Early access
Sign in
Taking people in United StatesPhase 1

Tests PLT012 in adults with advanced solid tumor cancers

Tests PLT012 to learn which doses are safe in adults with advanced cancers.

Key facts

Who runs it
Pilatus Biosciences Inc
Where
Dallas, Houston, and Los Angeles, United StatesSee the 4 sites
Trial code
Registry title
A First in Human Study of PLT012 in Participants With Solid Tumor Cancers
Status
Recruiting
Phase
Phase 1
People taking part
36 people, planned
Started
13 Feb 2026
Expected to end
Jan 2028
Type of study
Interventional
Treatments tested
  • PLT012
Record updated
7 July 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with advanced solid tumors who can get PLT012 by infusion every 3 weeks to test safe doses.

Age
18 years or older
Sex
All sexes can join
Disease stage
Advanced solid tumors confirmed by tissue or cell tests, except primary CNS cancers. At least one measurable lesion per RECIST v1.1.
Earlier treatment
Enough time must have passed since earlier therapies, as set in the study protocol.

Main reasons for not taking part

  • Primary CNS cancer, or unstable, uncontrolled or untreated CNS metastasis
  • Another cancer now or within the past 2 years (with some exceptions)
  • Uncontrolled HIV, hepatitis B or acute hepatitis C
  • Any organ transplant, including allogeneic stem-cell transplant
  • Pregnant or breastfeeding

The registry criteria, word for word

Show all 19 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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)
  • Recipient of any organ transplant including allogeneic stem-cell transplant
  • Known active alcohol or drug abuse
  • Uncontrolled HIV, uncontrolled hepatitis B, or uncontrolled acute hepatitis C infections
  • Active or recent (within 3 years) autoimmune disease requiring medical treatment
  • Clinically significant and active cardiovascular disease
  • Psychiatric disorders that would prohibit the understanding of the Informed Consent Form
  • Unstable/uncontrolled or untreated central nervous system (CNS) metastasis
  • Ascites requiring therapeutic paracentesis or hepatic encephalopathy requiring medical interventions within the past 6 months (if hepatocellular carcinoma)

Where in United States

  • NEXT DallasDallas, United StatesContact: Mofopefoluwa AkinwaleTaking people
  • MD Anderson Cancer CenterHouston, United StatesContact: Administrator, Division of Clinical ResearchTaking people
  • NEXT HoustonHouston, United StatesContact: Emma MoralesTaking people
  • USC / Norris Comprehensive Cancer CenterLos Angeles, United StatesContact: Clinical Investigations Support OfficeTaking people

About the trial

What the trial wants to find out

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:

Read full original descriptionShow less

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.

The group in the trial

  • Experimental Arm: PLT012Treatment being tested

    PLT012 administered via intravenous infusion once every 3 weeks

    Treatment: PLT012

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
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
Plain-language title
Tests PLT012 in adults with advanced solid tumor cancersGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 13 November 2026.
Record updated
7 July 2026