Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT05485974 · ClinicalTrials.gov registry record · Phase 1
A Dose Escalation Study of HBI-2438 in Patients With Solid Tumors Harboring KRAS G12C Mutation
A Phase 1 study of Cancer and Non-Small Cell Lung Cancer, sponsored by HUYABIO International.
- Active
- Registry status
- Phase 1
- Development phase
- 44
- Enrollment target
- 14
- Study locations
NCT05485974: Active Phase 1 study of Cancer and Non-Small Cell Lung Cancer, sponsored by HUYABIO International.
NCT05485974 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 44 participants, below the 3,491-participant average among 615 other Cancer trials with a reported enrollment target (99% lower). The trial reports 14 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05485974, 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
- 44 participants
- Enrollment target
- 14
- Study locations
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.
Primary Outcome
Safety endpoints: Incidence of dose-limiting toxicities (DLTs)
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 |
What the registry record for NCT05485974 still lists
NCT05485974 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 44 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-2438 is the first listed.
NCT05485974 lists 14 locations in 6 states (California, Florida, Michigan).
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, Non-Small Cell Lung Cancer, Lung Cancer, Colorectal Cancer, Solid Tumor.
What interventions are being tested in trial NCT05485974?
The interventions under investigation include: HBI-2438 (DRUG).
Who is sponsoring clinical trial NCT05485974?
This trial is sponsored by HUYABIO International, which has 7 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Cancer
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 NCT05485974's enrollment target sits among peer trials
44 449th of 615 higher than 162 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.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Development of Radiation Free Whole Body Magnetic Resonance (MR) Imaging Technique for Staging Children With Cancer
RECRUITING · Phase 1
-
A Study of OR502, a Monoclonal Antibody Targeting LILRB2, Alone and in Combination With Anticancer Agents
RECRUITING · Phase 1
-
A Phase 1 Study of CPO301 in Adult Patients With Advanced or Metastatic Solid Tumors
RECRUITING · Phase 1
-
Impact of Daily Oral Cannabis Doses in Patients With Cancer
RECRUITING · Phase 1
-
A Study Assessing KB707 for the Treatment of Locally Advanced or Metastatic Solid Tumors
RECRUITING · Phase 1
-
Safety, PK, and Preliminary Efficacy of MBRC-101 in Advanced Refractory Solid Tumors
RECRUITING · Phase 1
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02323945 · 44 participants · NA
Effects of Breathing Mild Bouts of Low Oxygen on Limb Mobility After Spinal Injury
- NCT03093909 · 44 participants · Phase 1
Study of Aerosol Gemcitabine in Patients With Solid Tumors and Pulmonary Metastases
- NCT03104491 · 44 participants · Phase 1
Inotuzumab Ozogamicin Post-Transplant For Acute Lymphocytic Leukemia
- NCT03781765 · 44 participants · Phase 4
Stimulant vs. Non-stimulant Treatments and Reward Processing in Drug-naive Youth at SUD Risk
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI