SHR-A1904 for Advanced Cancer

Recruiting at 27 trial locations

Overseen By Andrea Vondraskova

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Must not be taking: CYP3A4 inhibitors, CYP2D6 inducers

Disqualifiers: Brain metastases, Cardiac insufficiency, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 21 days for the first cycle, with potential continuation up to 12 months

83 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new drug called SHR-A1904 to see if it is safe and effective for people with advanced solid tumors. The study will determine the best dose to use and check how the drug moves through the body. Researchers also want to know if the drug helps fight cancer without causing harmful side effects.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you must stop taking your current medications, but it does exclude those who have taken certain strong enzyme-affecting drugs recently. It's best to discuss your specific medications with the trial team.

Eligibility Criteria

Adults over 18 with advanced solid tumors, specifically gastric/GEJ or pancreatic cancer that's resistant to standard treatments. They must have a life expectancy of at least 3 months, good performance status (able to carry out daily activities), and measurable tumor lesions. Women who can bear children need a negative pregnancy test and agree to use contraception.

Inclusion Criteria

I have advanced stomach, GEJ, or pancreatic cancer that no longer responds to standard treatments.

My blood counts and organ functions are within the required ranges for the study.

My cancer tests positive for Claudin 18.2 based on specific staining levels.

Exclusion Criteria

Known to be allergic to any component of SHR-A1904 product (antibody conjugated toxin, antibody), or allergic to humanized monoclonal antibody products

I haven't taken strong medication that affects drug metabolism recently.

I have brain metastases but have been stable for over a month after treatment.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive SHR-A1904 to assess safety, tolerability, and determine the maximum tolerated dose (MTD) and/or recommended phase II dose (RP2D)

21 days for the first cycle, with potential continuation up to 12 months

Follow-up

Participants are monitored for safety, efficacy, and overall survival after treatment

12 months after the first dose of the last subject

Treatment Details

Interventions

• SHR-A1904

Trial Overview SHR-A1904 is being tested for safety, tolerability, and effectiveness in treating advanced solid tumors. The trial will determine the highest dose patients can take without serious side effects (MTD) and suggest a phase II dose while also studying how the body processes the drug.

Participant Groups

Group I: Single Arm Experimental Treatment 1 Intervention

Single Arm : SHR-A1904

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)