Biliary Tract Cancer (BTC)Phase 1/2NCT03314935

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

A Phase 1/2 study testing INCB001158, Oxaliplatin and Leucovorin in people with Biliary Tract Cancer (BTC) and Colorectal Cancer (CRC), run by Incyte Corporation at 10 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Biliary Tract Cancer (BTC), Colorectal Cancer (CRC), Endometrial Cancer
What is being tested?: INCB001158, Oxaliplatin and Leucovorin
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 149 participants
Where: 10 sitesin 3 countries
Study dates: 21 Nov 2017to 28 Nov 2022
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Show all 9Show fewer

Has an active infection requiring systemic therapy.
Has known active CNS metastases and/or carcinomatous meningitis.
Women who are pregnant or breastfeeding.

Trial locations and contacts

10 sites in 3 countries.

Country

City, postcode or hospital

10 sites in 3 countries

United States6 sites

University of Alabama
Birmingham, Alabama, 35294-3300
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Northwest Georgia Oncology Centers
Marietta, Georgia, 30060
USA Mitchell Cancer Center
Mobile, Alabama, 36604
UC Davis - Comprehensive Cancer Centre
Sacramento, California, 95817
START San Antonio
San Antonio, Texas, 78229

Other trials in United States

Belgium2 sites

Grand Hopital de Charleroi - Department of Medical Oncology
Brussels, 6000
Institut Jules Bordet - Clinical Trials Conduct Unit
Brussels, B-1000

Other trials in Belgium

United Kingdom2 sites

UCL Cancer Institute
London, WC1E 6BT
The Christie NHS Foundation Trust
Manchester, M20 4BX

Other trials in United Kingdom

About this study

Official title: 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

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.

Conditions: Biliary Tract Cancer (BTC), Colorectal Cancer (CRC), Endometrial Cancer, Gastroesophageal Cancer (GC), Ovarian Cancer, Solid Tumors
Being tested: INCB001158, Oxaliplatin, Leucovorin, 5-Fluorouracil, Gemcitabine
Keywords: INCB001158, arginase inhibitor, oxaliplatin, leucovorin, 5 fluorouracil, gemcitabine, cisplatin, paclitaxel, solid tumors, colorectal cancer, biliary tract cancer, gastroesophageal cancer, endometrial cancer, ovarian cancer
Medical subject headings: Biliary Tract Neoplasms, Colorectal Neoplasms, Endometrial Neoplasms, Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

INCB001158Drug
Also called Arginase inhibitor
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.
OxaliplatinDrug
Oxaliplatin administered intravenously at the protocol-defined dose and schedule.
LeucovorinDrug
Leucovorin at the protocol-defined dose and regimen.
5-FluorouracilDrug
5-Fluorouracil at the protocol-defined dose and regimen.
GemcitabineDrug
Gemcitabine at the protocol-defined dose and regimen.
CisplatinDrug
Cisplatin at the protocol-defined dose and regimen.
PaclitaxelDrug
Paclitaxel at the protocol-defined dose and regimen.

Study groups in NCT03314935
Study group	Role	What they receive
Treatment Group A	Experimental	INCB001158 + FOLFOX Receives: Drug: INCB001158; Drug: Oxaliplatin; Drug: Leucovorin; Drug: 5-Fluorouracil
Treatment Group B	Experimental	INCB001158 + gemcitabine/cisplatin Receives: Drug: INCB001158; Drug: Gemcitabine; Drug: Cisplatin
Treatment Group C	Experimental	INCB001158 + paclitaxel Receives: Drug: INCB001158; Drug: Paclitaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: up to 1385 days

Secondary outcomes (9)

