Clinical trial · Interventional
A Phase 1/2 Study of INCB001158 in Combination With Chemotherapy in Subjects With Solid Tumors
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
NCT03314935CI-TRIAL-00093486completedPhase 1 / Phase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Biliary Tract Cancer (BTC) | Malignant Biliary Tract Neoplasm | ALIAS | 0.85 |
| Colorectal Cancer (CRC) | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Endometrial Cancer | Malignant Endometrial Neoplasm | CURATED_BROADER | 0.80 |
| Gastroesophageal Cancer (GC) | — | UNRESOLVED | — |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5-Fluorouracil | Drug | Fluorouracil | ALIAS |
| Cisplatin | Drug | Cisplatin | ALIAS |
| Gemcitabine | Drug | Gemcitabine | ALIAS |
| INCB001158 | Drug | — | UNRESOLVED |
| Leucovorin | Drug | Leucovorin | ALIAS |
| Oxaliplatin | Drug | Oxaliplatin | ALIAS |
| Paclitaxel | Drug | Paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Treatment Group A
- description
- INCB001158 + FOLFOX
- interventionNames
- Drug: INCB001158
- Drug: Oxaliplatin
- Drug: Leucovorin
- Drug: 5-Fluorouracil
- type
- EXPERIMENTAL
- label
- Treatment Group B
- description
- INCB001158 + gemcitabine/cisplatin
- interventionNames
- Drug: INCB001158
- Drug: Gemcitabine
- Drug: Cisplatin
- type
- EXPERIMENTAL
- label
- Treatment Group C
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDAden D, Sureka N, Zaheer S, Chaurasia JK, Zaheer S. Metabolic Reprogramming in Cancer: Implications for Immunosuppressive Microenvironment. Immunology. 2025 Jan;174(1):30-72. doi: 10.1111/imm.13871. Epub 2024 Oct 27. PMID 39462179