SHP2 Inhibitor for Solid Cancers

Not currently recruiting at 11 trial locations

Overseen By Sant P Chawla, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: HUYABIO International, LLC.

Must not be taking: Steroids, Immunosuppressants

Disqualifiers: Concurrent malignancy, CNS metastases, Cardiovascular disease, Autoimmune diseases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new drug, HBI-2376, a SHP2 inhibitor, to determine the right dose for patients with solid tumors that have specific mutations called KRAS or EGFR. Researchers aim to observe how the drug behaves in the body and identify any side effects. This study targets individuals whose cancer treatments have failed or who cannot undergo standard treatments. Eligible participants should have advanced cancer with these mutations and be able to swallow pills. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you cannot have taken other investigational drugs or certain immunosuppressive medications within 4 weeks before starting the study.

Is there any evidence suggesting that HBI-2376 is likely to be safe for humans?

Research has shown that HBI-2376 is a new drug designed to treat solid tumors with specific genetic changes. Early lab studies found that this drug is generally safe and well-absorbed when taken by mouth, indicating safety in animal tests.

Human trials are in the early stages, focusing on finding the right dose. The current study aims to determine the safest dose for people by gradually increasing the amount given to patients. As a Phase 1 trial, the main goal is to ensure safety and understand how the drug works in the body.

While detailed safety information for humans isn't available yet, the trial's initiation suggests that early tests were promising enough to proceed. Participants are closely monitored for any side effects to ensure their well-being. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for solid cancers, which often involve chemotherapy or immunotherapy, HBI-2376 targets a specific protein called SHP2, which plays a crucial role in cancer cell growth. This unique mechanism of action allows it to potentially inhibit cancer progression more effectively by directly interfering with a key signal pathway that cancer cells rely on. Researchers are excited about HBI-2376 because targeting SHP2 could offer a more precise and possibly less toxic alternative to traditional cancer therapies, focusing on the cancer's specific vulnerabilities.

What evidence suggests that HBI-2376 might be an effective treatment for solid cancers?

Research shows that SHP2 inhibitors, such as HBI-2376, can halt cancer cell growth and aid the immune system in combating tumors. Studies have demonstrated that SHP2 inhibitors effectively treat cancers with KRAS or EGFR mutations, common in many solid tumors. Early findings suggest these inhibitors can increase cancer cells' responsiveness to treatment, potentially improving patient outcomes. Initial data indicates that HBI-2376, the investigational treatment in this trial, is generally well-tolerated and may benefit patients with advanced cancers. ^{1 3 6 7 8}

Who Is on the Research Team?

Ravi Salgia, MD

Principal Investigator

City of Hope Comprehensive Cancer Center

Are You a Good Fit for This Trial?

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 fully active or can carry out light work.

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive HBI-2376 in ascending doses to determine the maximum tolerated dose

Up to 36 months

Regular visits for dose escalation monitoring

Expansion

Additional participants receive HBI-2376 at the recommended Phase 2 dose

Up to 36 months

Regular visits for safety and efficacy monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• HBI-2376

Trial Overview The 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.

How Is the Trial Designed?

Group I: Dose Escalation and Expansion Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

HUYABIO International, LLC.

Lead Sponsor

Trials

12

Recruited

960+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05163028

NCT05163028 | A Dose Escalation Study of SHP2 Inhibitor ... 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 ...

2. jacobiopharma.com jacobiopharma.com/en/pipeline/shp2

SHP2 Inhibitor | Jacobio Pharma 1.2million patients benefited ... Estimates from the global tumor incidence data from 2019 indicate that 1.2 million patients with advanced solid tumors worldwide ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10401072/

SHP2 Inhibition Sensitizes Diverse Oncogene-Addicted ... This phase I trial with an alternative and biologically informed dose-escalation design demonstrated targeted therapy resensitization with SHP2 inhibitor ...

4. withpower.com withpower.com/trial/phase-1-pancreatic-neoplasms-11-2021-4bc93

SHP2 Inhibitor for Solid Cancers Research shows that SHP2 inhibitors, like HBI-2376, can help stop cancer cell growth and boost the body's immune response against tumors. These inhibitors have ...

5. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.e15140

Initial results from a phase I study of the SHP2 inhibitor ... GH21 was generally well tolerated while providing benefits to heavily treated NSCLC, HNSCC and EC, who has a favorable pharmacokinetic property as monotherapy.

6. aacrjournals.org aacrjournals.org/mct/article/22/12_Supplement/A098/730702/Abstract-A098-HBI-2376-HUYABIO-clinical-stage-SHP2

Abstract A098: HBI-2376, HUYABIO clinical stage SHP2 ... HBI-2376 is an orally bioavailable selective SHP2 inhibitor developed for the treatment of solid tumors harboring KRAS or EGFR mutations.

7. delta.larvol.com delta.larvol.com/Products/?ProductId=2c1e3e8f-9143-4ace-9cf0-43d791fac064

HBI-2376 / HUYA Bioscience, Genhouse Bio HBI-2376-101: A Dose Escalation Study of SHP2 Inhibitor in Patients With Solid Tumors Harboring KRAS of EGFR Mutations (clinicaltrials.gov) - P1 | N=42 ...

8. genhousebio.com genhousebio.com/en/html/news/110.html

Preclinical data of Genhouse's SHP2 inhibitor presented at ... At the same time, GH21 shows good safety profile and high oral bioavailability. It is expected to bring new treatment options for solid tumor ...