RecruitingPhase 1NCT07337525

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

Sponsor

Pilatus Biosciences Inc

Enrollment

36 participants

Start Date

Feb 13, 2026

Study Type

INTERVENTIONAL

Conditions

Solid Tumor Cancer Advanced Malignant Solid Tumor

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This is a first-in-human study testing a new drug called PLT012 in people with advanced solid tumour cancers. It is an early-phase safety study to find out how the drug behaves in the body, what side effects it causes, and what doses are safe. **You may be eligible if...** - You are 18 or older - You have a confirmed advanced solid tumour cancer (not a primary brain cancer) - Your cancer can be measured on a scan - You are in reasonably good physical condition (ECOG score 0–1) - You have a life expectancy of at least 12 weeks - Your blood, liver, and kidney function are adequate - You are not pregnant or breastfeeding **You may NOT be eligible if...** - You still have significant side effects from your last cancer treatment - You have active uncontrolled HIV, hepatitis B, or hepatitis C - You have untreated or unstable brain metastases - You have had an active autoimmune disease requiring treatment in the last 3 years - You have had an organ or stem cell transplant - You have significant active heart disease - You had another active cancer in the last 2 years (some exceptions apply) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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