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NCT07086768 · ClinicalTrials.gov registry record · Phase 1
Dose-Escalation and Dose-Expansion Study of BSI-082 Monotherapy and Combined Therapy in Patients With Advanced or Metastatic Solid Tumors
A Phase 1 study, sponsored by Lei Zheng.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 57
- Enrollment target
NCT07086768: Recruiting Phase 1 study, sponsored by Lei Zheng.
NCT07086768 is a Phase 1 study that is actively recruiting participants, run by Lei Zheng. The registered enrollment target is 57 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07086768, a Phase 1 study, is actively recruiting participants, sponsored by Lei Zheng.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 57 participants
- Enrollment target
Study Summary
This is a study that will enroll patients with cancer who have tumors that may have spread. The patients will know what medication they are being given. There will be 2 parts to the study. For the first part of the study only one medication will be taken, and the dose changed to a higher dose over time. In the second part of the study tow medications will be taken and the dose of the medication may be changed to a higher dose.
Primary Outcome
Adverse events (AEs) as characterized by type, frequency, severity (as graded by national cancer institute common terminology criteria for adverse events, NCI CTCAE V5.0), timing, seriousness, and relationship to study treatment. •And Vital sign abnormalities and laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE V5.0) and timing.
Interventions
- DRUG BSI-082
- OTHER Trastuzumab deruxtecan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 57 participants |
| Start Date | 2026-01-26 |
| Est. Completion | 2028-08-07 |
| Phase | Phase 1 |
What NCT07086768 shows while recruiting
NCT07086768 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 57 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which BSI-082 is the first listed.
NCT07086768 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07086768 about?
NCT07086768 is a clinical study titled "Dose-Escalation and Dose-Expansion Study of BSI-082 Monotherapy and Combined Therapy in Patients With Advanced or Metastatic Solid Tumors". This is a study that will enroll patients with cancer who have tumors that may have spread. The patients will know what medication they are being given. There will be 2 parts to the study. For the first part of the study only one medication will be taken, and the dose changed to a higher dose over ...
What is the current status of trial NCT07086768?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 57 participants. The study started on 2026-01-26. Estimated completion is 2028-08-07.
What interventions are being tested in trial NCT07086768?
The interventions under investigation include: BSI-082 (DRUG), Trastuzumab deruxtecan (OTHER).
Who is sponsoring clinical trial NCT07086768?
This trial is sponsored by Lei Zheng, which has 3 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07086768's enrollment target sits among peer trials
57 901st of 2000 higher than 1,099 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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