SHR-A1904 for Advanced Solid Tumors
This study is testing a drug called SHR-A1904 in people with advanced solid tumors, including gastric (stomach) and gastroesophageal junction (where the esophagus meets the stomach) cancer, or pancreatic cancer. The main goals are to understand how safe SHR-A1904 is, what side effects it might cause, and to find the highest dose that can be given safely. Researchers will also look at how the body handles the drug and if it shows any early signs of effectiveness. You may be able to join if you are over 18, have advanced solid tumors that have returned or not responded to previous treatments, and have a good general health status. The study aims to enroll 83 participants, but its current recruitment status is unclear.
- Study design
- This is a single-arm study, meaning all participants will receive SHR-A1904. It is a dose-escalation and dose-expansion study, which means different groups of participants will receive increasing doses of the drug to find the safest and most effective amount.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoints, which measure safety and dose, are assessed during the first cycle of administration, up to 21 days.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
A TRIAL TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND EFFICACY OF SHR-A1904 IN SUBJECTS WITH ADVANCED SOLID TUMORS
At a glance
Conditions
Where it's being run
28 sites across 12 statesWho to contact
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What this trial measures
- Dose-limiting toxicity (DLT)The first cycle of administration, up to 21 days.
DLT is defined during the first cycle of the study treatment and assessed as certainly or at least possibly related to SHR-A1904 treatment.
- Maximum tolerated dose (MTD)The first cycle of administration, up to 21 days.
MTD is defined as the dose with the estimated toxicity probability which is the closest to the target toxicity probability.
- Recommended Phase 2 Dose (RP2D)The first cycle of administration, up to 21 days.
RP2D is the dose selected for further study based on the phase I study results.
- Adverse events (AEs) and serious adverse events (SAEs)From the signing of informed consent form to the end of safety follow-up period (90 days after the last dose).