Actively Recruiting
A Phase 1 Open-Label, Dose-Escalation Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of PLT012 in Adults With Advanced Solid Tumors
Led by Pilatus Biosciences Inc · Updated on 2026-02-18
36
Participants Needed
2
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating PLT012, an anti-CD36 monoclonal antibody, in adults with advanced solid tumors to understand safe dosage levels and its effects on cancer. This phase 1, open-label, dose-escalation study aims to find out what side effects occur at different doses, how the drug behaves in the body over time, and its impact on tumor size or cancer progression. Participants receive PLT012 through intravenous infusion every three weeks. Initially, visits to the clinic will be frequent, up to five times in the first three weeks, and then decrease to once every three weeks after 12 weeks. Treatment continues until the disease worsens or participants cannot tolerate the therapy. During the study, researchers will monitor side effects, blood levels of PLT012, and tumor responses. Assessments include safety evaluations, pharmacokinetics, immunogenicity, and preliminary efficacy over 18 months. Participants will be closely observed to understand the drug's effects and tolerability throughout the study period.
CONDITIONS
Brief Title
A First in Human Study of PLT012 in Participants With Solid Tumor Cancers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years and older who have provided written informed consent
- Histologically or cytologically confirmed advanced solid tumors (excluding primary CNS malignancies)
- At least one measurable lesion according to RECIST v1.1
- ECOG performance status of 0 to 1
- Life expectancy of at least 12 weeks
- Child-Pugh Class A score for hepatocellular carcinoma patients
- Adequate organ function based on laboratory tests
- Not pregnant or breastfeeding
You will not qualify if you...
- Insufficient washout period from previous therapies as defined by the study protocol
- Ongoing Grade 2 or higher toxicities from prior treatments (with some exceptions)
- Concurrent or recent malignancy (within 2 years) other than the study disease (with some exceptions)
- Uncontrolled HIV, hepatitis B, or acute hepatitis C infections
- Unstable, uncontrolled, or untreated central nervous system metastases
- Active or recent autoimmune disease requiring treatment within 3 years
- History of any organ transplant, including allogeneic stem-cell transplant
- Clinically significant and active cardiovascular disease
- Known active alcohol or drug abuse
- Psychiatric disorders preventing understanding of informed consent
- For hepatocellular carcinoma, ascites needing paracentesis or hepatic encephalopathy requiring treatment within past 6 months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 18 months
Participants receive PLT012 administered via intravenous infusion once every 3 weeks to evaluate safety, tolerability, pharmacokinetics, and preliminary efficacy.
Infusions every 3 weeks
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
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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