A First in Human Study of PLT012 in Participants With Solid Tumor Cancers
Start Date
2/13/2026
Completion Date
1/1/2028
Summary
The goal of this clinical trial is to learn about what doses of PLT012 are safe to use in adults with advanced cancers in solid tumors. It will also learn about how effective different doses of PLT012 are in treating cancer. The main questions it aims to answer are: What adverse events and toxicities (harmful side effects) are associated with different doses of PLT012? What are the blood levels of PLT012 in your body at different timepoints? What effect does PLT012 have on reducing tumor size and/or preventing the worsening of cancer? All participants will receive PLT012 and none will receive placebo (a look-alike substance that contains no drug). Participants will receive PLT012 by intravenous infusion once every 3 weeks. Treatment with PLT012 can continue until the participant's disease worsens or they cannot tolerate treatment. For the first 12 weeks, visits to the clinic will be more frequent (from 1 to 5 times over a 3-week period). After the first 12 weeks, visits will be reduced to once every 3 weeks.
Detailed Description
This study is a phase 1, open label, dose escalation and dose expansion study using an initial single participant cohort followed by a BOIN design to evaluate multiple ascending doses of PLT012.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
PLT012
Conditions
Locations
USC Norris Comprehensive Cancer Center
Los Angeles, California 90033
United States
NEXT Dallas
Dallas, Texas 75039
United States
MD Anderson Cancer Center
Houston, Texas 77030
United States
NEXT Houston
Houston, Texas 77054
United States