Open-Label Safety and Tolerability Study of INCB057643 in Subjects With Advanced Malignancies
The purpose of the Study is to select a dose and assess the safety and tolerability of INCB057643 as a monotherapy (Part 1 and Part 2) and in combination with standard-of-care (SOC) agents (Part 3 and Part 4) for subjects with advanced malignancies. Part 1 will determine the maximum tolerated dose of INCB057643 and/or a tolerated dose that demonstrates sufficient pharmacologic activity. Part 2 will further evaluate the safety, preliminary efficacy, PK, and PD of the dose(s) selected in Part 1 in select tumor types including solid tumors, lymphomas and other hematologic malignancies. Part 3 will determine the tolerated dose of INCB057643 in combination with select SOC agents; and assess the safety and tolerability of the combination therapy in select advanced solid tumors and hematologic malignancies. Part 4 will further evaluate the safety, preliminary efficacy, PK, and PD of the selected dose combination from Part 3 in 4 specific advanced solid tumor and hematologic malignancies.
Checked against the public recordLast updated Oct 21, 2025 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1 / Phase 2
- Sponsor
- Incyte Corporation
- Interventions being studied
- Drug: INCB057643; Drug: Gemcitabine; Drug: Paclitaxel; Drug: Rucaparib; Drug: Abiraterone; Drug: Ruxolitinib; Drug: Azacitidine
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
Inclusion Criteria: * Histologically or cytologically confirmed diagnosis of relapsed or refractory advanced or metastatic malignancies: * Part 1: solid tumors or lymphomas, or hematologic malignancies * Part 2: histologically confirmed disease in specific tumor types * Part 3: advanced solid tumor or hematologic malignancy * Part 4: select advanced solid tumor or hematologic malignancy * For Part 1 and 2, subjects must have progressed following at least 1 line of prior therapy and there is no further established therapy that is known to provide clinical benefit (including subjects who are intolerant to the established therapy) * For Parts 3 and 4, subjects must have progressed following at least 1 line of prior therapy, and the treatment with the select SOC agent is relevant for the specific disease cohort. * Life expectancy \> 12 weeks, for MF subjects in Parts 3 and 4, life expectancy \> 24 weeks * Eastern Cooperative Oncology Group (ECOG) performance status * Parts 1 and 3: 0 or 1 * Parts 2 and 4: 0, 1, or 2 * Willingness to avoid pregnancy or fathering children Exclusion Criteria: * Inadequate bone marrow function per protocol-specified hemoglobin, platelet count, and absolute neutrophil count * Inadequate organ function per protocol-specified total bilirubin, AST and ALT, creatinine clearance and alkaline phosphatase. * Receipt of anticancer medications or investigational drugs within protocol-specified intervals * Unless approved by the medical monitor, may not have received an allogeneic hematopoietic stem cell transplant within 6 months before treatment, or have active graft-versus-host-disease following allogeneic transplant * Unless approved by the medical monitor, may not have received autologous hematopoietic stem cell transplant within 3 months before treatment * Any unresolved toxicity ≥ Grade 2 (except stable Grade 2 peripheral neuropathy or alopecia) from previous anticancer therapy * Radiotherapy within the 2 weeks before initiation of treatment. Palliative radiation treatment to nonindex or bone lesions performed less than 2 weeks before treatment initiation may be considered with medical monitor approval * Currently active and uncontrolled infectious disease requiring systemic antibiotic, antifungal, or antiviral treatment * Untreated brain or central nervous system (CNS) metastases or brain/CNS metastases that have progressed * History or presence of abnormal electrocardiogram (ECG) that, in the investigator's opinion, is clinically meaningful * Type 1 diabetes or uncontrolled Type 2 diabetes * HbA1c of ≥ 8% (all subjects will have HbA1c test at screening) * Any sign of clinically significant bleeding * Coagulation panel within protocol-specified parameters
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- University of AlabamaBirmingham, Alabama
- University of CaliforniaLa Jolla, California
- Sarah Cannon Research Institute at Health OneDenver, Colorado
- Yale UniversityNew Haven, Connecticut
- Sylvester Comprehensive Cancer CenterMiami, Florida
- Hematology - Oncology Associates of Treasure CoastPort Saint Lucie, Florida
- University of MichiganAnn Arbor, Michigan
- University of MinnesotaMinneapolis, Minnesota
- Washington UniversitySt Louis, Missouri
- University of Rochester, Wilmot Cancer CenterRochester, New York
- University of North Carolina at Chapel HillChapel Hill, North Carolina
- Wake Forest Baptist HealthWinston-Salem, North Carolina
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Oct 21, 2025. Always confirm current availability with the study team.