Evaluating GI-102 for advanced solid tumors with or without other cancer drugs

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the safety and therapeutic activity of GI-102, a novel bi-specific immunotherapy, both as a standalone treatment and in combination with conventional anti-cancer drugs like pembrolizumab and trastuzumab deruxtecan. It is a phase 1/2, open-label, dose-escalation and expansion study that includes multiple parts focusing on different treatment combinations and dosing strategies. The study aims to assess the drug's pharmacokinetics, tolerability, and anti-tumor effects across various advanced and metastatic solid tumors.

Why it matters

Who can join: the full rules

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

Where it's running

• Mayo Clinic in Arizona
  Scottsdale, Arizona, United States Recruiting
• Mayo Clinic in Florida
  Jacksonville, Florida, United States Recruiting
• Mayo Clinic in Minnesota
  Rochester, Minnesota, United States Recruiting
• Memorial Sloan-Kettering Cancer Center
  New York, New York, United States Recruiting
• Cleveland Clinic
  Cleveland, Ohio, United States Recruiting
• Seoul National University Hospital
  Seoul, Seoul, South Korea Recruiting

Study contacts

• Study coordinator: Jay Kim
• Email: Clinical-102@gi-innovation.com
• Phone: +82-2-404-2003

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• VMD-102 in liver cancer and other solid tumors

  This study tests VMD-102 to see if it is safe and tolerable and to find the best dose for further study in adults with advanced liver cancer and several other solid tumors.

  Recruiting at 2 sites Phase 1/2 VM Discovery, Inc. · Scottsdale, Arizona and 1 other locations · NCT07636785

• GI-108 monotherapy for people with advanced or metastatic solid tumors

  We are testing GI-108 by itself to see if it is safe and can shrink tumors in people with advanced or metastatic solid tumors, including lung, head and neck, and pancreatic cancers.

  Recruiting at 3 sites Phase 1/2 GI Innovation, Inc. · Seoul and 2 other locations · NCT07172802

• JZP898 infusion for advanced metastatic solid tumors

  This study is testing a new treatment called JZP898, alone and with another drug, to see if it can help adults with advanced solid tumors feel better and improve their health.

  Recruiting at 10 sites Phase 1 Jazz Pharmaceuticals · Encinitas, California and 9 other locations · NCT06108050

• Zanzalintinib with immune checkpoint drugs for advanced solid tumors

  This trial will test whether zanzalintinib alone or combined with immune drugs (nivolumab, with or without ipilimumab or relatlimab) is safe and helps people with advanced or metastatic solid tumors such as renal cell, prostate, urothelial, and liver cancers.

  Recruiting at 101 sites Phase 1 Exelixis · Phoenix, Arizona and 121 other locations · NCT05176483

• Evaluating GI-101 with Pembrolizumab, Lenvatinib, or Radiotherapy in Advanced Solid Tumors

  This study is testing a new treatment called GI-101, alone and with other therapies, to see if it can help people with advanced solid tumors.

  Recruiting at 13 sites Phase 1/2 GI Innovation, Inc. · New York, New York and 12 other locations · NCT04977453

• Evaluating PC14586 for advanced solid tumors with a specific mutation

  This study is testing a new oral medication called PC14586 to see if it can help people with advanced solid tumors that have a specific mutation in the TP53 gene.

  Recruiting at 71 sites Phase 1/2 PMV Pharmaceuticals, Inc · Irvine, California and 75 other locations · NCT04585750

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.