Phase 1: ORR
ORR was defined as the percentage of participants with a confirmed best overall response of CR or PR, as determined by investigator assessment of radiographic disease as per RECIST 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 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.
Measured: up to 580 days
Phases 1 and 2: Duration of Response
DOR was defined as the time from initial objective response (CR or PR) (as determined by investigator assessment of radiographic disease assessment per RECIST v1.1) until the earliest date of disease progression or death due to any cause, if it occurred sooner than disease progression. 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 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. PD: progression of a target or non-target lesion or presence of a new lesion.
Measured: up to 368 days
Phases 1 and 2: Disease Control Rate
DCR was defined as the percentage of participants with an overall response of CR, PR, or stable disease (SD), as determined by investigator assessment of radiographic disease as per RECIST v1.1, for at least 8 weeks. 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 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. PD: progression of a target or non-target lesion or presence of a new lesion. SD: no change in target lesions to qualify for CR, PR, or PD.
Measured: up to 1385 days
Phases 1 and 2: Progression-free Survival
According to RECIST 1.1, PFS was defined as the length of time from the date of the first dose study of drug until the earliest date of disease progression, as determined by investigator assessment of radiographic disease per RECIST v1.1, or death due to any cause, if it occurred sooner than progression.
Measured: 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
Cmin was defined as the minimum observed plasma concentration over the dose interval. Extensive sample collection was used for the first 12 participants enrolled in each chemotherapy regimen. Sparse sample collection was used for the 13th participant enrolled and onward.
Measured: 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
Cmax of INCB001158 in Participants Treated With INCB001158 in Combination With Chemotherapy Following the First Dose on Cycle 1 Day 1 and on Cycle 2 Day 1 Following Repeated Dose Administration
Cmax was defined as the maximum observed plasma concentration over the dose interval. Extensive sample collection was used for the first 12 participants enrolled in each chemotherapy regimen. Sparse sample collection was used for the 13th participant enrolled and onward.
Measured: Day 1 of Cycles 1 and 2: predose; 0.5, 1, 2, 4, 6, and 8-10 hours post-dose for extensive sample collection. Day 1 of Cycles 1 and 2: predose; 1 and 4 hours post-dose for sparse sample collection
Tmax of INCB001158 in Participants Treated With INCB001158 in Combination With Chemotherapy Following the First Dose on Cycle 1 Day 1 and on Cycle 2 Day 1 Following Repeated Dose Administration
tmax was defined as the time to the maximum concentration. Extensive sample collection was used for the first 12 participants enrolled in each chemotherapy regimen. Sparse sample collection was used for the 13th participant enrolled and onward.
Measured: Day 1 of Cycles 1 and 2: predose; 0.5, 1, 2, 4, 6, and 8-10 hours post-dose for extensive sample collection. Day 1 of Cycles 1 and 2: predose; 1 and 4 hours post-dose for sparse sample collection
AUC0-t of INCB001158 in Participants Treated With INCB001158 in Combination With Chemotherapy Following the First Dose on Cycle 1 Day 1 and on Cycle 2 Day 1 Following Repeated Dose Administration
AUC0-t was defined as the area under the plasma concentration-time curve from time = 0 to the last measurable concentration at time = t. Extensive sample collection was used for the first 12 participants enrolled in each chemotherapy regimen. Sparse sample collection was used for the 13th participant enrolled and onward.
Measured: Day 1 of Cycles 1 and 2: predose; 0.5, 1, 2, 4, 6, and 8-10 hours post-dose for extensive sample collection. Day 1 of Cycles 1 and 2: predose; 1 and 4 hours post-dose for sparse sample collection
Tlast of INCB001158 in Participants Treated With INCB001158 in Combination With Chemotherapy Following the First Dose on Cycle 1 Day 1 and on Cycle 2 Day 1 Following Repeated Dose Administration
tlast was defined as the time of the last sample collected from which a concentration was measured. Extensive sample collection was used for the first 12 participants enrolled in each chemotherapy regimen. Sparse sample collection was used for the 13th participant enrolled and onward.
Measured: Day 1 of Cycles 1 and 2: predose; 0.5, 1, 2, 4, 6, and 8-10 hours post-dose for extensive sample collection. Day 1 of Cycles 1 and 2: predose; 1 and 4 hours post-dose for sparse sample collection

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Nov 201728 Nov 2022

First posted19 Oct 2017
Study start21 Nov 2017
Primary completion28 Nov 2022
Study completion28 Nov 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Biliary Tract Cancer (BTC)Studies of the same condition, open and under way.
More trials run by Incyte CorporationThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 149 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03314935
Sponsor's protocol ID: INCB 01158-203
Other IDs: 2017-002904-29, 2017
Status last verified: Aug 2025
First submitted: 16 Oct 2017
Last updated: 12 Aug 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: 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

