Health TrialsbyHealthPanel

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

ConditionsAdvanced Malignant Solid TumorSolid Tumor Cancer
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorPilatus Biosciences Inc

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • PLT012

    Drug

    PLT012 (anti-CD36 monoclonal antibody)

Treatment groups

36 Participants
are divided into 1 treatment group
Group A: Experimental Arm: PLT012Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Frequency, type and severity of dose limiting toxicities and adverse events

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

Time frame
18 months

Secondary outcomes

1

Pharmacokinetic Properties of PLT012

Plasma concentration of PLT012 at each timepoint at different dose levels

Time frame
18 months
2

Immunogenicity of PLT012

Percentage and titer of the anti-drug antibody (ADA) at different dose levels of PLT012

Time frame
18 months
3

Preliminary efficacy of PLT012

Clinical activity as evidenced by Overall Response Rate (ORR)

Time frame
18 months
4

Preliminary efficacy of PLT012

Clinical activity as evidenced by disease control rate (DCR)

Time frame
18 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Pilatus Biosciences Inc

Lead sponsor

Source ClinicalTrials.gov
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