A Phase 1, Open-Label, Dose Escalation of HBI-2376 in Patients With Advanced Malignant Solid Tumors Harboring KRAS or EGFR Mutations

Trial ID: NCT05163028

Interventional - Phase 1 - Active, not recruiting

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.

Conditions

• Non Small Cell Lung Cancer
• Colorectal Cancer
• Pancreatic Cancer
• Solid Tumor
• Cancer
• Cancer of Pancreas
• Cancer of Colon

Interventions

• HBI-2376

Eligibility

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

Sponsor

HUYABIO International, LLC.

Source: ClinicalTrials.gov

Search more clinical trials on myTomorrows