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.
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
The study team can explain what participation involves.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Sep 24, 2025 · Source: ClinicalTrials.gov
The study is underway but is not accepting new participants.
Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1
- Sponsor
- HUYABIO International, LLC.
- Interventions being studied
- Drug: HBI-2376
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- Key
- 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
- 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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- City of HopeDuarte, California
- California Cancer Associates for Research and Excellence, Inc. (cCare)Encinitas, California
- Providence Medical FoundationFullerton, California
- California Cancer Associates for Research and Excellence, Inc. (cCare)San Marcos, California
- Sarcoma OncologySanta Monica, California
- UCLA Hematology/OncologySanta Monica, California
- Orlando Health, Inc.Orlando, Florida
- BRCR Medical CenterPlantation, Florida
- Gabrail Cancer CenterCanton, Ohio
- Texas Oncology - TylerTyler, Texas
- Virginia Cancer SpecialistsFairfax, Virginia
- Pan American Center for Oncology Trials (PanOncology Trials)Rio Piedras, Puerto Rico
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Sep 24, 2025. Always confirm current availability with the study team.