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NCT05163028 · ClinicalTrials.gov registry record · Phase 1
A Dose Escalation Study of SHP2 Inhibitor in Patients With Solid Tumors Harboring KRAS of EGFR Mutations
A Phase 1 study of Cancer and Non-Small Cell Lung Cancer, sponsored by HUYABIO International.
- Active
- Registry status
- Phase 1
- Development phase
- 42
- Enrollment target
- 12
- Study locations
NCT05163028 is a Phase 1 study of Cancer and Non-Small Cell Lung Cancer that is active but no longer recruiting, run by HUYABIO International. The registered enrollment target is 42 participants, below the 3,491-participant average among 615 other Cancer trials with a reported enrollment target (99% lower). The trial reports 12 study locations across 6 states.
The verdict
NCT05163028, a Phase 1 study of Cancer and Non-Small Cell Lung Cancer, is active but no longer recruiting, sponsored by HUYABIO International.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 42 participants
- Enrollment target
- 12
- Study locations
Study Summary
A Phase 1 dose escalation study in patients with advanced solid tumors harboring KRAS or EGFR mutations to determine the maximum tolerated dose and recommended Phase II dose of HBI-2376 and characterize its pharmacokinetic profile.
Conditions Studied
Interventions
- DRUG HBI-2376
Study Locations (12)
California
- City of Hope - Duarte
- California Cancer Associates for Research and Excellence, Inc. (cCare) - Encinitas
- Providence Medical Foundation - Fullerton
- California Cancer Associates for Research and Excellence, Inc. (cCare) - San Marcos
- Sarcoma Oncology - Santa Monica
- UCLA Hematology/Oncology - Santa Monica
Florida
- Orlando Health, Inc. - Orlando
- BRCR Medical Center - Plantation
Ohio
- Gabrail Cancer Center - Canton
Texas
- Texas Oncology - Tyler - Tyler
Virginia
- Virginia Cancer Specialists - Fairfax
Puerto Rico
- Pan American Center for Oncology Trials (PanOncology Trials) - Rio Piedras
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2021-12-13 |
| Est. Completion | 2026-12-31 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05163028
The ClinicalTrials.gov registry entry for NCT05163028 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 42 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 3,491-participant average among 615 other Cancer trials with a reported enrollment target (99% lower). The listed sponsor is HUYABIO International, which has 7 total studies on file at ClinicalTrials.gov.
The record links to 7 conditions, with Cancer appearing as the primary indexed condition, and to 1 intervention - of which HBI-2376 is the first listed.
NCT05163028 reports 12 study locations spanning 6 distinct geographic areas - top geographies include California, Florida, Ohio.
Frequently Asked Questions
What is clinical trial NCT05163028 about?
NCT05163028 is a clinical study titled "A Dose Escalation Study of SHP2 Inhibitor in Patients With Solid Tumors Harboring KRAS of EGFR Mutations". A Phase 1 dose escalation study in patients with advanced solid tumors harboring KRAS or EGFR mutations to determine the maximum tolerated dose and recommended Phase II dose of HBI-2376 and characterize its pharmacokinetic profile.
What is the current status of trial NCT05163028?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 42 participants. The study started on 2021-12-13. Estimated completion is 2026-12-31.
What conditions does trial NCT05163028 study?
This clinical trial studies the following conditions: Cancer, Non-Small Cell Lung Cancer, Colorectal Cancer, Pancreatic Cancer, Solid Tumor.
What interventions are being tested in trial NCT05163028?
The interventions under investigation include: HBI-2376 (DRUG).
Who is sponsoring clinical trial NCT05163028?
This trial is sponsored by HUYABIO International, which has 7 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05163028 being conducted?
This trial has 12 study locations across California, Florida, Ohio, Texas, Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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