A Study to Evaluate the Safety and Therapeutic Activity of GI-102 As a Single Agent and in Combination with Conventional Anti-cancer Drugs, Pembrolizumab or Trastuzumab Deruxtecan(T-DXd) in Patients with Advanced Solid Tumors (KEYNOTE-G08)

Key Inclusion Criteria:

• Males and females aged ≥ 18 years (or ≥ 19 years according to local regulatoryguidelines) at the time of screening.

• Has adequate organ and marrow function as defined in protocol.

• Measurable disease as per RECIST v1.1.

• ECOG performance status 0-1.

• Adverse events related to any prior chemotherapy, radiotherapy, immunotherapy, otherprior systemic anti-cancer therapy, or surgery must have resolved to Grade ≤1,except alopecia and Grade 2 peripheral neuropathy.

• HIV infected patients must be on anti-retroviral therapy (ART) and have awell-controlled HIV infection/disease as defined in protocol.

Key Exclusion Criteria:

• Has known active CNS metastases and/or carcinomatous meningitis.

• An active second malignancy.

• Has active or a known history of Hepatitis B or known active Hepatitis C virusinfection.

• Has active tuberculosis or has a known history of active tuberculosis.

• Active or uncontrolled infections, or severe infection within 4 weeks before studytreatment administration.

• History of chronic liver disease or evidence of hepatic cirrhosis, except patientswith liver metastasis.

• Has an active autoimmune disease that has required systemic treatment in past 2years.

• Previous immunotherapies related to mode of action of GI-102.

• Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapyor any other form of immunosuppressive medications within 2 weeks prior to Cycle 1Day 1.

• Administration of prior systemic anti-cancer therapy including investigationalagents within 4 weeks prior to treatment.

• Radiotherapy within the last 2 weeks before start of study treatment administration,with exception of limited field palliative radiotherapy.

• Administration of a live, attenuated vaccine within 4 weeks before Cycle 1 Day 1.

• Known hypersensitivity to any of the components of the drug products and/orexcipients of GI-102.

Other protocol defined inclusion exclusion criteria may apply