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

• Status: Active, not recruiting
• Trial end date: 2021-10-06
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Incyte Corporation
• Treatments: Albumin-Bound Paclitaxel; Cisplatin; Fluorouracil; Gemcitabine; Leucovorin; Oxaliplatin; Paclitaxel

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.