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

Key Inclusion Criteria:

General Inclusion Criteria (all cohorts):

• 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 1Day 1 (C1D1)

• Individuals of childbearing potential who engage in heterosexual intercourse mustagree to use method(s) of contraception, per protocol.

• Tissue criteria: must provide sufficient, and adequate tumor tissue sample or agreeto have a biopsy taken.

Part A Specific Inclusion Criteria: zamzetoclax as monotherapy

• Histologically or cytologically confirmed locally advanced or metastatic malignantsolid tumor for which no standard therapy is available, standard therapy has failed,or for whom standard-of-care therapy is contraindicated.

Cohorts B1 and C1 Specific Inclusion Criteria:

• Histologically or cytologically confirmed unresectable metastatic or locallyadvanced disease following treatment for metastatic disease including an immunecheckpoint inhibitor and a platinum-containing chemotherapy

• Patients with actionable genomic alterations must have also received treatment withat least 1 approved therapy appropriate to the genomic alteration unless unavailableor contraindicated

Cohorts B4 and C4 Specific Inclusion Criteria:

• Histologically or cytologically confirmed disease based on the most recent analyzedbiopsy metastatic disease that is refractory to or relapsed after at least 2 priorstandard-of-care chemotherapy regimens, one of which was a taxane (unlesscontraindicated).

Key Exclusion Criteria:

• Prior systemic anti-cancer therapy must meet wash-out criteria outlined in protocol

• Treatment with any high dose systemic corticosteroids or nonsystemic radiotherapywithin 2 weeks of the first dose of zamzetoclax (low dose corticosteroidspermitted).

• Women who are pregnant or lactating

• Patients with active ≥ Grade 2 nausea or vomiting, and/or signs of intestinalobstruction

• Known active or chronic hepatitis B or C infection or HIV infection/ HIV positive

• Known history of clinically significant cardiovascular disease or heart failure.

• Known history of clinically significant active chronic obstructive pulmonary diseaseor other moderate to severe chronic respiratory illness present within 6 monthsprior to C1D1

• Known history of other clinically significant pulmonary disease or evidence ofactive pneumonitis

• Uncontrolled pleural effusion, pericardial effusion, or ascites

• History of clinically significant bleeding, intestinal obstruction, orgastrointestinal (GI) perforation within 6 months prior to C1D1

• Infection requiring intravenous anti-infective use within 2 weeks prior to C1D1

• Active or history of autoimmune disease or immune deficiency

• History of uncured coexisting cancer, not including uncured basal cell carcinoma,cervical cancer in situ, or superficial bladder cancer.

Cohort A Specific Exclusion Criteria: zamzetoclax as monotherapy:

• Known heart failure or elevated cardiac biomarkers

Cohorts B1 and C1 Specific Exclusion Criteria:

• Known hypersensitivity to excipients in study treatments.

Cohorts B4 and C4 Specific Exclusion Criteria:

• Prior treatment with sacituzumab govitecan-hziy or a topoisomerase 1 inhibitor oragents targeting Trop-2.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.