A Dose Escalation Study of SHP2 Inhibitor in Patients With Solid Tumors Harboring KRAS of EGFR Mutations

• Status: Not yet recruiting
• Trial end date: 2024-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: HUYABIO International, LLC.

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