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New treatment option for Advanced Malignant Solid Tumor
Official title A First in Human Study of PLT012 in Participants With Solid Tumor Cancers
ClinicalTrials.gov ID: NCT07337525
What this study is testing
What is PLT012?
PLT012 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for advanced malignant solid tumor.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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
You likely can't join 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
See the full eligibility 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
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- Dallas, Texas, United States
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; Dallas, Texas, United States; Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.