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.
This study is a phase 1, open label, dose escalation and dose expansion study using an initial single participant cohort followed by a BOIN design to evaluate multiple ascending doses of PLT012.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
36
PLT012 (anti-CD36 monoclonal antibody)
USC Norris Comprehensive Cancer Center
Los Angeles, California, United States
RECRUITINGNEXT Dallas
Dallas, Texas, United States
RECRUITINGMD Anderson Cancer Center
Houston, Texas, United States
RECRUITINGNEXT Houston
Houston, Texas, United States
RECRUITINGFrequency, type and severity of dose limiting toxicities and adverse events
Frequency, type and severity of dose limiting toxicities and adverse events according to NCI CTCAE v5.0
Time frame: 18 months
Pharmacokinetic Properties of PLT012
Plasma concentration of PLT012 at each timepoint at different dose levels
Time frame: 18 months
Immunogenicity of PLT012
Percentage and titer of the anti-drug antibody (ADA) at different dose levels of PLT012
Time frame: 18 months
Preliminary efficacy of PLT012
Clinical activity as evidenced by Overall Response Rate (ORR)
Time frame: 18 months
Preliminary efficacy of PLT012
Clinical activity as evidenced by disease control rate (DCR)
Time frame: 18 months
Preliminary efficacy of PLT012
Clinical activity as evidenced by time to response (TTR)
Time frame: 18 months
Preliminary efficacy of PLT012
Clinical activity as evidenced by duration of response (DOR)
Time frame: 18 months
Preliminary efficacy of PLT012
Clinical activity as evidenced by progression-free survival (PFS)
Time frame: 18 months
Preliminary efficacy of PLT012
Clinical activity as evidenced by overall survival (OS)
Time frame: 18 months
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