Study of CRX100 for Advanced Solid Tumors
This study is testing a new treatment called CRX100, given alone or with pembrolizumab, for people with advanced solid tumors like triple-negative breast cancer, colorectal cancer, and osteosarcoma. CRX100 is made from your own immune cells (CIK cells) combined with another substance (CDSR). The main goals are to find out how safe CRX100 is, what side effects it might cause, and the best dose to use. Researchers will also look at how well it works. You might be able to join if you are at least 18 years old and have one of the specified advanced solid tumors. This study is currently looking for 60 participants.
- Study design
- This is an open-label, Phase 1 study, meaning both you and the study team will know which treatment you are receiving. It will involve about 60 participants and will first test CRX100 alone, then in combination with pembrolizumab.
- What's involved
- If you join, you will undergo a procedure called leukapheresis to collect your blood cells for making CRX100. You will also receive infusions of CRX100 and potentially other medications like fludarabine and cyclophosphamide.
- Compensation
- Not stated in the trial record.
- Follow-up
- The main safety and dosing information will be collected for 28 days after each dose you receive.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Study of CRX100 as Monotherapy and in Combination With Pembrolizumab in Patients With Advanced Solid Malignancies
At a glance
Conditions
Where it's being run
3 sites across 2 statesStudy leadership
- Oliver Dorigo, MD · PRINCIPAL_INVESTIGATOR · Stanford University
Who to contact
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What this trial measures
- Frequency of treatment-emergent Adverse Events and Dose Limiting Toxicities28 days following dose administration for each dosed subject.
The Primary Outcome Measure will be based on the frequency of treatment-emergent Adverse Events and Dose Limiting Toxicities during and after the administration of investigational drug in monotherapy and investigational drug with combination therapy.
- Determine the maximum tolerated dose (MTD), maximum feasible dose (MFD) or optimal biological dose (OBD) and determine recommended Phase 1b/Phase 2a dose level.28 days following dose administration for each dosed subject.
Review of safety review committee following subject treatment to review any AEs, SAEs, or DLTs