NCT07337525

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Pilatus Biosciences Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This study is a phase 1, open label, dose escalation study using an initial single participant cohort followed by a BOIN design to evaluate multiple ascending doses of PLT012.

Conditions

• Advanced Malignant Solid Tumor
• Solid Tumor Cancer

Interventions

Type	Name	Description
DRUG	PLT012	PLT012 (anti-CD36 monoclonal antibody)

Timeline

• Start date: 2026-02-13
• Primary completion: 2027-09-01
• Completion: 2028-01-01
• First posted: 2026-01-13
• Last updated: 2026-02-18

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study