NCT07337525 A First in Human Study of PLT012 in Participants With Solid Tumor Cancers
| NCT ID | NCT07337525 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Pilatus Biosciences Inc |
| Condition | Advanced Malignant Solid Tumor |
| Study Type | INTERVENTIONAL |
| Enrollment | 36 participants |
| Start Date | 2026-02-13 |
| Primary Completion | 2027-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 36 participants in total. It began in 2026-02-13 with a primary completion date of 2027-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * Aged at least 18 years and provided written informed consent * Histologically or cytologically confirmed advanced solid tumors (except primary CNS malignancies) * Has at least one measurable lesion per RECIST v1.1 * ECOG PS of 0 to 1 * Life expectancy of ≥ 12 weeks * Child-Pugh score of Class A (for hepatocellular carcinoma only) * Adequate organ function as defined by protocol-specified laboratory values * Not pregnant or breastfeeding 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)
Contact & Investigator
Anthony El-Khoueiry, MD
PRINCIPAL INVESTIGATOR
University of Southern California
Frequently Asked Questions
Who can join the NCT07337525 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Advanced Malignant Solid Tumor. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07337525 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07337525 currently recruiting?
Yes, NCT07337525 is actively recruiting participants. Contact the research team at Madison.Daniels@novotech-cro.com for enrollment information.
Where is the NCT07337525 trial being conducted?
This trial is being conducted at Los Angeles, United States, Dallas, United States, Houston, United States, Houston, United States.
Who is sponsoring the NCT07337525 clinical trial?
NCT07337525 is sponsored by Pilatus Biosciences Inc. The principal investigator is Anthony El-Khoueiry, MD at University of Southern California. The trial plans to enroll 36 participants.