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

NCT07337525 | Recruiting Phase 1 FDA Drug

• 1 other identifier: PLT012-P1-001
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 2

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

Keywords

Gastrointestinal cancer; Liver metastases; Bladder cancer; Liver cancer; Phase 1; Dose escalation; Advanced solid tumors

Outcome Measures

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

  18 months

Secondary Outcomes (8)

• Pharmacokinetic Properties of PLT012

  18 months

• Immunogenicity of PLT012

  18 months

• Preliminary efficacy of PLT012

  18 months

• Preliminary efficacy of PLT012

  18 months

• Preliminary efficacy of PLT012

  18 months

Study Arms (1)

Experimental Arm: PLT012

EXPERIMENTAL

PLT012 administered via intravenous infusion once every 3 weeks

Drug: PLT012

Interventions

PLT012 DRUG

PLT012 (anti-CD36 monoclonal antibody)

Experimental Arm: PLT012

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Pilatus Biosciences Inc: lead

Study Sites (2)

NEXT Dallas

Dallas, Texas, 75039, United States

RECRUITING

NEXT Houston

Houston, Texas, 77054, United States

RECRUITING

MeSH Terms

Conditions

Gastrointestinal Neoplasms; Urinary Bladder Neoplasms; Liver Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Urologic Neoplasms; Urogenital Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Liver Diseases

Study Officials

• Anthony El-Khoueiry, MD

  University of Southern California

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Novotech Project Manager

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2026
• First Posted: January 13, 2026
• Study Start: February 13, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: February 18, 2026

Record last verified: 2026-02

Locations

US (2)