Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of GS-9716 as Monotherapy and in Combination With Anticancer Therapies in Adults With Solid Malignancies

Inclusion Criteria

• •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• •Measurable disease per RECIST version 1.1
• •Adequate hematology, renal and hepatic function
• •Left ventricular ejection fraction (LVEF) ≥ 50%
• •Patients with brain metastases may be enrolled only if treated, nonprogressive, asymptomatic and not taking high dose steroids for at least 4 weeks prior to Cycle 1 Day 1 (C1D1)
• •Individuals of childbearing potential who engage in heterosexual intercourse must agree to use method(s) of contraception, per protocol.
• •Tissue criteria: must provide sufficient, and adequate tumor tissue sample or agree to have a biopsy taken.
• •Histologically or cytologically confirmed locally advanced or metastatic malignant solid tumor for which no standard therapy is available, standard therapy has failed, or for whom standard-of-care therapy is contraindicated.
• •Histologically or cytologically confirmed unresectable metastatic or locally advanced disease following treatment for metastatic disease including an immune checkpoint inhibitor and a platinum-containing chemotherapy
• •Patients with actionable genomic alterations must have also received treatment with at least 1 approved therapy appropriate to the genomic alteration unless unavailable or contraindicated
• •Histologically or cytologically confirmed disease based on the most recent analyzed biopsy metastatic disease that is refractory to or relapsed after at least 2 prior standard-of-care chemotherapy regimens, one of which was a taxane (unless contraindicated).