First-in-human use of PLT012 in adults with advanced solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a phase 1, open-label, dose-escalation trial that begins with a single-participant cohort followed by a BOIN design to test multiple ascending doses of PLT012. All participants receive PLT012 by intravenous infusion every three weeks and treatment continues until disease progression or unacceptable toxicity. The trial's main goals are to characterize dose-limiting toxicities, overall safety, and the drug's pharmacokinetics, with secondary evaluation of tumor response measured by RECIST v1.1. Clinic visits are frequent during the first 12 weeks (up to five visits per 3-week period) and decrease in frequency thereafter.

Why it matters

Who can join: the full rules

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)

Where it's running

• USC Norris Comprehensive Cancer Center
  Los Angeles, California, United States Recruiting
• NEXT Dallas
  Dallas, Texas, United States Recruiting
• MD Anderson Cancer Center
  Houston, Texas, United States Recruiting
• NEXT Houston
  Houston, Texas, United States Recruiting

Study contacts

• Principal investigator: Anthony El-Khoueiry, MD — University of Southern California
• Study coordinator: Novotech Project Manager
• Email: Madison.Daniels@novotech-cro.com
• Phone: +1 843 203 1031

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.