First-in-human use of PLT012 in adults with advanced solid tumors
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
This study will try different doses of an experimental drug called PLT012 given by IV every three weeks in adults with advanced solid tumors to find safe doses and see if it shrinks tumors.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Pilatus Biosciences Inc Industry-sponsored |
| Locations | 2 sites (Dallas, Texas and 1 other locations) |
| Trial ID | NCT07337525 on ClinicalTrials.gov |
What this trial studies
This is a phase 1, open-label, dose-escalation trial that begins with a single-participant cohort followed by a BOIN design to test multiple ascending doses of PLT012. All participants receive PLT012 by intravenous infusion every three weeks and treatment continues until disease progression or unacceptable toxicity. The trial's main goals are to characterize dose-limiting toxicities, overall safety, and the drug's pharmacokinetics, with secondary evaluation of tumor response measured by RECIST v1.1. Clinic visits are frequent during the first 12 weeks (up to five visits per 3-week period) and decrease in frequency thereafter.
Who should consider this trial
Good fit: Adults (≥18) with histologically or cytologically confirmed advanced solid tumors (excluding primary CNS malignancies), at least one measurable lesion, ECOG performance status 0–1, life expectancy ≥12 weeks, and adequate organ function are the intended candidates.
Not a fit: Patients with uncontrolled HIV or viral hepatitis, unstable or untreated CNS metastases, recent other malignancies, ongoing significant toxicities from prior therapy, or poor performance status are less likely to benefit and may be excluded.
Why it matters
Potential benefit: If successful, PLT012 could identify a tolerable dose and produce tumor shrinkage for some patients, potentially offering a new treatment option.
How similar studies have performed: This is the first-in-human trial of PLT012; while phase 1 dose-escalation trials of novel oncology agents have sometimes shown early responses, their primary purpose is to establish safety and dosing rather than definitive efficacy.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Dallas, Texas and 1 other locations
- NEXT Dallas — Dallas, Texas, United States (Recruiting)
- NEXT Houston — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Anthony El-Khoueiry, MD — University of Southern California
- Study coordinator: Novotech Project Manager
- Email: Madison.Daniels@novotech-cro.com
- Phone: +1 843 203 1031
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.