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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 (May 2026). This Phase 1/2 trial studies multiple treatments for advanced solid tumor.

Phase 1/2RecruitingGI Innovation, Inc.NCT05824975Data as of May 2026

Treatment: GI-102 subcutaneous (SC) · GI-102 · doxorubicin · paclitaxel · bevacizumab · eribulin · trastuzumab deruxtecan (T-DXd) · pembrolizumab · GI-102The 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.

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Extracted eligibility criteria

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 →

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