Publications

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.
PubMed 39462179

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Advanced Solid Tumors, HER2 Mutation
RecruitingPhase 3
D07001 Softgel-Capsules and Capecitabine Combination Therapy in Patients With Advanced Biliary Tract Cancer
Biliary Tract Cancer (BTC)
Not yet recruitingPhase 2
Daraxonrasib in Asian RAS-mutant Biliary Tract Cancer
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All Biliary Tract Cancer (BTC) trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT03314935
Acronym / sponsor ID: INCB 01158-203
Conditions: Biliary Tract Cancer (BTC), Colorectal Cancer (CRC), Endometrial Cancer, Gastroesophageal Cancer (GC), Ovarian Cancer, Solid Tumors
Keywords: INCB001158, arginase inhibitor, oxaliplatin, leucovorin, 5 fluorouracil, gemcitabine, cisplatin, paclitaxel
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 149 participants (actual)
Lead sponsor: Incyte CorporationIndustry (pharma, biotech, devices)
Study start: 21 Nov 2017 (actual)
Primary completion: 28 Nov 2022 (actual)
Study completion: 28 Nov 2022 (actual)
First posted: 19 Oct 2017 (actual)
Results: Posted 7 Dec 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Treatment Group A	Experimental	Drug: INCB001158, Drug: Oxaliplatin, Drug: Leucovorin, Drug: 5-FluorouracilINCB001158 + FOLFOX
Treatment Group B	Experimental	Drug: INCB001158, Drug: Gemcitabine, Drug: CisplatinINCB001158 + gemcitabine/cisplatin
Treatment Group C	Experimental	Drug: INCB001158, Drug: PaclitaxelINCB001158 + paclitaxel

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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.

Key exclusion criteria (9 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
INCB001158Also: Arginase inhibitorPhase 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.	Drug	Treatment Group A, Treatment Group B, Treatment Group C
OxaliplatinOxaliplatin administered intravenously at the protocol-defined dose and schedule.	Drug	Treatment Group A
LeucovorinLeucovorin at the protocol-defined dose and regimen.	Drug	Treatment Group A
5-Fluorouracil5-Fluorouracil at the protocol-defined dose and regimen.	Drug	Treatment Group A
GemcitabineGemcitabine at the protocol-defined dose and regimen.	Drug	Treatment Group B
CisplatinCisplatin at the protocol-defined dose and regimen.	Drug	Treatment Group B
PaclitaxelPaclitaxel at the protocol-defined dose and regimen.	Drug	Treatment Group C

Primary outcome

Phases 1 and 2: Number of Participants With Any Treatment-emergent Adverse Event (TEAE)
Time frame: up to 1385 days
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.
Phase 1: Number of Participants With Any Dose-limiting Toxicity (DLT)
Time frame: up to Day 28
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.
Recommended Phase 2 Dose (RP2D) of INCB001158 When Given in Combination With Each Chemotherapy Regimen
Time frame: up to Day 580
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.
Phase 2: Objective Response Rate (ORR)
Time frame: up to 1385 days
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.

9 secondary outcomes

Phase 1: ORR
Time frame: up to 580 days
Phases 1 and 2: Duration of Response
Time frame: up to 368 days
Phases 1 and 2: Disease Control Rate
Time frame: up to 1385 days
Phases 1 and 2: Progression-free Survival
Time frame: 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
Time frame: 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
Cmax of INCB001158 in Participants Treated With INCB001158 in Combination With Chemotherapy Following the First Dose on Cycle 1 Day 1 and on Cycle 2 Day 1 Following Repeated Dose Administration
Time frame: Day 1 of Cycles 1 and 2: predose; 0.5, 1, 2, 4, 6, and 8-10 hours post-dose for extensive sample collection. Day 1 of Cycles 1 and 2: predose; 1 and 4 hours post-dose for sparse sample collection
Tmax of INCB001158 in Participants Treated With INCB001158 in Combination With Chemotherapy Following the First Dose on Cycle 1 Day 1 and on Cycle 2 Day 1 Following Repeated Dose Administration
Time frame: Day 1 of Cycles 1 and 2: predose; 0.5, 1, 2, 4, 6, and 8-10 hours post-dose for extensive sample collection. Day 1 of Cycles 1 and 2: predose; 1 and 4 hours post-dose for sparse sample collection
AUC0-t of INCB001158 in Participants Treated With INCB001158 in Combination With Chemotherapy Following the First Dose on Cycle 1 Day 1 and on Cycle 2 Day 1 Following Repeated Dose Administration
Time frame: Day 1 of Cycles 1 and 2: predose; 0.5, 1, 2, 4, 6, and 8-10 hours post-dose for extensive sample collection. Day 1 of Cycles 1 and 2: predose; 1 and 4 hours post-dose for sparse sample collection
Tlast of INCB001158 in Participants Treated With INCB001158 in Combination With Chemotherapy Following the First Dose on Cycle 1 Day 1 and on Cycle 2 Day 1 Following Repeated Dose Administration
Time frame: Day 1 of Cycles 1 and 2: predose; 0.5, 1, 2, 4, 6, and 8-10 hours post-dose for extensive sample collection. Day 1 of Cycles 1 and 2: predose; 1 and 4 hours post-dose for sparse sample collection

