SHP2 Inhibitor for Solid Cancers

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

42 Participants Needed

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.

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.

What data supports the effectiveness of the drug HBI-2376 for treating 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 shown promise in preclinical models and are being tested in clinical trials for various cancers. ^{1 2 3 4 5}

Is the SHP2 inhibitor safe for humans?

SHP2 inhibitors, like SHP099, have been studied in preclinical models and are currently in clinical trials for cancer treatment. While these studies focus on their effectiveness in treating cancer, they also provide some safety data, as these inhibitors are being tested in humans. ^{1 2 4 5 6}

What makes the drug HBI-2376 unique for treating solid cancers?

HBI-2376 is unique because it targets SHP2, a protein involved in cancer cell growth and immune system evasion, making it potentially effective against cancers with SHP2 mutations. This drug works by inhibiting SHP2, which can help overcome resistance to other cancer treatments and improve immune response against tumors. ^{1 2 3 5 7}

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 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

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

Treatment Details

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.

Participant Groups

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+

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Overcoming Immune Checkpoint Therapy Resistance with SHP2 Inhibition in Cancer and Immune Cells: A Review of the Literature and Novel Combinatorial Approaches. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Strategies Targeting Protein Tyrosine Phosphatase SHP2 for Cancer Therapy. [2022]

3. Netherlands pubmed.ncbi.nlm.nih.gov

SHP2 Inhibition Benefits Epidermal Growth Factor Receptor-mutated Non-Small Cell Lung Cancer Therapy. [2021]

4. Netherlands pubmed.ncbi.nlm.nih.gov

SHP2 inhibition triggers anti-tumor immunity and synergizes with PD-1 blockade. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Synthesis and biological evaluation of 2,5-diaryl-1,3,4-oxadiazole derivatives as novel Src homology 2 domain-containing protein tyrosine phosphatase 2 (SHP2) inhibitors. [2022]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Therapeutic Suppression of FAK-AKT Signaling Overcomes Resistance to SHP2 Inhibition in Colorectal Carcinoma. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

From Pyrazolones to Azaindoles: Evolution of Active-Site SHP2 Inhibitors Based on Scaffold Hopping and Bioisosteric Replacement. [2021]