Actively Recruiting
A First in Human Study of PLT012 in Participants With Solid Tumor Cancers
Led by Pilatus Biosciences Inc · Updated on 2026-02-18
36
Participants Needed
2
Research Sites
98 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A First in Human Study of PLT012 in Participants With Solid Tumor Cancers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged at least 18 years and provided written informed consent
- Confirmed advanced solid tumors (excluding primary CNS malignancies)
- At least one measurable lesion per RECIST v1.1
- ECOG performance status of 0 to 1
- Life expectancy of 12 weeks or more
- Child-Pugh Class A for hepatocellular carcinoma patients
- Adequate organ function as per lab tests
- Not pregnant or breastfeeding
You will not qualify if you...
- Insufficient time since prior therapies as defined in the protocol
- Ongoing Grade 2 or higher toxicities from previous treatments (with some exceptions)
- Other recent or concurrent malignancies within 2 years (with some exceptions)
- Uncontrolled HIV, hepatitis B, or acute hepatitis C infections
- Unstable, untreated, or uncontrolled central nervous system metastases
- Active or recent autoimmune diseases requiring treatment within 3 years
- History of any organ or allogeneic stem-cell transplant
- Significant active cardiovascular disease
- Known active alcohol or drug abuse
- Psychiatric disorders preventing understanding of informed consent
- Recent ascites requiring paracentesis or hepatic encephalopathy needing treatment within 6 months (for hepatocellular carcinoma)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
NEXT Dallas
Dallas, Texas, United States, 75039
Actively Recruiting
2
NEXT Houston
Houston, Texas, United States, 77054
Actively Recruiting
Research Team
N
Novotech Project Manager
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here