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

• Status: Recruiting
• Trial end date: 2025-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and therapeutic activity of GI-101 as a single agent or in combination with pembrolizumab, lenvatinib or local radiotherapy (RT) over a range of advanced and/or metastatic solid tumors.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GI Innovation, Inc.
• Collaborator: Merck Sharp & Dohme Corp.
• Treatments: Lenvatinib; Pembrolizumab

Criteria

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