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NCT07337525 · ClinicalTrials.gov registry record · Phase 1
A First in Human Study of PLT012 in Participants With Solid Tumor Cancers
A Phase 1 study of Solid Tumor Cancer and Advanced Malignant Solid Tumor, sponsored by Pilatus Biosciences.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 36
- Enrollment target
- 2
- Study locations
NCT07337525: Recruiting Phase 1 study of Solid Tumor Cancer and Advanced Malignant Solid Tumor, sponsored by Pilatus Biosciences.
NCT07337525 is a Phase 1 study of Solid Tumor Cancer and Advanced Malignant Solid Tumor that is actively recruiting participants, run by Pilatus Biosciences. The registered enrollment target is 36 participants, below the 853-participant average among 10 other Solid Tumor Cancer trials with a reported enrollment target (96% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07337525, a Phase 1 study of Solid Tumor Cancer and Advanced Malignant Solid Tumor, is actively recruiting participants, sponsored by Pilatus Biosciences.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 36 participants
- Enrollment target
- 2
- Study locations
Study 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.
Primary Outcome
Frequency, type and severity of dose limiting toxicities and adverse events according to NCI CTCAE v5.0
Conditions Studied
Interventions
- DRUG PLT012
Study Locations (2)
Texas
- NEXT Dallas - Dallas
- NEXT Houston - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2026-02-13 |
| Est. Completion | 2028-01 |
| Phase | Phase 1 |
What NCT07337525 shows while recruiting
NCT07337525 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 853-participant average among 10 other Solid Tumor Cancer trials with a reported enrollment target (96% lower).
The record links to 2 conditions, with Solid Tumor Cancer appearing as the primary indexed condition, and to 1 intervention - of which PLT012 is the first listed.
NCT07337525 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT07337525 about?
NCT07337525 is a clinical study titled "A First in Human Study of PLT012 in Participants With Solid Tumor Cancers". 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 toxiciti...
What is the current status of trial NCT07337525?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 2026-02-13. Estimated completion is 2028-01.
What conditions does trial NCT07337525 study?
This clinical trial studies the following conditions: Solid Tumor Cancer, Advanced Malignant Solid Tumor.
What interventions are being tested in trial NCT07337525?
The interventions under investigation include: PLT012 (DRUG).
Who is sponsoring clinical trial NCT07337525?
This trial is sponsored by Pilatus Biosciences, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07337525 being conducted?
This trial has 2 study locations across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Solid Tumor Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT07337525's enrollment target sits among peer trials
36 9th of 10 higher than 2 of 10 other Solid Tumor Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Solid Tumor Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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