Clinical Trials /

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

NCT03314935

Description:

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.

Related Conditions:
  • Malignant Solid Tumor
Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: 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

Clinical Trial IDs

  • ORG STUDY ID: INCB 01158-203
  • NCT ID: NCT03314935

Conditions

  • Biliary Tract Cancer (BTC)
  • Colorectal Cancer (CRC)
  • Endometrial Cancer
  • Gastroesophageal Cancer (GC)
  • Ovarian Cancer
  • Solid Tumors

Interventions

DrugSynonymsArms
INCB001158Arginase inhibitorTreatment Group A
OxaliplatinTreatment Group A
LeucovorinTreatment Group A
5-FluorouracilTreatment Group A
GemcitabineTreatment Group B
CisplatinTreatment Group B
PaclitaxelTreatment Group C

Purpose

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 Arms

NameTypeDescriptionInterventions
Treatment Group AExperimentalINCB001158 + FOLFOX
  • INCB001158
  • Oxaliplatin
  • Leucovorin
  • 5-Fluorouracil
Treatment Group BExperimentalINCB001158 + gemcitabine/cisplatin
  • INCB001158
  • Gemcitabine
  • Cisplatin
Treatment Group CExperimentalINCB001158 + paclitaxel
  • INCB001158
  • Paclitaxel

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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Phase 1: Participants with treatment-emergent adverse events (TEAE)
Time Frame:28 days
Safety Issue:
Description:TEAE is defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug.

Secondary Outcome Measures

Measure:Phase 2: Participants with TEAEs
Time Frame:Screening through 90 days after end of treatment, up to 21 months.
Safety Issue:
Description:TEAE is defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug.
Measure:Phase 1: Objective response rate
Time Frame:Every 8 weeks for duration of study participation, up to 18 months.
Safety Issue:
Description:Defined as the percentage of subjects having a CR or PR per RECIST v1.1.
Measure:Duration of response
Time Frame:Every 8 weeks for duration of study participation, up to 18 months.
Safety Issue:
Description:Defined as the time from earliest date of CR or PR (per RECIST v1.1) until the earliest date of disease progression or death due to any cause, if occurring sooner than disease progression.
Measure:Disease control rate
Time Frame:Every 8 weeks for duration of study participation, up to 18 months.
Safety Issue:
Description:Defined as the percentage of subjects having CR, PR, or stable disease for at least 8 weeks (per RECIST v1.1).
Measure:Progression-free survival
Time Frame:Every 8 weeks for duration of study participation, up to 18 months
Safety Issue:
Description:Defined as the time from date of first dose of study drug until the earliest date of disease progression (per RECIST v1.1) or death due to any cause, if occurring sooner than progression.

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Incyte Corporation

Trial Keywords

  • INCB001158
  • arginase inhibitor
  • oxaliplatin
  • leucovorin
  • 5 fluorouracil
  • gemcitabine
  • cisplatin
  • paclitaxel
  • solid tumors
  • colorectal cancer
  • biliary tract cancer
  • gastroesophageal cancer
  • endometrial cancer
  • ovarian cancer

Last Updated

May 28, 2019