incb106385 alone or in combination with immunotherapy in advanced solid tumors

Conditions: Ovarian Cancer; Bladder Cancer; Non Small Cell Lung Cancer; Squamous Cell Carcinoma of Head and Neck; Triple Negative Breast Cancer; Castration Resistant Prostate Cancer; Colorectal Cancer; Gastric/ Gastroesophageal Junction; Hepatocellular Carcinoma; Pancreatic Ductal Adenocarcinoma; Squamous Carcinoma of the Anal Canal

Summary: 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)


Eligibility criteria:
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

Keywords: incb106385 advanced solid tumors pd-1