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NCT06130722 · ClinicalTrials.gov registry record · Phase 1
First-in-Human, Phase I, Open-label, Multicenter, Dose Escalation Clinical Study
A Phase 1 study of Locally Advanced/Metastatic Solid Tumors, sponsored by Suzhou Forlong Biotechnology Co..
- Completed
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
- 3
- Study locations
NCT06130722: Completed Phase 1 study of Locally Advanced/Metastatic Solid Tumors, sponsored by Suzhou Forlong Biotechnology Co..
NCT06130722 is a Phase 1 study of Locally Advanced/Metastatic Solid Tumors that has completed, run by Suzhou Forlong Biotechnology Co.. The registered enrollment target is 18 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower). The trial reports 3 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06130722, a Phase 1 study of Locally Advanced/Metastatic Solid Tumors, has completed, sponsored by Suzhou Forlong Biotechnology Co..
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
- 3
- Study locations
Study Summary
First-in-Human, Phase I, open-label, multicenter, dose-escalation study to evaluate the safety, tolerability, PK, pharmacodynamics, and preliminary antitumor activity of FL115 in patients with advanced solid tumors who have progressed or are intolerant to current standard-of-care therapies, including immune check-point inhibitors administered in single-agent or combination use.
Primary Outcome
The study eligible patients will receive the investigational drug FL115 on Days 1, 8, 15, and 22 of Cycle 1 for the observation of AEs/SAEs to assess dose-limiting toxicity (DLT) in first 28 days. FL115 will be administered IV QW (on Days 1, 8, 15, and 22) in Cycle 2 and beyond. All patients will be monitored in the clinic over 24-hours for the C1D1 dose for monitoring potential cytokine release syndrome (CRS). If no CRS symptoms are observed after first dose, patients will not be asked for 24-h
Conditions Studied
Interventions
- DRUG FL115
Study Locations (3)
California
- HOAG Memorial Hospital Presbyterian - Newport Beach
- Moores Cancer Center at UCSD Health - San Diego
Ohio
- Gabriel Cancer Center - Canton
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2023-12-30 |
| Est. Completion | 2025-09-19 |
| Phase | Phase 1 |
What the finished NCT06130722 record still lists
NCT06130722 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower).
The record links to 1 condition, with Locally Advanced/Metastatic Solid Tumors appearing as the primary indexed condition, and to 1 intervention - of which FL115 is the first listed.
NCT06130722 reports a single indexed study location in California, Ohio.
Frequently Asked Questions
What is clinical trial NCT06130722 about?
NCT06130722 is a clinical study titled "First-in-Human, Phase I, Open-label, Multicenter, Dose Escalation Clinical Study". First-in-Human, Phase I, open-label, multicenter, dose-escalation study to evaluate the safety, tolerability, PK, pharmacodynamics, and preliminary antitumor activity of FL115 in patients with advanced solid tumors who have progressed or are intolerant to current standard-of-care therapies, includin...
What is the current status of trial NCT06130722?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2023-12-30. Estimated completion is 2025-09-19.
What conditions does trial NCT06130722 study?
This clinical trial studies the following conditions: Locally Advanced/Metastatic Solid Tumors.
What interventions are being tested in trial NCT06130722?
The interventions under investigation include: FL115 (DRUG).
Who is sponsoring clinical trial NCT06130722?
This trial is sponsored by Suzhou Forlong Biotechnology Co., which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06130722 being conducted?
This trial has 3 study locations across California, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT06130722's enrollment target sits among peer trials
18 1720th of 2000 higher than 216 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
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