36 Participants NeededMy employer runs this trial

PLT012 for Cancer

Recruiting at 1 trial location
NP
Overseen ByNovotech Project Manager
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Pilatus Biosciences Inc
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine the safe doses of a new cancer drug, PLT012, for individuals with advanced solid tumors. It will evaluate the effectiveness of various doses and potential side effects. Participants will receive PLT012 through an IV every three weeks. Suitable candidates have advanced solid tumors and at least one tumor measurable by doctors. As a Phase 1 trial, this research focuses on understanding the treatment's effects in people, offering participants the opportunity to be among the first to receive this new drug.

Is there any evidence suggesting that PLT012 is likely to be safe for humans?

A previous study found PLT012 to be safe in animals, with no harmful effects at doses up to 200 mg/kg. This suggests the treatment might also be well-tolerated in humans. The FDA has approved PLT012 for testing in humans for treating solid tumors, indicating confidence in its safety for early trials. However, as this is an early-phase trial, the main goal is to determine the safe dosage for humans. As more information emerges from these trials, researchers will gain further insights into its safety in people.12345

Why do researchers think this study treatment might be promising?

PLT012 is unique because it is administered via intravenous infusion, which allows for direct delivery into the bloodstream, potentially leading to more efficient targeting of cancer cells. Unlike many traditional chemotherapy treatments that can affect both healthy and cancerous cells, researchers are exploring whether PLT012 targets cancer cells more specifically, which could result in fewer side effects. Additionally, the once-every-three-weeks infusion schedule might offer a more convenient treatment regimen than some existing options that require more frequent dosing.

What evidence suggests that PLT012 might be an effective treatment for cancer?

Research has shown that PLT012, which participants in this trial will receive, may help treat cancers, particularly in the liver. Early studies demonstrated that PLT012 could modify the immune system to attack tumors by targeting a protein called CD36. This enables the immune system to recognize and combat the cancer. The treatment has been effective against both active and inactive tumor types. These findings suggest that PLT012 might help shrink tumors or halt their growth.25678

Who Is on the Research Team?

AE

Anthony El-Khoueiry, MD

Principal Investigator

University of Southern California

Are You a Good Fit for This Trial?

Inclusion Criteria

* Not pregnant or breastfeeding
My organ function tests are within the required healthy range.
I am 18 years or older and have signed a consent form.
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive PLT012 by intravenous infusion once every 3 weeks. Treatment continues until disease progression or intolerance.

18 months
1 to 5 visits over a 3-week period for the first 12 weeks, then once every 3 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • PLT012

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Experimental Arm: PLT012Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Pilatus Biosciences Inc

Lead Sponsor

Citations

FDA Grants Fast Track Designation to PLT012 for ...

A phase 1 trial evaluating PLT012 in HCC, among other solid tumors, is currently underway and will report safety and preliminary clinical ...

PLT012 Receives IND Clearance from FDA for Solid Tumors

“Preclinical data has shown that PLT012 can overcome this immunogenically cold environment and elicit strong anticancer effects, which we hope ...

PLT012 Receives FDA Fast Track Designation for Liver ...

PLT012 received FDA fast track status for liver cancer, with an ongoing trial evaluating safety and early activity of the CD36-targeting ...

4.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40294022/

PLT012, a Humanized CD36-Blocking Antibody, Is Effective ...

PLT012 rejuvenates antitumor immunity by targeting metabolic pathways to reprogram the immune landscape of liver cancer and liver metastasis.

FDA Fast Track Status Advances PLT012 in HCC Care

An ongoing phase 1 trial is evaluating safety, pharmacology, and early signs of antitumor activity in patients with advanced solid tumors.

Pilatus Biosciences Publishes Preclinical Data in Cancer ...

Toxicology studies in non-human primates confirmed a favorable safety profile, with no adverse effects observed at doses up to 200 mg/kg. “This ...

NCT07337525 | A First in Human Study of PLT012 ...

... 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.

PLT012, a Humanized CD36-Blocking Antibody, Is Effective ...

PLT012 rejuvenates antitumor immunity by targeting metabolic pathways to reprogram the immune landscape of liver cancer and liver metastasis, with potential to ...