Phase 1 Study of SIM0505 for Advanced Solid Tumors
This study is testing a new drug called SIM0505 for people with advanced solid tumors, including platinum-resistant ovarian cancer, fallopian tube cancer, and kidney cancer (renal cell carcinoma). The main goals are to find a safe dose of SIM0505 and see if it has any anti-tumor effects. Researchers will also look at how your body handles the drug. You may be able to join if you are at least 18 years old and your cancer has not responded to standard treatments or you cannot receive them. This study is currently recruiting a large number of participants, with a planned enrollment of 738 people.
- Study design
- This is an open-label, multi-center Phase 1 study, meaning both you and your doctors will know you are receiving SIM0505. The study plans to enroll 738 participants.
- What's involved
- SIM0505 will be given by injection every 21 days. The study will involve monitoring for side effects and evaluating how well the drug works over an average of 1.5 to 2 years.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be monitored for adverse events for an average of 2 years, and for objective response rate for an average of 1.5 years.
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 Phase I Study of SIM0505 in Participants With Advanced Solid Tumors
At a glance
Conditions
Where it's being run
17 sites across 14 statesWho to contact
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What this trial measures
- dose escalation: Dose-limiting toxicity (DLT)At the end of Cycle 1 (each cycle is 21 days)
- dose escalation & optimization: Adverse events (AEs)the whole dose escalation phase，an average of 2 year
- dose optimization：Objective response rate (ORR)the whole dose optimization phase，an average of 1.5 year