Breast Cancer Clinical Trial
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)
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.
Inability to swallow food or any condition of the upper gastrointestinal tract that precludes administration of oral medications.
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
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There are 28 Locations for this study
West Hollywood California, 90048, United States
Baltimore Maryland, 21201, United States
Boston Massachusetts, 02215, United States
Buffalo New York, 14263, United States
New York New York, 10032, United States
Pittsburgh Pennsylvania, 15232, United States
Houston Texas, 77030, United States
San Antonio Texas, 78229, United States
Brussels , 01200, Belgium
Leuven , 03000, Belgium
Bordeaux , 33000, France
Toulouse , 31059, France
Villejuif , 94800, France
Modena , 41124, Italy
Naples , 80131, Italy
Rozzano , 20089, Italy
Verona , 37134, Italy
Barcelona , 08035, Spain
Madrid , 28040, Spain
Madrid , 28041, Spain
Madrid , 28050, Spain
Pamplona , 31008, Spain
Cambridge , CB2 0, United Kingdom
Glasgow , G12 0, United Kingdom
London , SE1 9, United Kingdom
London , W12 0, United Kingdom
Manchester , M20 4, United Kingdom
Newcastle Upon Tyne , NE7 7, United Kingdom
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