The primary objectives of this study are to characterize the safety and tolerability of
GS-3583 as monotherapy, and to determine the maximum tolerated dose (MTD) or recommended
Phase 2 dose (RP2D) of GS-3583 as monotherapy in participants with advanced solid tumors.
Key Inclusion Criteria:
- Histologically or cytologically confirmed locally advanced or metastatic malignant
solid tumor that is refractory to or intolerant of standard therapy or for which no
standard therapy is available
- Have measurable disease on imaging based on Response Evaluation Criteria in Solid
Tumors Version 1.1 (RECIST 1.1)
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
- Life expectancy of ≥ 3 months, in the opinion of the investigator
- Adequate organ function as assessed by hematological, renal, and hepatic parameters,
and no clinically significant coagulopathy
Key Exclusion Criteria:
- Received prior systemic cytotoxic chemotherapy, biological therapy, radiotherapy, or
major surgery within 3 weeks of Cycle 1 Day 1; a 1-week washout is permitted for
palliative radiation to non-central nervous system (CNS) disease with sponsor approval
- Known severe hypersensitivity reactions (NCI CTCAE Grade ≥ 3) to fully human
monoclonal antibodies or fusion proteins, GS-3583 formulation excipients, or severe
reaction to immuno-oncology agents, such as colitis or pneumonitis requiring treatment
with corticosteroids, any history of anaphylaxis, or uncontrolled asthma
- Concurrent active malignancy other than nonmelanoma skin cancer, carcinoma in situ of
the cervix, or superficial bladder cancer who has undergone potentially curative
therapy with no evidence of disease. Individuals with other previous malignancies are
eligible if disease free for > 2 years.
- Previous history of hematological malignancy, monoclonal gammopathy of unknown
significance (MGUS) or other preleukemic states (Presence of clonal hematopoiesis of
indeterminate potential (CHIP)/age related clonal hematopoiesis (ARCH) is acceptable)
- Known CNS metastasis(es), unless metastases are treated and stable and the individual
does not require systemic corticosteroids for management of CNS symptoms at least 1
week prior to study treatment. Individuals with history of carcinomatous meningitis
are excluded regardless of clinical stability.
- Active or history of autoimmune disease that has required systemic treatment within 2
years of the start of study treatment (ie, with use of disease-modifying agents,
corticosteroids, or immunosuppressive drugs)
- Note: Individuals with diabetes type 1, vitiligo, psoriasis, hypothyroid disease,
or hyperthyroid disease, not requiring immunosuppressive treatment are eligible.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.