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A Dose Escalation Study of HBI-2438 in Patients With Solid Tumors Harboring KRAS G12C Mutation
NCT05485974 · View on ClinicalTrials.gov ↗
Study Summary
A Phase 1 dose escalation study in patients with advanced solid tumors harboring KRAS G12C mutation to determine the maximum tolerated dose and recommended Phase II dose of HBI-2438 and characterize its pharmacokinetic profile.
Conditions Studied
Interventions
- DRUG HBI-2438
Study Locations (14)
California
- California Cancer Associates for Research and Excellence, Inc. (cCare) — Encinitas
- The Oncology Institute of Hope and Innovation — Glendale
- The Oncology Institute of Hope and Innovation — Long Beach
- The Oncology Institute of Hope and Innovation — Pasadena
- California Cancer Associates for Research and Excellence, Inc. (cCare) — San Marcos
- The Oncology Institute of Hope and Innovation — Santa Ana
- Sarcoma Oncology — Santa Monica
- Innovative Clinical Research Institute (ICRI) — Whittier
- The Oncology Institute of Hope and Innovation — Whittier
Florida
- BRCR Medical Center — Plantation
Michigan
- Michigan Center of Medical Research — Farmington Hills
Missouri
- Alliance for Multispecialty Research, LLC — Kansas City
Ohio
- Gabrail Cancer Center — Canton
Puerto Rico
- Pan American Center for Oncology Trials (PanOncology Trials) — Rio Piedras
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2022-08-01 |
| Est. Completion | 2026-12-31 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05485974
The ClinicalTrials.gov registry entry for NCT05485974 describes a study currently listed as active not recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 44 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is HUYABIO International, which has 4 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 7 conditions, with Cancer appearing as the primary indexed condition, and to 1 intervention — of which HBI-2438 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05485974 reports 14 study locations spanning 6 distinct geographic areas — top geographies include California, Florida, Michigan. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05485974 about?
NCT05485974 is a clinical study titled "A Dose Escalation Study of HBI-2438 in Patients With Solid Tumors Harboring KRAS G12C Mutation". A Phase 1 dose escalation study in patients with advanced solid tumors harboring KRAS G12C mutation to determine the maximum tolerated dose and recommended Phase II dose of HBI-2438 and characterize its pharmacokinetic profile.
What is the current status of trial NCT05485974?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 44 participants. The study started on 2022-08-01. Estimated completion is 2026-12-31.
What conditions does trial NCT05485974 study?
This clinical trial studies the following conditions: Cancer, Lung Cancer, Colorectal Cancer, Solid Tumor, Non Small Cell Lung Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05485974?
The interventions under investigation include: HBI-2438 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05485974?
This trial is sponsored by HUYABIO International, which has 4 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05485974 being conducted?
This trial has 14 study locations across California, Florida, Michigan, Missouri, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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