SHR-A1811 for Solid Tumors

Recruiting at 36 trial locations

Overseen By Sherry Zhu, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Disqualifiers: Lung diseases, Bleeding tendency, others

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

Compensation: Varies

Number of Visits: Unknown

396 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new drug called SHR-A1811 to see if it is safe and effective for patients with advanced cancers that have the HER2 gene. The drug works by targeting and attacking these specific cancer cells.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What makes the drug SHR-A1811 unique for treating solid tumors?

The drug SHR-A1811 is unique because it may involve a novel mechanism of action or combination strategy that targets specific pathways in solid tumors, potentially overcoming resistance seen with other treatments. While specific details about SHR-A1811 are not provided, similar treatments like SHP2 inhibitors have shown promise in preventing resistance to other cancer drugs, suggesting SHR-A1811 might offer a new approach for patients with solid tumors. ^{1 2 3 4 5}

Eligibility Criteria

This trial is for adults with advanced solid tumors that show HER2 expression or mutation, who have tried standard treatments without success or can't tolerate them. Participants must be in good physical condition (ECOG 0-1), have a heart's pumping ability of at least 50%, and proper kidney and liver function. Women must not be pregnant or breastfeeding.

Inclusion Criteria

Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

LVEF ≥ 50% by either ECHO or MUGA

Has adequate renal and hepatic function

Exclusion Criteria

History of clinically significant lung diseases (e.g., interstitial pneumonia, pneumonitis, pulmonary fibrosis, and severe radiation pneumonitis) or suspected to have these diseases by imaging at screening period

Known hereditary or acquired bleeding and thrombotic tendency

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive escalating doses of SHR-A1811 to evaluate safety and tolerability

12 weeks

PK Expansion

Participants are monitored for pharmacokinetics and immunogenicity of SHR-A1811

1 year

Indication Expansion

Participants are evaluated for anti-tumor efficacy using RECIST 1.1 criteria

Up to 30 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

90 days

Treatment Details

Interventions

• SHR-A1811

Trial Overview The study tests SHR-A1811, focusing on its safety, how the body processes it, if it causes any immune reactions, and whether it can shrink tumors. It's an early-phase trial where all participants receive SHR-A1811 to see how well it works against different types of solid tumors.

Participant Groups

Group I: Part 3 Indication expansion Experimental Treatment 1 Intervention

Group II: Part 2 PK expansion Experimental Treatment 1 Intervention

Group III: Part 1 Dose escalation Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Jiangsu HengRui Medicine Co., Ltd.

Lead Sponsor

Trials

663

Recruited

102,000+

Founded

1970

Headquarters

Lianyungang, China

Known For

Oncology Innovations

Top Products

Camrelizumab, Rivoceranib (Apatinib)

Atridia Pty Ltd.

Industry Sponsor

Trials

30

Recruited

1,200+

Findings from Research

In a phase I trial of SHR7390 monotherapy involving 16 patients, the maximum tolerated dose (MTD) was determined to be 0.75 mg, with 25% of patients experiencing grade ≥3 treatment-related adverse events, but no objective responses were achieved.

In a combination trial with SHR7390 and camrelizumab involving 22 patients with treatment-refractory colorectal cancer, the combination showed a manageable safety profile with 22.7% of patients achieving a partial response, indicating preliminary clinical activity regardless of tumor genetic status.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Clinical Activity of SHR7390 Monotherapy or Combined With Camrelizumab for Advanced Solid Tumor: Results From Two Phase I Trials. Wei, XL., Zhang, Y., Zhao, HY., et al.[2023]

References

1. China pubmed.ncbi.nlm.nih.gov

[Inhibitory effect of SHP-1 gene transfer on the proliferation of breast cancer cell line MDA-MB-231]. [2010]

2. China pubmed.ncbi.nlm.nih.gov

[Retrovirus-mediated SHP-1 gene expression in human breast cancer MDA-MB-231 cells]. [2009]

3. England pubmed.ncbi.nlm.nih.gov

Safety and Clinical Activity of SHR7390 Monotherapy or Combined With Camrelizumab for Advanced Solid Tumor: Results From Two Phase I Trials. [2023]

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

SHP2 Inhibition Prevents Adaptive Resistance to MEK Inhibitors in Multiple Cancer Models. [2023]

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

SHP2 Inhibition Sensitizes Diverse Oncogene-Addicted Solid Tumors to Re-treatment with Targeted Therapy. [2023]