Summary

for people ages 18 years and up (full criteria)
at Sacramento, California and other locations
study started
estimated completion

Description

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.

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

Keywords

Biliary Tract Cancer (BTC) Colorectal Cancer (CRC) Endometrial Cancer Gastroesophageal Cancer (GC) Ovarian Cancer Solid Tumors INCB001158 arginase inhibitor oxaliplatin leucovorin 5 fluorouracil gemcitabine cisplatin paclitaxel colorectal cancer biliary tract cancer gastroesophageal cancer Colorectal Neoplasms Ovarian Neoplasms Endometrial Neoplasms Biliary Tract Neoplasms Albumin-Bound Paclitaxel Fluorouracil CB-1158 5-Fluorouracil

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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 CAN'T join 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.

Locations

  • UC Davis - Comprehensive Cancer Centre accepting new patients
    Sacramento California 95817 United States
  • START San Antonio accepting new patients
    San Antonio Texas 78229 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Incyte Corporation
Links
Sign up for this study
ID
NCT03314935
Phase
Phase 1/2
Study Type
Interventional
Last Updated