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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: Active Phase 1 study of Cancer and Non-Small Cell Lung Cancer, sponsored by HUYABIO International.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Safety endpoints: Incidence of dose-limiting toxicities (DLTs), adverse events (AEs), and serious adverse events (SAEs) overall, by severity, by relationship to HBI-2376, and those that led to discontinuation of HBI-2376
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 |
What the registry record for NCT05163028 still lists
NCT05163028 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 42 participants, a relatively small participant target, below the 3,491-participant average among 615 other Cancer trials with a reported enrollment target (99% lower).
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 lists 12 locations in 6 states (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.
Learn More About Clinical Trials
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Where NCT05163028's enrollment target sits among peer trials
42 457th of 615 higher than 157 of 615 other Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cancer 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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