OncoMatch/Clinical Trials/NCT05824975
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)
Is NCT05824975 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1/2 trial studies multiple treatments for advanced solid tumor.
Treatment: GI-102 subcutaneous (SC) · GI-102 · doxorubicin · paclitaxel · bevacizumab · eribulin · trastuzumab deruxtecan (T-DXd) · pembrolizumab · GI-102 — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Targeted therapy
Chemotherapy
Other
Cancer type
Tumor Agnostic
Sarcoma
Ovarian Cancer
Hepatocellular Carcinoma
Colorectal Cancer
Breast Carcinoma
Melanoma
Renal Cell Carcinoma
Disease stage
Metastatic disease required
Metastatic Solid Tumor
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: immunotherapy related to mode of action of GI-102
Previous immunotherapies related to mode of action of GI-102.
Cannot have received: systemic anti-cancer therapy
Exception: within 4 weeks prior to treatment
Administration of prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to treatment.
Cannot have received: radiotherapy
Exception: within the last 2 weeks before start of study treatment administration, with exception of limited field palliative radiotherapy
Radiotherapy within the last 2 weeks before start of study treatment administration, with exception of limited field palliative radiotherapy.
Lab requirements
Blood counts
as defined in protocol
Kidney function
as defined in protocol
Liver function
as defined in protocol
Has adequate organ and marrow function as defined in protocol.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Mayo Clinic in Arizona · Scottsdale, Arizona
- Mayo Clinic in Florida · Jacksonville, Florida
- Mayo Clinic in Minnesota · Rochester, Minnesota
- Memorial Sloan-Kettering Cancer Center · New York, New York
- Cleveland Clinic · Cleveland, Ohio
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT05824975 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior immunotherapy related to mode of action of GI-102, systemic anti-cancer therapy, radiotherapy disqualifies patients from enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify