Testing a new drug for patients with solid tumors and specific genetic mutations
A Phase 1, Open-Label, Dose Escalation of HBI-2376 in Patients With Advanced Malignant Solid Tumors Harboring KRAS or EGFR Mutations
This study is testing a new drug called HBI-2376 to see if it can safely help patients with advanced solid tumors that have specific genetic mutations.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 42 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | HUYABIO International, LLC. Industry-sponsored |
| Drugs / interventions | prednisone |
| Locations | 12 sites (Duarte, California and 11 other locations) |
| Trial ID | NCT05163028 on ClinicalTrials.gov |
What this trial studies
This Phase 1, open-label dose escalation study evaluates the safety and pharmacokinetics of HBI-2376, a SHP2 inhibitor, in patients with advanced solid tumors harboring KRAS or EGFR mutations. The study aims to determine the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D) of HBI-2376, administered once daily. Up to 42 participants will be enrolled sequentially into cohorts receiving escalating doses, and their safety and tolerability will be closely monitored throughout the trial.
Who should consider this trial
Good fit: Ideal candidates include adults with advanced solid tumors harboring KRAS or EGFR mutations who have not responded to standard therapies.
Not a fit: Patients with concurrent malignancies or those who have not been diagnosed with KRAS or EGFR mutations may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option for patients with advanced solid tumors that have specific genetic mutations.
How similar studies have performed: Other studies targeting KRAS and EGFR mutations have shown promise, indicating potential for success with this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Key Inclusion Criteria: * Male or female at least 18 years of age at the time of signing the ICF prior to initiation of any study specific activities/procedures * Advanced malignant solid tumors with KRAS or EGFR mutations diagnosed by histology or cytology * Relapsed or refractory to, or intolerant of, or refuse approved or standard of care established therapy known to provide clinical benefit for disease * At least 1 measurable target lesion that meets the definition of RECIST v1.1 * ECOG Performance Status of 0 or 1 * Demonstrate adequate organ function * Must be able to swallow oral medications and must not have gastrointestinal abnormalities that significantly affect drug absorption Key Exclusion Criteria: * History of another concurrent malignancy within 3 years prior to study entry, unless the malignancy was treated with curative intent and the likelihood of relapse is \<5% in 2 years Note: Subjects with a history of squamous or basal cell carcinoma of the skin or carcinoma in the situ of the cervix may be enrolled * Untreated or symptomatic central nervous system (CNS) metastases Note: Subjects with asymptomatic treated CNS metastases are eligible provided they have been clinically stable and not requiring steroids for at least 4 weeks * Clinically significant cardiovascular disease, including stroke or myocardial infarction within 6 months * Any unresolved Grade 2 or greater toxicity from previous anti-cancer therapy, except alopecia, within 4 weeks of first study treatment administration * Active autoimmune diseases or history of autoimmune diseases that may relapse * Pregnant or nursing * Prior treatment with any SHP2 inhibitors * Any condition that required systemic treatment with either corticosteroids (\>10 mg daily of prednisone or equivalent) or other immunosuppressive medication ≤14 days before the first study treatment administration * Treatment with other investigational drugs/devices within 4 weeks prior to first study treatment administration
Where this trial is running
Duarte, California and 11 other locations
- City of Hope — Duarte, California, United States (Recruiting)
- California Cancer Associates for Research and Excellence, Inc. (cCare) — Encinitas, California, United States (Recruiting)
- Providence Medical Foundation — Fullerton, California, United States (Recruiting)
- California Cancer Associates for Research and Excellence, Inc. (cCare) — San Marcos, California, United States (Recruiting)
- Sarcoma Oncology — Santa Monica, California, United States (Recruiting)
- UCLA Hematology/Oncology — Santa Monica, California, United States (Recruiting)
- Orlando Health, Inc. — Orlando, Florida, United States (Recruiting)
- BRCR Medical Center — Plantation, Florida, United States (Recruiting)
- Gabrail Cancer Center — Canton, Ohio, United States (Recruiting)
- Texas Oncology - Tyler — Tyler, Texas, United States (Recruiting)
- Virginia Cancer Specialists — Fairfax, Virginia, United States (Recruiting)
- Pan American Center for Oncology Trials (PanOncology Trials) — Rio Piedras, Puerto Rico (Recruiting)
Study contacts
- Principal investigator: Ravi Salgia, MD — City of Hope Comprehensive Cancer Center
- Study coordinator: John Ning, MD,PhD,FAIC
- Email: jning@huyabio.com
- Phone: 858-280-1866
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.