A First in Human Study of PLT012 in Participants With Solid Tumor Cancers (NCT07337525)
🩺 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: To join this study, participants generally need to meet the listed inclusion criteria (8 items) and avoid the listed exclusions (12 items).
Location: USC Norris Comprehensive Cancer Center — Los Angeles, California
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Insufficient washout period from prior therapies as defined in the study protocol
- Ongoing Grade 2 or higher toxicities from prior treatments (with some exceptions)
- Concurrent or recent (within 2 years) malignancy other than the disease under study (with some exceptions)
- Uncontrolled HIV, uncontrolled hepatitis B, or uncontrolled acute hepatitis C infections
- Unstable/uncontrolled or untreated central nervous system (CNS) metastasis
- Active or recent (within 3 years) autoimmune disease requiring medical treatment
- Recipient of any organ transplant including allogeneic stem-cell transplant
- Clinically significant and active cardiovascular disease
- Known active alcohol or drug abuse
- Psychiatric disorders that would prohibit the understanding of the Informed Consent Form
- Ascites requiring therapeutic paracentesis or hepatic encephalopathy requiring medical interventions within the past 6 months (if hepatocellular carcinoma)
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (4 Sites)
- USC Norris Comprehensive Cancer Center — Los Angeles, California
- NEXT Dallas — Dallas, Texas
- MD Anderson Cancer Center — Houston, Texas
- NEXT Houston — Houston, Texas
💰 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 § 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.