SHP2 Inhibitor for Solid Cancers

Recruiting in Palo Alto (17 mi)

+11 other locations

Overseen byRavi Salgia, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: HUYABIO International, LLC.

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial is testing a new drug called HBI-2376 in patients with advanced solid tumors that have specific genetic changes. The drug aims to block a protein that helps cancer cells grow, potentially stopping or slowing down the cancer.

Research Team

Ravi Salgia, MD

Principal Investigator

City of Hope Comprehensive Cancer Center

Eligibility Criteria

Adults with advanced solid tumors that have specific mutations (KRAS or EGFR) and who have not responded to standard treatments can join. They must be able to take pills, have good organ function, and a performance status indicating they are relatively active. People with untreated brain metastases, recent heart issues, ongoing severe side effects from past cancer treatment, pregnancy, or autoimmune diseases cannot participate.

Inclusion Criteria

My condition did not improve, or I cannot tolerate, or I refuse standard treatments.

My cancer has KRAS or EGFR mutations.

I am 18 years or older and have agreed to participate in this study.

See 4 more

Exclusion Criteria

I have not had a stroke or heart attack in the last 6 months.

I have not taken SHP2 inhibitors before.

I have stable brain metastases and haven't needed steroids for 4 weeks.

See 6 more

Treatment Details

Interventions

HBI-2376 (Protein Tyrosine Phosphatase Inhibitor)

Trial OverviewThe trial is testing HBI-2376's safety at different doses in patients with certain genetic mutations in their tumors. It aims to find the highest dose patients can tolerate without severe side effects and will also see how the body processes the drug.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Dose Escalation and ExpansionExperimental Treatment1 Intervention

HBI-2376 will be given orally in ascending doses (escalation cohort), until the maximum tolerated dose or recommended Phase 2 dose is reached. Up to 6 patients will then be enrolled in the expansion cohort at the recommended dose.