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A First in Human Study of PLT012 in Participants With Solid Tumor Cancers
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
Who can join
Ages 18 and older · All sexes
Full 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)
About the study
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.
What is being tested
- PLT012 (drug)
Sponsor: Pilatus Biosciences Inc · Participants: 36 · Started: Feb 13, 2026
Contact the study team
- Novotech Project Manager · Phone: +1 843 203 1031
Official record on ClinicalTrials.gov — NCT07337525
Locations in the U.S.
| California | USC Norris Comprehensive Cancer Center, Los Angeles |
| Texas | NEXT Dallas, Dallas MD Anderson Cancer Center, Houston NEXT Houston, Houston |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.