Recruiting
Phase 1

PLT012

Sponsor:

Pilatus Biosciences Inc

Code:

NCT07337525

Conditions

Advanced Malignant Solid Tumor

Solid Tumor Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

PLT012

Study Details

Brief summary:

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.

Conditions

Advanced Malignant Solid Tumor

Solid Tumor Cancer

Study ID

NCT07337525

Start date

Feb 13, 2026

Status verified date

Jul, 2026

Completion date

Jan, 2028

Anticipated

Primary completion date

Sep, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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)

Study Design

Enrollment

36 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Experimental Arm: PLT012

PLT012 administered via intravenous infusion once every 3 weeks

Interventions

PLT012

PLT012 (anti-CD36 monoclonal antibody)

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Novotech Project Manager

+1 843 203 1031Madison.Daniels@novotech-cro.com

Locations

USC Norris Comprehensive Cancer Center

Recruiting

Los Angeles, California, United States, 90033

Contacts

Clinical Investigations Support Office

323-865-0240stephanie.kim2@med.usc.edu

Principal Investigator:

Anthony El-Khoueiry

NEXT Dallas

Recruiting

Dallas, Texas, United States, 75039

Contacts

Mofopefoluwa Akinwale

972-893-8800fakinwale@nextoncology.com

MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Administrator, Division of Clinical Research

713-745-7139cacartwr@mdanderson.org

Principal Investigator:

Apostolia Tsimberidou

NEXT Houston

Recruiting

Houston, Texas, United States, 77054

Contacts

Emma Morales

832-384-7912emorales@nextoncology.com

More Information

Sponsor

Pilatus Biosciences Inc

Last update posted

Jul 7, 2026

Last verified

Jul, 2026

Keywords

  • Gastrointestinal cancer
  • Liver metastases
  • Bladder cancer
  • Liver cancer
  • Phase 1
  • Dose escalation
  • Advanced solid tumors
  • cholangiocarcinoma
  • colorectal liver metastases

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Pilatus Biosciences Inc on 2026-07-07.