study of gs-4528 in adults with solid tumors

Conditions: Solid Tumor

Summary: the goals of this clinical study are to identify if gs-4528 alone or in combination with anti-programmed cell death protein 1 (pd-1) (anti-pd-1) monoclonal antibody is safe and tolerable in people with solid tumors and to identify the recommended dose of gs-4528 for further development that is safe to give to people alone or in combination with anti-pd-1 monoclonal antibody. the primary objectives of this study are: * to assess the safety and tolerability of gs-4528 as monotherapy and in combination with anti-pd-1 monoclonal antibody in participants with advanced solid tumors. * to identify the maximum tolerated dose (mtd)/maximum administered dose (mad) and/or the recommended phase 2 dose (rp2d) of gs-4528 as monotherapy and in combination with anti-pd-1 monoclonal antibody in participants with advanced solid tumors.


Eligibility criteria:
key inclusion criteria: * documented disease: * phase 1a dose escalation and backfill cohorts; phase 1b dose escalation: individuals with histologically or cytologically confirmed advanced solid tumors who have received, been intolerant to, or been ineligible for all treatment known to confer clinical benefit or have a contraindication to receive the therapy. * phase 1a dose expansion: individuals with histologically or cytologically confirmed select indications who have received, been intolerant to, or been ineligible for all treatment known to confer clinical benefit or have a contraindication to receive the therapy. * eastern cooperative oncology group performance status 0 or 1. * measurable disease per response evaluation criteria in solid tumors (recist) v1.1 criteria. * adequate organ function. * individuals of childbearing potential who engage in heterosexual intercourse must agree to use method(s) of contraception. * tissue requirements: * phase 1a dose escalation, phase 1a dose expansion, and phase 1b dose escalation: must provide pre-treatment adequate tumor tissue sample prior to enrolment. * phase 1a backfill cohorts: individuals must have fresh pre-treatment and on-treatment biopsy for biomarker analysis. * life expectancy ≥ 3 months. key exclusion criteria: * positive serum pregnancy test or lactating female. * prohibited concurrent anticancer therapy listed in the protocol. * any anti-cancer therapy, whether investigational or approved, within protocol specified time prior to initiation of study including: major surgery (\<28 days), immunotherapy or biologic therapy (\< 28 days), chemotherapy (\< 21 days), targeted small molecule therapy (\< 14 days or \< 5 half-lives whichever is shorter), hormonal therapy or other adjunctive therapy (\< 14 days) or radiotherapy (\< 21 days). * any prior allogeneic tissue/solid organ transplantation, including allogeneic stem cell transplantation. * diagnosis of immunodeficiency, either primary or acquired, or systemic steroid requirement of \> 10 mg of prednisone or equivalent. * history of intolerance, hypersensitivity, or treatment discontinuation due to severe immune-related adverse events (iraes) on prior immunotherapy. * history of autoimmune disease or active autoimmune disease that has required systemic treatment within 2 years prior to the start of study treatment. * concurrent active second malignancy. note: individuals with a history of malignancy that have been completely treated, with no evidence of active cancer for 2 years prior to enrollment, or participants with surgically cured tumors with low risk of recurrence are allowed to enroll. * have known active central nervous system (cns) metastases and/ or carcinomatous meningitis. * significant cardiovascular disease. * have active serious infection requiring antibiotics. * have active hepatitis b virus (hbv), hepatitis c virus (hcv), or human immunodeficiency virus (hiv). * history of pneumonitis, interstitial lung disease, or severe radiation pneumonitis (excluding localized radiation pneumonitis). * symptomatic ascites or pleural effusion. * live vaccines within 28 days of initiation of investigational product(s). note: other protocol defined inclusion/exclusion criteria may apply.