Open Actively Recruiting

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


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
Study Type
Phase I


Healthy Volunteers
Minimum Age
18 Years
Maximum Age

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

Contact our clinical trial navigators for opportunities that may be suitable for you
Study Stats
Protocol No.
Bladder Cancer
Brain Cancer
Breast Cancer
Cervical Cancer
Colorectal Cancer
Esophageal Cancer
Kidney Cancer
Liver Cancer
Lung Cancer
Ovarian Cancer
Pancreatic Cancer
Stomach Cancer
Joanna Gutierrez
  • TRIO-US - Fullerton
  • TRIO-US - Orlando FL
  • UCLA Santa Monica
  • UCLA Westwood
For Providers
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