Brief Title: GI-101 as a Single Agent or in Combination With Pembrolizumab, Lenvatinib or Local Radiotherapy in Advanced Solid Tumors

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Incidence and nature of Dose-Limiting Toxicity (DLTs)

Primary Outcome 1 - Timeframe: Study Day 1, assessed up to approximately 24 months

Primary Outcome 2 - Measure: Incidence, nature, and severity of adverse events (AEs) and immune-related AEs (irAEs)

Primary Outcome 2 - Timeframe: Study Day 1, assessed up to approximately 24 months

Primary Outcome 3 - Measure: Objective Response Rate (ORR) according to RECIST version 1.1

Primary Outcome 3 - Timeframe: Study Day 1, assessed up to approximately 24 months

CONDITION

• Advanced Solid Tumor
• Metastatic Solid Tumor
• Non-small Cell Lung Cancer
• Head and Neck Squamous Cell Carcinoma
• Renal Cell Carcinoma
• Urinary Bladder Cancer
• Melanoma
• Sarcoma
• Microsatellite Stable Colorectal Carcinoma
• Merkel Cell Carcinoma
• Esophageal Squamous Cell Carcinoma
• Cervical Cancer
• Vaginal Cancer
• Vulvar Cancer

ELIGIBILITY

Key Inclusion Criteria:
* Males and females aged ≥ 18 years (or ≥ 19 years according to local regulatory guidelines) 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, other prior 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 a well-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 virus infection.

- * Has active tuberculosis or has a known history of active tuberculosis

- * Active or uncontrolled infections, or severe infection within 4 weeks before study treatment administration.

- * History of chronic liver disease or evidence of hepatic cirrhosis, except patients with liver metastasis.

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

- * Previous immunotherapies related to mode of action of GI-101.

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

- * Administration of prior systemic anti-cancer therapy including investigational agents 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 (except Part D).

- * 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/or excipients of GI-101, pembrolizumab or lenvatinib.
Other protocol defined inclusion exclusion criteria may apply

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Nari Yun, PhD

Role: Study Director

Affiliation: GI Innovation

Overall Contact

Name: Nari Yun, PhD

Phone: +82-2-404-2003

Email: clinical@gi-innovation.com

LOCATION