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PLT012 for Advanced Solid Tumor Cancers

This study is looking at a new drug called PLT012 for adults with advanced solid tumor cancers. The main goals are to find out what doses of PLT012 are safe and what side effects it might cause. Researchers also want to see how well PLT012 works to shrink tumors or stop cancer from getting worse. You might be able to join if you are at least 18 years old, have advanced solid tumors (not in the brain), and meet other health requirements. All participants will receive PLT012 through an IV every three weeks. The study plans to enroll 36 people.

Study design
This is a Phase 1, open-label study, meaning both you and the study team will know you are receiving PLT012. It will involve a small number of participants to test different doses.
What's involved
You will receive PLT012 through an intravenous (IV) infusion once every 3 weeks. The study will monitor for side effects and how the drug affects your body and tumor size.
Compensation
Not stated in the trial record.
Follow-up
The study will measure side effects and their severity for 18 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07337525

A First in Human Study of PLT012 in Participants With Solid Tumor Cancers

Recruiting
PHASE1Ages 18+InterventionalTreatment
Pilatus Biosciences Inc
~36 participants
Updated 2026-07-07 on ClinicalTrials.gov
What's tested:PLT012

At a glance

Recruiting sites
4 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Frequency, type and severity of dose limiting toxicities and adverse events
Measured over 18 months

Conditions

Advanced Malignant Solid Tumor
Solid Tumor Cancer

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NCT07337525

Where you'd take part

This study runs at 4 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • MD Anderson Cancer Center

    Houston, Texasstudy coordinator listed

    Recruiting

  • NEXT Dallas

    Dallas, Texasstudy coordinator listed

    Recruiting

  • NEXT Houston

    Houston, Texasstudy coordinator listed

    Recruiting

  • USC Norris Comprehensive Cancer Center

    Los Angeles, Californiastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Anthony El-Khoueiry, MD · PRINCIPAL_INVESTIGATOR · University of Southern California

Who to contact

Novotech Project Manager
[email protected]
+1 843 203 1031
Email the study team

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Eligibility criteria

Inclusion

Aged at least 18 years and provided written informed consent
Histologically or cytologically confirmed advanced solid tumors (except primary CNS malignancies)
Has at least one measurable lesion per RECIST v1.1
ECOG PS of 0 to 1
Life expectancy of ≥ 12 weeks
Child-Pugh score of Class A (for hepatocellular carcinoma only)
Adequate organ function as defined by protocol-specified laboratory values
Not pregnant or breastfeeding

Exclusion

Insufficient washout period from prior therapies as defined in the study protocol
Ongoing Grade 2 or higher toxicities from prior treatments (with some exceptions)
Concurrent or recent (within 2 years) malignancy other than the disease under study (with some exceptions)
Uncontrolled HIV, uncontrolled hepatitis B, or uncontrolled acute hepatitis C infections
Unstable/uncontrolled or untreated central nervous system (CNS) metastasis
Active or recent (within 3 years) autoimmune disease requiring medical treatment
Recipient of any organ transplant including allogeneic stem-cell transplant
Clinically significant and active cardiovascular disease
Known active alcohol or drug abuse
Psychiatric disorders that would prohibit the understanding of the Informed Consent Form
Ascites requiring therapeutic paracentesis or hepatic encephalopathy requiring medical interventions within the past 6 months (if hepatocellular carcinoma)

What this trial measures

  • Frequency, type and severity of dose limiting toxicities and adverse events18 months

    Frequency, type and severity of dose limiting toxicities and adverse events according to NCI CTCAE v5.0