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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 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.

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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.

Conditions Studied

Advanced Solid Tumor Cervical Cancer Urothelial Carcinoma Metastatic Solid Tumor Clear Cell Renal Cell Cancer (ccRCC) Squamous-Cell Non-Small Cell Lung Cancer

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

FieldValue
Enrollment Target 317 participants
Start Date 2021-08-02
Est. Completion 2028-06-30
Phase Phase 1

Sponsor

GI Innovation

2 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04977453

The ClinicalTrials.gov registry entry for NCT04977453 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 317 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 191-participant average among 189 other Advanced Solid Tumor trials with a reported enrollment target (66% higher). The listed sponsor is GI Innovation, which has 2 total studies on file at ClinicalTrials.gov.

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 reports 8 study locations spanning 6 distinct geographic areas - top geographies include 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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.