Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA
Dates
study started
estimated completion
Principal Investigator
by Jonathan Goldman, MD (ucla)

Description

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.

Official Title

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

Details

A Phase 1, Open-Label, Dose Escalation of HBI-2376 in Patients with Advanced Malignant Solid Tumors Harboring KRAS or EGFR Mutations. The primary and secondary objectives are: 1. To determine the MTD and recommended Phase 2 dose (RP2D), of HBI-2376 as an oral monotherapy for advanced solid tumors harboring KRAS or EGFR mutations 2. To characterize the PK of HBI-2376 in subjects with advanced malignant solid tumors harboring KRAS or EGFR mutations HBI-2376 is a SHP2 Inhibitor and will be dosed once daily throughout the escalation and expansion phase. Up to 42 subjects will be enrolled sequentially into the 3+3 dose escalation and monitored throughout the study for safety and tolerability. The dose escalation phase will consist of 6 cohorts, with doses ranging from 6 to 40mg. Once the MTD of RP2D is established, additional 6 subjects will be enrolled into the expansion phase at that dose level.

Keywords

Non Small Cell Lung Cancer Colorectal Cancer Pancreatic Cancer Solid Tumor Cancer Cancer of Pancreas Cancer of Colon KRAS EGFR SHP2 FIH Pancreatic Neoplasms Colonic Neoplasms HBI-2376

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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

Locations

  • UCLA Hematology/Oncology accepting new patients
    Santa Monica California 90404 United States
  • Sarcoma Oncology accepting new patients
    Santa Monica California 90403 United States
  • California Cancer Associates for Research and Excellence, Inc. (cCare) accepting new patients
    Encinitas California 92024 United States
  • Providence Medical Foundation accepting new patients
    Fullerton California 92835 United States
  • California Cancer Associates for Research and Excellence, Inc. (cCare) accepting new patients
    San Marcos California 92069 United States
  • City of Hope accepting new patients
    Duarte California 91010 United States

Lead Scientist at UC Cancer

  • Jonathan Goldman, MD (ucla)
    HS Associate Clinical Professor, Medicine. Authored (or co-authored) 86 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
HUYABIO International, LLC.
ID
NCT05163028
Phase
Phase 1 research study
Study Type
Interventional
Participants
Expecting 42 study participants
Last Updated