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NCT05781360 · ClinicalTrials.gov registry record · Phase 1
A Study to Investigate the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of SIM0237 in Adult Participants with Advanced Solid Tumors
A Phase 1 study, sponsored by Jiangsu Simcere Pharmaceutical Co..
- Terminated
- Registry status
- Phase 1
- Development phase
- 192
- Enrollment target
NCT05781360: Clinical Trial Phase 1 study, sponsored by Jiangsu Simcere Pharmaceutical Co..
NCT05781360 is a Phase 1 study that was terminated before completion, run by Jiangsu Simcere Pharmaceutical Co.. The registered enrollment target is 192 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (220% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05781360, a Phase 1 study, was terminated before completion, sponsored by Jiangsu Simcere Pharmaceutical Co..
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 192 participants
- Enrollment target
Study Summary
This is a multicenter, open-label, phase I study to evaluate the safety, efficacy, and pharmacokinetic (PK)/pharmacodynamic(PD) characteristics of SIM0237 in participants with advanced solid tumors.
Primary Outcome
DLTs will be defined using NCI CTCAE version 5.0 or ASTCT criteria for Cytokine Release Syndrome (CRS).
Interventions
- DRUG SIM0237
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 192 participants |
| Start Date | 2023-03-08 |
| Est. Completion | 2024-05-25 |
| Phase | Phase 1 |
Why NCT05781360 stopped before completion
NCT05781360 is an interventional study that assigns participants to a tested intervention. The registered 192 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (220% higher).
The record links to 0 conditions, and to 1 intervention - of which SIM0237 is the first listed.
NCT05781360 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05781360 about?
NCT05781360 is a clinical study titled "A Study to Investigate the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of SIM0237 in Adult Participants with Advanced Solid Tumors". This is a multicenter, open-label, phase I study to evaluate the safety, efficacy, and pharmacokinetic (PK)/pharmacodynamic(PD) characteristics of SIM0237 in participants with advanced solid tumors.
What is the current status of trial NCT05781360?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 192 participants. The study started on 2023-03-08. Estimated completion is 2024-05-25.
What interventions are being tested in trial NCT05781360?
The interventions under investigation include: SIM0237 (DRUG).
Who is sponsoring clinical trial NCT05781360?
This trial is sponsored by Jiangsu Simcere Pharmaceutical Co., which has 2 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05781360's enrollment target sits among peer trials
192 282nd of 2000 higher than 1,718 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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