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

Part of paid clinical trials in Dallas, Texas.

Sponsor
Pilatus Biosciences Inc
Study ID
NCT07337525
Phase
PHASE1
Status
Recruiting
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Conditions

  • Advanced Malignant Solid Tumor
  • Solid Tumor Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • PLT012 — DRUG
    PLT012 (anti-CD36 monoclonal antibody)

Study Details

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.

Key Dates

Start date
Feb 13, 2026
Status verified
Feb 2026
Primary completion
Sep 30, 2027
Completion
Jan 31, 2028

Study Design

Enrollment
36 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental Arm: PLT012
    PLT012 administered via intravenous infusion once every 3 weeks

Primary Outcome Measure

Frequency, type and severity of dose limiting toxicities and adverse events [ Time Frame: 18 months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
NEXT DallasDallasTexas75039
Mofopefoluwa Akinwale
[email protected]
972-893-8800
NEXT HoustonHoustonTexas77054
Emma Morales
[email protected]
832-384-7912

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