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RecruitingPhase 1

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

A Phase 1 Open-Label, Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of PLT012 in Patients With Advanced Solid Tumors

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Infusions

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Participants will receive PLT012 by intravenous infusion once every 3 weeks."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This first study of PLT012 in humans tests safe doses and whether it can shrink tumors or keep cancer from getting worse. It is for adults with advanced solid tumor cancers. Everyone gets PLT012 through a vein once every 3 weeks; no one gets a placebo, which has no drug.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be at least 18 years old and sign a form agreeing to join the study.
  • Have advanced solid tumor cancer confirmed by tissue or cell tests, but not cancer that started in the brain or spinal cord.
  • Have at least one tumor that can be measured using the study’s rules.
  • Be fully active or able to do light work, with limits only on hard physical activity.
  • Be expected to live at least 12 weeks.
  • If you have liver cancer, have liver function rated Class A on the Child-Pugh scale.
  • Have organs working well enough based on the study’s blood test rules.
  • Not be pregnant or breastfeeding.

Who can't join

  • Not enough time has passed since earlier treatment, or you still have moderate or worse side effects from it, with some exceptions.
  • Have another cancer now or had one within the past 2 years, with some exceptions.
  • Have uncontrolled HIV, hepatitis B, or acute hepatitis C infections.
  • Have cancer that spread to the brain or spinal cord and is untreated, unstable, or not controlled.
  • Have a disease in which the immune system attacks the body that needs treatment now or needed it within the past 3 years; or have had an organ or donor stem-cell transplant.
  • Have serious, active heart or blood vessel disease.
  • Have current alcohol or drug abuse, or a mental health condition that prevents you from understanding the study consent form.
  • If you have liver cancer, have needed belly fluid drained or treatment for brain problems caused by liver disease within the past 6 months.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (4)

CA

TX