Clinical trial NCT03314935: A Phase 1/2 Study of INCB001158 in Combination With Chemotherapy in Subjects With Solid Tumors
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
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
solid tumors
colorectal cancer
biliary tract cancer
gastroesophageal cancer
endometrial cancer
ovarian cancer
Lead sponsor: Incyte Corporation
Sponsor class: INDUSTRY
First posted: 2017-10-19
Enrollment: 149
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Phases 1 and 2: Number of Participants With Any Treatment-emergent Adverse Event (TEAE)
timeFrame: up to 1385 days
measure: Phase 1: Number of Participants With Any Dose-limiting Toxicity (DLT)
timeFrame: up to Day 28
measure: Recommended Phase 2 Dose (RP2D) of INCB001158 When Given in Combination With Each Chemotherapy Regimen
timeFrame: up to Day 580
measure: Phase 2: Objective Response Rate (ORR)
timeFrame: up to 1385 days
Secondary outcomes:
measure: Phase 1: ORR
timeFrame: up to 580 days
measure: Phases 1 and 2: Duration of Response
timeFrame: up to 368 days
measure: Phases 1 and 2: Disease Control Rate
timeFrame: up to 1385 days
measure: Phases 1 and 2: Progression-free Survival
timeFrame: up to 1385 days
measure: Cmin of INCB001158 in Participants Treated With INCB001158 in Combination With Chemotherapy on Cycle 2 Day 1 Following Repeated Dose Administration
timeFrame: 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
measure: 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
timeFrame: 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
measure: 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
timeFrame: 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
measure: 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
timeFrame: 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
measure: 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
timeFrame: 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
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama
state: Alabama
city: Mobile
country: United States
facility: USA Mitchell Cancer Center
state: Alabama
city: Sacramento
country: United States
facility: UC Davis - Comprehensive Cancer Centre
state: California
city: Marietta
country: United States
facility: Northwest Georgia Oncology Centers
state: Georgia
city: Houston
country: United States
facility: The University of Texas MD Anderson Cancer Center
state: Texas
city: San Antonio
country: United States
facility: START San Antonio
state: Texas
city: Brussels
country: Belgium
facility: Grand Hopital de Charleroi - Department of Medical Oncology
city: Brussels
country: Belgium
facility: Institut Jules Bordet - Clinical Trials Conduct Unit
city: London
country: United Kingdom
facility: UCL Cancer Institute
city: Manchester
country: United Kingdom
facility: The Christie NHS Foundation Trust
Study officials:
affiliation: Incyte Corporation
name: Lance Leopold, MD
role: STUDY_DIRECTOR
References: