A Phase 1, Open-Label, Multicenter Study of INCB106385 as Monotherapy or in Combination With Immunotherapy in Participants With Advanced Solid Tumors

INCB 106385-102

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)

2021-02-03

2024-02-22

2024-02-22

Completed

Early phase I

54

Inclusion Criteria: * 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 Exclusion Criteria: * 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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Open Label'}}, 'enrollmentInfo': {'count': 54, 'type': 'ACTUAL'}}

2024-03-08