INCB106385 Alone or in Combination With Immunotherapy in Advanced Solid Tumors
This is a multicenter, open-label, dose-escalation/dose-expansion Phase 1 clinical study to investigate the safety, tolerability, PK profile, pharmacodynamics, and preliminary clinical efficacy of INCB106385 when given as monotherapy or in combination with INCMGA00012 in participants with selected CD8 T-cell-positive advanced solid tumors including SCCHN, NSCLC, ovarian cancer, CRPC, TNBC, bladder cancer, and specified GI malignancies (defined as CRC, gastric/GEJ cancer, HCC, PDAC, or SCAC)
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
The study team can explain what participation involves.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Jul 11, 2025 · Source: ClinicalTrials.gov
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Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1
- Sponsor
- Incyte Corporation
- Interventions being studied
- Drug: INCB106385; Drug: INCMGA00012
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- Ability to comprehend and willingness to sign an ICF.
- Willing and able to conform to and comply with all Protocol requirements.
- Histologically or cytologically confirmed advanced/metastatic SCCHN, NSCLC, ovarian cancer, TNBC, CRPC, bladder cancer, and specified GI malignancies (defined as CRC, gastric/GEJ cancer, HCC, PDAC, or SCAC) that progressed after treatment with available therapies (including anti PD-(L)1 therapy (if applicable).
- Willingness to undergo pre- and on-treatment tumor biopsy.
- Have CD8 T-cell-positive tumors.
- Presence of measurable disease according to RECIST v1.1.
- ECOG performance status 0 to 1.
- Life expectancy \> 12 weeks.
- Willingness to avoid pregnancy or fathering children based.
- Acceptable laboratory parameters
- Clinically significant cardiac disease.
- Known or active CNS metastases and/or carcinomatous meningitis.
- Active or inactive autoimmune disease or syndrome that required systemic treatment in the past 2 years or receiving systemic therapy for an autoimmune or inflammatory disease..
- Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (doses \> 10 mg daily of prednisone or equivalent) or any other form of immunosuppressive therapy within 7 days before the first dose of study treatment.
- Known additional malignancy that is progressing or requires active treatment,or history of other malignancy within 2 years of the first dose of study treatment.
- Has not recovered to ≤ Grade 1 from toxic effects of prior therapy and/or complications from prior surgical intervention before starting study treatment.
- Evidence of interstitial lung disease, history of interstitial lung disease, or active, noninfectious pneumonitis.
- Immune-related toxicity during prior immune therapy for which permanent discontinuation of therapy is recommended, or any immune-related toxicity requiring intensive or prolonged immunosuppression to manage.
- Any prior chemotherapy, biological therapy, or targeted therapy to treat the participant's disease within 5 half-lives or 28 days (whichever is shorter) before the first dose of study treatment.
- Any prior radiation therapy within 28 days before the first dose of study treatment.
- Undergoing treatment with another investigational medication or having been treated with an investigational medication within 5 half-lives or 28 days (whichever is shorter) before the first dose of study treatment.
- Concomitant treatment with strong CYP3A4 inhibitors or inducers.
- Receipt of a live vaccine within 30 days of the first dose of study treatment.
- Infection requiring parenteral antibiotics, antivirals, or antifungals within 1 week of the first dose of study treatment.
- Evidence of HBV or HCV infection or risk of reactivation.
- Known history of HIV (HIV 1/2 antibodies).
- History of organ transplant, including allogeneic stem-cell transplantation.
- Known hypersensitivity or severe reaction to any component of study drug(s) or formulation components.
- Presence of a gastrointestinal condition that may affect drug absorption.
- Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study.
- Any condition that would, in the investigator's judgment, interfere with full participation in the study,pose a significant risk to the participant; or interfere with interpretation of study data
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Cedars-Sinai Medical CenterWest Hollywood, California
- University of Maryland-Greenebaum Cancer CenterBaltimore, Maryland
- Dana Farber Cancer InstituteBoston, Massachusetts
- Roswell Park Cancer InstituteBuffalo, New York
- Columbia University Medical CenterNew York, New York
- University of PittsburghPittsburgh, Pennsylvania
- Md Anderson Cancer CenterHouston, Texas
- South Texas Accelerated Research TherapeuticsSan Antonio, Texas
- Cliniques Universitaires Ucl Saint-LucBrussels
- Universitaire Ziekenhuis Leuven - GasthuisbergLeuven
- Institut BergonieBordeaux
- Universitaire Du Cancer de Toulouse Institut Claudius Regaud Iuct-OncopoleToulouse
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jul 11, 2025. Always confirm current availability with the study team.