Results and safety

Results posted to the registry on 7 Dec 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Phase 1: INCB001158 50 mg + mFOLFOX6	8	0
Phase 1: INCB001158 75 mg + mFOLFOX6	6	0
Phase 1: INCB001158 100 mg + mFOLFOX6	6	0
Phase 1: INCB001158 50 mg + Gemcitabine + Cisplatin	7	0
Phase 1: INCB001158 75 mg + Gemcitabine + Cisplatin	4	0
Phase 1: INCB001158 100 mg + Gemcitabine + Cisplatin	4	0
Phase 1: INCB001158 50 mg + Paclitaxel	7	0
Phase 1: INCB001158 75 mg + Paclitaxel	5	0
Phase 1: INCB001158 100 mg + Paclitaxel	7	0
Phase 2: INCB001158 100 mg + mFOLFOX6: MSS-CRC (Cohort A1)	0	0
Phase 2: INCB001158 100 mg + Gemcitabine + Cisplatin: BTC (Cohort B1)	0	0
Phase 2: INCB001158 100 mg + Gemcitabine + Cisplatin: OC (Cohort B2)	0	0
Phase 2: INCB001158 100 mg + Paclitaxel: GC (Cohort C1)	0	0
Phase 2: INCB001158 100 mg + Paclitaxel: EC (Cohort C2)	0	0
Phase 2: INCB001158 100 mg + Paclitaxel: OC (Cohort C3)	0	0

Primary outcome: Phases 1 and 2: Number of Participants With Any Treatment-emergent Adverse Event (TEAE)

Time frame: up to 1385 days. Count of participants. Unit: Participants

Measure	Phase 1 and Phase 2: INCB001158 50 mg + mFOLFOX6 n = 8	Phase 1 and Phase 2: INCB001158 75 mg + mFOLFOX6 n = 6	Phase 1 and Phase 2: INCB001158 100 mg + mFOLFOX6 n = 14	Phase 1 and Phase 2: INCB001158 50 mg + Gemcitabine + Cisplatin n = 7	Phase 1 and Phase 2: INCB001158 75 mg + Gemcitabine + Cisplatin n = 4	Phase 1 and Phase 2: INCB001158 100 mg + Gemcitabine + Cisplatin n = 46	Phase 1 and Phase 2: INCB001158 50 mg + Paclitaxel n = 7	Phase 1 and Phase 2: INCB001158 75 mg + Paclitaxel n = 5	Phase 1 and Phase 2: INCB001158 100 mg + Paclitaxel n = 52
Value	8	6	13	7	4	46	7	5	51

Population analysed: Full Analysis Set (FAS): all participants enrolled in the study who received at least 1 dose of INCB001158, mFOLFOX6, gemcitabine/cisplatin, or paclitaxel. As pre-defined in the Statistical Analysis Plan, data analysis was conducted based on treatment group and dose level, regardless of study phase, because the safety profile was expected to be generally uniform across tumor types.

Primary outcome: Phase 1: Number of Participants With Any Dose-limiting Toxicity (DLT)

Time frame: up to Day 28. Count of participants. Unit: Participants

Measure	Phase 1: INCB001158 50 mg + mFOLFOX6 n = 8	Phase 1: INCB001158 75 mg + mFOLFOX6 n = 6	Phase 1: INCB001158 100 mg + mFOLFOX6 n = 6	Phase 1: INCB001158 50 mg + Gemcitabine + Cisplatin n = 7	Phase 1: INCB001158 75 mg + Gemcitabine + Cisplatin n = 4	Phase 1: INCB001158 100 mg + Gemcitabine + Cisplatin n = 4	Phase 1: INCB001158 50 mg + Paclitaxel n = 7	Phase 1: INCB001158 75 mg + Paclitaxel n = 5	Phase 1: INCB001158 100 mg + Paclitaxel n = 7
Value	0	0	0	1	0	0	0	0	0

