SHR-A1904 for Advanced Cancer

Recruiting in Palo Alto (17 mi)

+27 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Recruiting

Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Must not be taking: CYP3A4 inhibitors, CYP2D6 inducers

Disqualifiers: Brain metastases, Cardiac insufficiency, others

No Placebo Group

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.

+6 more

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.

+12 more

Trial 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

Participant Groups

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.

1Treatment groups

Experimental Treatment

Group I: Single ArmExperimental Treatment1 Intervention

Single Arm : SHR-A1904