A First in Human Study of PLT012 in Participants With Solid Tumor Cancers (NCT07337525)
A Phase 1 Open-Label, Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of PLT012 in Patients With Advanced Solid Tumors
๐ฉบ Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: USC Norris Comprehensive Cancer Center โ Los Angeles, California
Age range: 18 Years
๐งช Interventions in This Study
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria โ
๐ All Participating Trial Locations (4 Sites)
- USC Norris Comprehensive Cancer Center โ Los Angeles, California
- NEXT Dallas โ Dallas, Texas
- MD Anderson Cancer Center โ Houston, Texas
- NEXT Houston โ Houston, Texas
๐ Contact the Study Coordinator
Phone: (843) 203-1031
Email: Madison.Daniels@novotech-cro.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
๐ฐ Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Advanced Malignant Solid Tumor
- Safety and Preliminary Efficacy of BNT314 in Cancer Patients With Malignant Solid Tumors โ Grand Rapids, Michigan
- An Early Phase Trial of RPTR-1-201 in Advanced Solid Tumors โ Grand Rapids, Michigan
Explore by condition: All Advanced Malignant Solid Tumor clinical trials
๐ก How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.