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

About

Brief 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.

Primary Purpose
Treatment
Study Type
Interventional
Phase
Phase I

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
N/A

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

Join this Trial

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Study Stats
Protocol No.
21-002025
Category
Hematology-Oncology
Oncology
Contact
CINDY TONG
Location
  • UCLA Santa Monica
  • UCLA Westwood
For Providers
NCT No.
NCT05163028
For detailed technical eligibility, visit ClinicalTrials.gov.