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NCT05824975 · ClinicalTrials.gov registry record · Phase 1
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)
A Phase 1 study of Advanced Solid Tumor and Metastatic Solid Tumor, sponsored by GI Innovation.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 358
- Enrollment target
- 11
- Study locations
NCT05824975: Recruiting Phase 1 study of Advanced Solid Tumor and Metastatic Solid Tumor, sponsored by GI Innovation.
NCT05824975 is a Phase 1 study of Advanced Solid Tumor and Metastatic Solid Tumor that is actively recruiting participants, run by GI Innovation. The registered enrollment target is 358 participants, above the 191-participant average among 189 other Advanced Solid Tumor trials with a reported enrollment target (87% higher). The trial reports 11 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05824975, a Phase 1 study of Advanced Solid Tumor and Metastatic Solid Tumor, is actively recruiting participants, sponsored by GI Innovation.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 358 participants
- Enrollment target
- 11
- Study locations
Study Summary
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.
Primary Outcome
A DLT is defined as a clinically significant AE (classified according to the NCI CTCAE version 5) or significant laboratory abnormality that occur during the DLT assessment periods, during dose escalation and dose expansion, and is considered by the Investigator to be related to GI-102.
Conditions Studied
Interventions
- DRUG bevacizumab
- DRUG GI-102 subcutaneous (SC)
- DRUG GI-102
- DRUG doxorubicin
- DRUG paclitaxel
Study Locations (11)
Other
- Yonsei University Health System, Severance Hospital - Seoul
- Yonsei University Health System, Severance Hospital - Seoul
- Asan Medical Center - Seoul
- Samsung Medical Center - Seoul
Arizona
- Mayo Clinic in Arizona - Scottsdale
Florida
- Mayo Clinic in Florida - Jacksonville
Minnesota
- Mayo Clinic in Minnesota - Rochester
New York
- Memorial Sloan-Kettering Cancer Center - New York
Ohio
- Cleveland Clinic - Cleveland
Seoul
- Seoul National University Hospital - Seoul
suwon
- St. Vincent's Hospital - Suwon
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 358 participants |
| Start Date | 2023-05-30 |
| Est. Completion | 2027-04-24 |
| Phase | Phase 1 |
What NCT05824975 shows while recruiting
NCT05824975 is an interventional study that assigns participants to a tested intervention. The registered 358 participants enrollment target is mid-sized for trials with a published cap, above the 191-participant average among 189 other Advanced Solid Tumor trials with a reported enrollment target (87% higher).
The record links to 9 conditions, with Advanced Solid Tumor appearing as the primary indexed condition, and to 5 interventions - of which bevacizumab is the first listed.
NCT05824975 lists 11 locations in 8 states (Other, Arizona, Florida).
Frequently Asked Questions
What is clinical trial NCT05824975 about?
NCT05824975 is a clinical study titled "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)". 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.
What is the current status of trial NCT05824975?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 358 participants. The study started on 2023-05-30. Estimated completion is 2027-04-24.
What conditions does trial NCT05824975 study?
This clinical trial studies the following conditions: Advanced Solid Tumor, Metastatic Solid Tumor, HER2-Negative Breast Cancer, Cutaneous Melanoma, Colorectal Cancer (CRC).
What interventions are being tested in trial NCT05824975?
The interventions under investigation include: bevacizumab (DRUG), GI-102 subcutaneous (SC) (DRUG), GI-102 (DRUG), doxorubicin (DRUG), paclitaxel (DRUG).
Who is sponsoring clinical trial NCT05824975?
This trial is sponsored by GI Innovation, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05824975 being conducted?
This trial has 11 study locations across Arizona, Florida, Minnesota, New York, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Advanced Solid Tumor
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05824975's enrollment target sits among peer trials
358 22nd of 189 higher than 167 of 189 other Advanced Solid Tumor trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Advanced Solid Tumor trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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