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RECRUITINGPhase 1 / Phase 2INTERVENTIONAL

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)

An Open-label, Multicenter, Dose Escalation and Expansion Phase 1/2 Study to Evaluate the Safety, Tolerability and Pharmacokinetics, and Anti-tumor Activity of GI-102, a CD80-IgG4 Fc-IL-2v Bispecific Fusion Protein, As a Single Agent and in Combination with Conventional Anti-cancer Drugs, Pembrolizumab or Trastuzumab Deruxtecan(T-DXd) in Patients with Advanced or Metastatic Solid Tumors (KEYNOTE-G08)

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and therapeutic activity of GI-102 as a single agent and in combination with conventional anti-cancer drugs, pembrolizumab or trastuzumab deruxtecan(T-DXd) over a range of advanced and/or metastatic solid tumors.

Who May Be Eligible (Plain English)

Key Who May Qualify: - 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. - You should be able to carry out daily activities with 0 level of ability (ECOG 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 Who Should NOT Join This Trial: - Has known active cancer that has spread to the brain 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 conditions (where your immune system attacks your own body) that has required systemic treatment in past 2 years. - Previous immunotherapies related to mode of action of GI-102. - Has a diagnosis of weakened immune system 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. - Administration of a live, attenuated vaccine within 4 weeks before Cycle 1 Day 1. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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-102. * 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. * 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-102. Other protocol defined inclusion exclusion criteria may apply

Treatments Being Tested

DRUG

GI-102 subcutaneous (SC)

0.12 mg/kg, 0.24 mg/kg or Recommended phase 2 dose of GI-102 will be administered via SC injection Q3W up to 2 years (approximately 35 years).

DRUG

GI-102

Dose level will be escalated from 0.06 mg/kg to 0.45 mg/kg and Recommended phase 2 dose (or RP2D-1, RP2D+1) of GI-102 will be administered via IV infusion Q3W up to 2 years (approximately 35 years).

DRUG

doxorubicin

Doxorubicin will be administered intravenously at a dose of 75 mg/m2 on Day 3 every 3-week (21-day) cycle for up to 6 cycles.

DRUG

paclitaxel

Paclitaxel will be administered intravenously over 1 hour at a dose of 80 mg/m2 each time weekly as a diluted solution according to the prescribing information.

DRUG

bevacizumab

Bevacizumab will be administered intravenously at a dose of 10 mg/kg every 2 weeks.

DRUG

eribulin

Eribulin will be administered intravenously at a dose of over 1.4 mg/m2 over 2 to 5 minutes on Days 3 and 10 every 3-week (21-day) cycle.

DRUG

trastuzumab deruxtecan (T-DXd)

T-DXd will be administered initially as a 5.4 mg/kg (or 6.4 mg/kg only for gastric cancer) IV over 30 - 90 minutes every 3 weeks.

DRUG

pembrolizumab

pembrolizumab will be administered at a dose of 200 mg as IV infusion Q3W.

DRUG

GI-102

Recommended phase 2 dose (or RP2D-1, RP2D-2) of GI-102 will be administered via IV infusion Q3W up to 2 years (approximately 35 years).

Locations (11)

Mayo Clinic in Arizona
Scottsdale, Arizona, United States
Mayo Clinic in Florida
Jacksonville, Florida, United States
Mayo Clinic in Minnesota
Rochester, Minnesota, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
Cleveland Clinic
Cleveland, Ohio, United States
Seoul National University Hospital
Seoul, Seoul, South Korea
St. Vincent's Hospital
Suwon, suwon, South Korea
Yonsei University Health System, Severance Hospital
Seoul, South Korea
Yonsei University Health System, Severance Hospital
Seoul, South Korea
Asan Medical Center
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea