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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.

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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

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

FieldValue
Enrollment Target 18 participants
Start Date 2023-12-30
Est. Completion 2025-09-19
Phase Phase 1
Suzhou Forlong Biotechnology Co.

1 total trials

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.

Similar trials for Locally Advanced/Metastatic Solid Tumors

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 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

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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Source: ClinicalTrials.gov NCT06130722, the US trial registry maintained by the National Library of Medicine. NCT06130722 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.