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

Launched by HUYABIO INTERNATIONAL, LLC. · Dec 6, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called HBI-2376, which is designed for patients with advanced solid tumors that have specific genetic mutations known as KRAS or EGFR. The main goal of the trial is to find out the highest safe dose of this medication and to learn how the body processes it. It's currently looking for participants who have cancers such as non-small cell lung cancer, colorectal cancer, or pancreatic cancer and have previously tried standard treatments that did not work for them.

To be eligible for this trial, participants need to be at least 18 years old and have a confirmed diagnosis of a solid tumor with KRAS or EGFR mutations. They should have measurable cancer that has either returned after treatment or did not respond to standard therapies. Participants can expect to undergo assessments to ensure they meet the health criteria, and they will receive the study drug in a safe and monitored environment. It's important to know that certain health conditions, such as recent heart problems or untreated brain tumors, may prevent someone from joining the study. Overall, this trial is an opportunity for patients with specific types of cancer to access a potentially new treatment option.

Gender

ALL

Eligibility 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