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

Incyte

Status and phase: Completed; Phase 2; Phase 1

Conditions: Endometrial Cancer; Colorectal Cancer (CRC); Gastroesophageal Cancer (GC); Biliary Tract Cancer (BTC); Solid Tumors; Ovarian Cancer

Treatments: Drug: Leucovorin; Drug: Paclitaxel; Drug: Cisplatin; Drug: 5-Fluorouracil; Drug: INCB001158; Drug: Oxaliplatin; Drug: Gemcitabine

Study type: Interventional

Funder types: Industry

Identifiers

NCT03314935

2017-002904-29 (EudraCT Number)

INCB 01158-203

Details and patient eligibility

About

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.

Enrollment: 149 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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149 participants in 3 patient groups

Treatment Group A

Experimental group

Description:

INCB001158 + FOLFOX

Treatment:

Drug: Oxaliplatin

Drug: INCB001158

Drug: 5-Fluorouracil

Drug: Leucovorin

Treatment Group B

Experimental group

Description:

INCB001158 + gemcitabine/cisplatin

Treatment:

Drug: Gemcitabine

Drug: INCB001158

Drug: Cisplatin

Treatment Group C

Experimental group

Description:

INCB001158 + paclitaxel

Treatment:

Drug: INCB001158

Drug: Paclitaxel