Population analysed: Phase 1 DLT Evaluable Population: all participants enrolled in Phase 1 who had been treated with the assigned dose level of INCB001158 and who had received at least 32 of the 42 doses prescribed for a 21-day cycle regimen or at least 42 of the 56 doses prescribed for a 28-day cycle regimen (both representing ≥ 75% of the dose planned) or who had experienced a DLT

Primary outcome: Recommended Phase 2 Dose (RP2D) of INCB001158 When Given in Combination With Each Chemotherapy Regimen

Time frame: up to Day 580. Number. Unit: milligrams

Measure	All Phase 1 Participants n = 54
Value	100

Population analysed: DLT Evaluable Population

Primary outcome: Phase 2: Objective Response Rate (ORR)

Time frame: up to 1385 days. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Phase 2: INCB001158 100 mg + mFOLFOX6: MSS-CRC (Cohort A1) n = 8	Phase 2: INCB001158 100 mg + Gemcitabine + Cisplatin: BTC (Cohort B1) n = 33	Phase 2: INCB001158 100 mg + Gemcitabine + Cisplatin: OC (Cohort B2) n = 9	Phase 2: INCB001158 100 mg + Paclitaxel: GC (Cohort C1) n = 11	Phase 2: INCB001158 100 mg + Paclitaxel: EC (Cohort C2) n = 10	Phase 2: INCB001158 100 mg + Paclitaxel: OC (Cohort C3) n = 24
Value	0.0 (0.0 to 36.9)	24.2 (11.1 to 42.3)	22.2 (2.8 to 60.0)	9.1 (0.2 to 41.3)	30.0 (6.7 to 65.2)	16.7 (4.7 to 37.4)

Population analysed: Phase 2 Response Evaluable Population: all participants who had received ≥1 dose of study treatment (INCB001158, mFOLFOX6, gemcitabine/cisplatin, or paclitaxel), completed a Baseline scan, and met ≥1 of the following criteria: (a) had ≥1 post-Baseline scan; (b) was in the study for a minimum of 63 days (8 weeks + 1 week window) of follow-up; (c) discontinued from study treatment

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: up to 1385 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Phase 1 and Phase 2: INCB001158 50 mg + mFOLFOX6	6 of 8 (75%)	8 of 8 (100%)	4 of 8
Phase 1 and Phase 2: INCB001158 75 mg + mFOLFOX6	1 of 6 (16.7%)	6 of 6 (100%)	2 of 6
Phase 1 and Phase 2: INCB001158 100 mg + mFOLFOX6	7 of 14 (50%)	13 of 14 (92.9%)	11 of 14
Phase 1 and Phase 2: INCB001158 50 mg + Gemcitabine + Cisplatin	3 of 7 (42.9%)	7 of 7 (100%)	4 of 7
Phase 1 and Phase 2: INCB001158 75 mg + Gemcitabine + Cisplatin	1 of 4 (25%)	4 of 4 (100%)	3 of 4
Phase 1 and Phase 2: INCB001158 100 mg + Gemcitabine + Cisplatin	30 of 46 (65.2%)	45 of 46 (97.8%)	30 of 46
Phase 1 and Phase 2: INCB001158 50 mg + Paclitaxel	4 of 7 (57.1%)	7 of 7 (100%)	5 of 7
Phase 1 and Phase 2: INCB001158 75 mg + Paclitaxel	4 of 5 (80%)	5 of 5 (100%)	4 of 5
Phase 1 and Phase 2: INCB001158 100 mg + Paclitaxel	27 of 52 (51.9%)	50 of 52 (96.2%)	36 of 52
Total	83 of 149 (55.7%)	145 of 149 (97.3%)	99 of 149

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 39462179Aden 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.
Individual participant dataSharing planned: Yes. 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

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Lance Leopold, MD study director

Incyte Corporation

10 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing INCB001158, Oxaliplatin and Leucovorin in people with Biliary Tract Cancer (BTC) and Colorectal Cancer (CRC), run by Incyte Corporation at 10 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in United States, Belgium, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phases 1 and 2: Number of Participants With Any Treatment-emergent Adverse Event (TEAE) (time frame: up to 1385 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03314935, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2025; AzTrials last refreshed its copy on 6 Nov 2026.