Actively Recruiting
Study of GI-102 Alone and with Pembrolizumab or Trastuzumab Deruxtecan in Advanced or Metastatic Solid Tumors
Led by GI Innovation, Inc. · Updated on 2024-11-25
358
Participants Needed
11
Research Sites
75 weeks
Total Duration
On this page
Sponsors
G
GI Innovation, Inc.
Lead Sponsor
M
Merck Sharp & Dohme LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, pharmacokinetics, and therapeutic effects of GI-102, a novel bispecific fusion protein, as a single treatment and in combination with conventional anti-cancer drugs like pembrolizumab or trastuzumab deruxtecan (T-DXd) for advanced or metastatic solid tumors. This phase 1/2, open-label study includes patients with various cancer types including melanoma, breast, colorectal, and others. The study aims to define safe dosing and explore how GI-102 interacts with the immune system to impact tumor growth. The study has four parts: Part A focuses on dose escalation and optimization of GI-102 given intravenously; Part B involves dose escalation and expansion of GI-102 given subcutaneously; Parts C and D explore GI-102 combined with other anti-cancer drugs in specific cancer types. GI-102 is administered either intravenously or by subcutaneous injection every three weeks for up to two years. The combination drugs are given according to their usual schedules alongside GI-102. Participants will undergo regular monitoring for dose-limiting toxicities, adverse events, and immune-related side effects throughout the study and for up to 24 months. Researchers will measure tumor response rates, disease control, survival, and pharmacokinetic properties of GI-102. All participants will have physical exams, laboratory tests, and imaging scans to assess safety and treatment effects during scheduled visits over the course of the trial.
CONDITIONS
Brief Title
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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males and females aged 18 years or older at screening
- Adequate organ and marrow function as defined in protocol
- Measurable disease according to RECIST v1.1 criteria
- ECOG performance status of 0 or 1
- Side effects from prior cancer treatments resolved to Grade 1 or less, except alopecia and Grade 2 peripheral neuropathy
- HIV-infected patients on antiretroviral therapy with well-controlled infection
You will not qualify if you...
- Known active central nervous system metastases or carcinomatous meningitis
- Active second malignancy
- Active or history of Hepatitis B or active Hepatitis C infection
- Active tuberculosis or history of active tuberculosis
- Active or uncontrolled infections within 4 weeks before treatment
- Chronic liver disease or hepatic cirrhosis except in patients with liver metastasis
- Active autoimmune disease requiring systemic treatment within past 2 years
- Prior immunotherapies similar to GI-102's mode of action
- Diagnosis of immunodeficiency or recent use of immunosuppressive medications within 2 weeks before treatment
- Systemic anti-cancer therapy including investigational agents within 4 weeks before treatment
- Radiotherapy within 2 weeks before treatment except limited palliative radiotherapy
- Live attenuated vaccine within 4 weeks before treatment
- Known hypersensitivity to GI-102 components or excipients
- Other protocol-defined criteria may apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 years (approximately 35 cycles)
Participants receive GI-102 as a single agent or in combination with other anti-cancer drugs through intravenous or subcutaneous administration according to their assigned cohort.
Visits every 3 weeks for GI-102 administration; additional weekly or biweekly visits depending on combination drugs
Duration - Up to approximately 24 months after treatment
Participants are monitored for safety and therapeutic effects after completing treatment.
Periodic visits as scheduled for assessment of adverse events and tumor response
Trial Site Locations
Total: 11 locations
1
Mayo Clinic in Arizona
Scottsdale, Arizona, United States, 85259
Actively Recruiting
2
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224
Actively Recruiting
3
Mayo Clinic in Minnesota
Rochester, Minnesota, United States, 55905
Actively Recruiting
4
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
5
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
6
Seoul National University Hospital
Seoul, Seoul, South Korea, 03080
Actively Recruiting
7
St. Vincent's Hospital
Suwon, suwon, South Korea, 12647
Actively Recruiting
8
Yonsei University Health System, Severance Hospital
Seoul, South Korea, 03722
Actively Recruiting
9
Yonsei University Health System, Severance Hospital
Seoul, South Korea, 03722
Actively Recruiting
10
Asan Medical Center
Seoul, South Korea, 05505
Actively Recruiting
11
Samsung Medical Center
Seoul, South Korea, 06351
Actively Recruiting
Research Team
J
Jay Kim
W
Woosun Lee
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
7
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