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NCT04977453 · ClinicalTrials.gov registry record · Phase 1
GI-101/GI-101A as a Single Agent or in Combination With Pembrolizumab or Lenvatinib in Advanced Solid Tumors
A Phase 1 study of Advanced Solid Tumor and Cervical Cancer, sponsored by GI Innovation.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 317
- Enrollment target
- 8
- Study locations
NCT04977453: Recruiting Phase 1 study of Advanced Solid Tumor and Cervical Cancer, sponsored by GI Innovation.
NCT04977453 is a Phase 1 study of Advanced Solid Tumor and Cervical Cancer that is actively recruiting participants, run by GI Innovation. The registered enrollment target is 317 participants, above the 191-participant average among 189 other Advanced Solid Tumor trials with a reported enrollment target (66% higher). The trial reports 8 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04977453, a Phase 1 study of Advanced Solid Tumor and Cervical Cancer, is actively recruiting participants, sponsored by GI Innovation.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 317 participants
- Enrollment target
- 8
- Study locations
Study Summary
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and therapeutic activity of GI-101/GI-101A as a single agent or in combination with pembrolizumab or lenvatinib over a range of advanced and/or metastatic solid tumors.
Primary Outcome
Dose escalation and optimization phase of Part A, B, and C and Dose escalation phase of Part E and F
Conditions Studied
Interventions
- DRUG Lenvatinib
- DRUG Pembrolizumab (KEYTRUDA®)
- DRUG GI-101
- DRUG GI-101A
Study Locations (8)
Other
- Yonsei University Health System, Severance Hospital - Seoul
- Yonsei University Health System, Severance Hospital - Seoul
- Asan Medical Center - Seoul
New York
- Tisch Cancer Institute (TCI), Icahn School of Medicine - New York
North Carolina
- Carolina Biooncology Institute - Huntersville
Daejeon
- Chungnam National University Hospital - Daejeon
Kyeonggi-do
- The Catholic University of Korea St. Vincent's Hospital - Suwon
Seongbuk-gu
- Korea University Anam Hospital - Seoul
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 317 participants |
| Start Date | 2021-08-02 |
| Est. Completion | 2028-06-30 |
| Phase | Phase 1 |
What NCT04977453 shows while recruiting
NCT04977453 is an interventional study that assigns participants to a tested intervention. The registered 317 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 (66% higher).
The record links to 6 conditions, with Advanced Solid Tumor appearing as the primary indexed condition, and to 4 interventions - of which Lenvatinib is the first listed.
NCT04977453 lists 8 locations in 6 states (Other, New York, North Carolina).
Frequently Asked Questions
What is clinical trial NCT04977453 about?
NCT04977453 is a clinical study titled "GI-101/GI-101A as a Single Agent or in Combination With Pembrolizumab or Lenvatinib in Advanced Solid Tumors". The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and therapeutic activity of GI-101/GI-101A as a single agent or in combination with pembrolizumab or lenvatinib over a range of advanced and/or metastatic solid tumors.
What is the current status of trial NCT04977453?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 317 participants. The study started on 2021-08-02. Estimated completion is 2028-06-30.
What conditions does trial NCT04977453 study?
This clinical trial studies the following conditions: Advanced Solid Tumor, Cervical Cancer, Urothelial Carcinoma, Metastatic Solid Tumor, Clear Cell Renal Cell Cancer (ccRCC).
What interventions are being tested in trial NCT04977453?
The interventions under investigation include: Lenvatinib (DRUG), Pembrolizumab (KEYTRUDA®) (DRUG), GI-101 (DRUG), GI-101A (DRUG).
Who is sponsoring clinical trial NCT04977453?
This trial is sponsored by GI Innovation, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04977453 being conducted?
This trial has 8 study locations across New York, North Carolina, Daejeon, Kyeonggi-do, Seongbuk-gu. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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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 NCT04977453's enrollment target sits among peer trials
317 32nd of 189 higher than 158 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.
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