid Tumors

Interventions

INCB001158

DRUG

Oxaliplatin

DRUG

Leucovorin

DRUG

5-Fluorouracil

DRUG

Gemcitabine

DRUG

Cisplatin

DRUG

Paclitaxel

DRUG

Study of Dato-DXd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)

NCT05489211

Endometrial CancerGastric Cancer+5 more

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RECRUITINGPHASE1/PHASE2

A Study of ART0380 for the Treatment of Advanced or Metastatic Solid Tumors

NCT04657068

Advanced CancerMetastatic Cancer+7 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 12, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

A Phase 1/2 Study of INCB001158 in Combination With Chemotherapy in Subjects With Solid Tumors

Inclusion Criteria

Exclusion Criteria

Study of Dato-DXd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)

A Study of ART0380 for the Treatment of Advanced or Metastatic Solid Tumors

A Study With NKT5097 for Adults With Advanced/Metastatic Solid Tumors

The Evaluation of PC14586 in Patients With Advanced Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)

STC-15 as a Part of Combination Therapy With Toripalimab in Selected Advanced Cancers

Study of TJ033721 (Givastomig) in Subjects With Advanced or Metastatic Solid Tumors