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
2 other identifiers
interventional
149
3 countries
10
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Nov 2017
Longer than P75 for phase_1
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 16, 2017
CompletedFirst Posted
Study publicly available on registry
October 19, 2017
CompletedStudy Start
First participant enrolled
November 21, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 28, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
November 28, 2022
CompletedResults Posted
Study results publicly available
December 7, 2023
CompletedAugust 12, 2025
August 1, 2025
5 years
October 16, 2017
October 10, 2023
August 8, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Phases 1 and 2: Number of Participants With Any Treatment-emergent Adverse Event (TEAE)
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, that occurred after a participant provided informed consent. Abnormal laboratory values or test results occurring after informed consent constituted AEs only if they induced clinical signs or symptoms, were considered clinically meaningful, required therapy (e.g., hematologic abnormality that required transfusion), or required changes in the study drug(s). A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug.
up to 1385 days
Phase 1: Number of Participants With Any Dose-limiting Toxicity (DLT)
A DLT was defined as the occurrence of any protocol-defined toxicity occurring up to and including Day 28, except those with a clear alternative explanation (e.g., disease progression) or transient (≤72 hours) abnormal laboratory values without associated clinically significant signs or symptoms based on investigator determination. All DLTs were assessed by the investigator using Common Terminology Criteria for Adverse Events (CTCAE) v4.03 criteria.
up to Day 28
Recommended Phase 2 Dose (RP2D) of INCB001158 When Given in Combination With Each Chemotherapy Regimen
The RP2D of the combination of INCB001158 and chemotherapy in 21-day (for gemcitabine/cisplatin) or 28-day (for mFOLFOX6 or paclitaxel) treatment cycles in participants with advanced or metastatic solid tumors was determined. After the dose escalation was completed, the INCB001158 dose level that was pharmacologically active and tolerable in combination with each chemotherapy regimen (i.e., maximum tolerated dose or lower) was determined to be the RP2D. The RP2D was then further assessed in tumor expansion cohorts in Phase 2.
up to Day 580
Phase 2: Objective Response Rate (ORR)
ORR was defined as the percentage of participants with a best overall response of complete response (CR) or partial response (PR), as determined by investigator assessment of radiographic disease as per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (v1.1). CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 millimeters (mm). PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. Analysis was conducted by cohort (tumor type) in Phase 2 because different tumor types could have different response criteria or different background response rates.
up to 1385 days
Secondary Outcomes (9)
Phase 1: ORR
up to 580 days
Phases 1 and 2: Duration of Response
up to 368 days
Phases 1 and 2: Disease Control Rate
up to 1385 days
Phases 1 and 2: Progression-free Survival
up to 1385 days
Cmin of INCB001158 in Participants Treated With INCB001158 in Combination With Chemotherapy on Cycle 2 Day 1 Following Repeated Dose Administration
Day 1 of Cycle 2: predose; 0.5, 1, 2, 4, 6, and 8-10 hours post-dose for extensive sample collection. Day 1 of Cycle 2: predose; 1 and 4 hours post-dose for sparse sample collection
- +4 more secondary outcomes
Study Arms (3)
Treatment Group A
EXPERIMENTALINCB001158 + FOLFOX
Treatment Group B
EXPERIMENTALINCB001158 + gemcitabine/cisplatin
Treatment Group C
EXPERIMENTALINCB001158 + paclitaxel
Interventions
Phase 1: INCB001158 administered orally twice daily at the protocol-defined dose. Phase 2: INCB001158 administered orally twice daily at the recommended dose from Phase 1.
Oxaliplatin administered intravenously at the protocol-defined dose and schedule.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
University of Alabama
Birmingham, Alabama, 35294-3300, United States
USA Mitchell Cancer Center
Mobile, Alabama, 36604, United States
UC Davis - Comprehensive Cancer Centre
Sacramento, California, 95817, United States
Northwest Georgia Oncology Centers
Marietta, Georgia, 30060, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
START San Antonio
San Antonio, Texas, 78229, United States
Grand Hopital de Charleroi - Department of Medical Oncology
Brussels, 6000, Belgium
Institut Jules Bordet - Clinical Trials Conduct Unit
Brussels, B-1000, Belgium
UCL Cancer Institute
London, WC1E 6BT, United Kingdom
The Christie NHS Foundation Trust
Manchester, M20 4BX, United Kingdom
Related Publications (1)
Aden D, Sureka N, Zaheer S, Chaurasia JK, Zaheer S. Metabolic Reprogramming in Cancer: Implications for Immunosuppressive Microenvironment. Immunology. 2025 Jan;174(1):30-72. doi: 10.1111/imm.13871. Epub 2024 Oct 27.
PMID: 39462179DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Incyte Corporation
Study Officials
- STUDY DIRECTOR
Lance Leopold, MD
Incyte Corporation
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 16, 2017
First Posted
October 19, 2017
Study Start
November 21, 2017
Primary Completion
November 28, 2022
Study Completion
November 28, 2022
Last Updated
August 12, 2025
Results First Posted
December 7, 2023
Record last verified: 2025-08
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.
Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency