NCT07337525RecruitingPhase 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
Source: ClinicalTrials.gov · Last updated 7 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 36 (estimated)
- First submitted
- 2 Jan 2026
- Start date
- 13 Feb 2026
- Primary completion date
- Sept 2027
- Lead sponsor
- Pilatus Biosciences Inc
- NCT number
- NCT07337525
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 36
- From 13 Feb 2026 to the primary completion date, Sept 2027
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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)
- Recipient of any organ transplant including allogeneic stem-cell transplant
- Known active alcohol or drug abuse
Other illness
- Uncontrolled HIV, uncontrolled hepatitis B, or uncontrolled acute hepatitis C infections
- Active or recent (within 3 years) autoimmune disease requiring medical treatment
- Clinically significant and active cardiovascular disease
- Psychiatric disorders that would prohibit the understanding of the Informed Consent Form
Other
- Unstable/uncontrolled or untreated central nervous system (CNS) metastasis
- Ascites requiring therapeutic paracentesis or hepatic encephalopathy requiring medical interventions within the past 6 months (if hepatocellular carcinoma)
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| NEXT Dallas Coordinator of this site? Confirm its status | Dallas | United States | Recruiting |
| NEXT Houston Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
| MD Anderson Cancer Center Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
| USC / Norris Comprehensive Cancer Center Coordinator of this site? Confirm its status | Los Angeles | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.