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NCT05389462 · ClinicalTrials.gov registry record · Phase 1
A Study of Mipasetamab Uzoptirine (ADCT-601) in Participants With Solid Tumors
A Phase 1 study, sponsored by ADC Therapeutics S.A..
- Terminated
- Registry status
- Phase 1
- Development phase
- 128
- Enrollment target
NCT05389462: Clinical Trial Phase 1 study, sponsored by ADC Therapeutics S.A..
NCT05389462 is a Phase 1 study that was terminated before completion, run by ADC Therapeutics S.A.. The registered enrollment target is 128 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (113% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05389462, a Phase 1 study, was terminated before completion, sponsored by ADC Therapeutics S.A..
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 128 participants
- Enrollment target
Study Summary
The primary objective of this study is to identify the recommended phase 2 dose (RP2D) and/or the maximum tolerated dose (MTD), and characterize the safety and tolerability of ADCT-601 monotherapy and in combination with gemcitabine.
Primary Outcome
Adverse events (AEs) and serious adverse events (SAEs) are defined as any untoward medical occurrence in participants whether or not considered related to the investigational medicinal product. Any clinically significant changes in vital signs, laboratory values, 12-lead electrocardiogram (ECG) and Eastern Cooperative Oncology Group (ECOG) performance status results will be recorded as AEs and SAEs.
Interventions
- DRUG Gemcitabine
- DRUG ADCT-601
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 128 participants |
| Start Date | 2022-07-13 |
| Est. Completion | 2025-04-17 |
| Phase | Phase 1 |
Why NCT05389462 stopped before completion
NCT05389462 is an interventional study that assigns participants to a tested intervention. The registered 128 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 (113% higher).
The record links to 0 conditions, and to 2 interventions - of which Gemcitabine is the first listed.
NCT05389462 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05389462 about?
NCT05389462 is a clinical study titled "A Study of Mipasetamab Uzoptirine (ADCT-601) in Participants With Solid Tumors". The primary objective of this study is to identify the recommended phase 2 dose (RP2D) and/or the maximum tolerated dose (MTD), and characterize the safety and tolerability of ADCT-601 monotherapy and in combination with gemcitabine.
What is the current status of trial NCT05389462?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 128 participants. The study started on 2022-07-13. Estimated completion is 2025-04-17.
What interventions are being tested in trial NCT05389462?
The interventions under investigation include: Gemcitabine (DRUG), ADCT-601 (DRUG).
Who is sponsoring clinical trial NCT05389462?
This trial is sponsored by ADC Therapeutics S.A., which has 18 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05389462's enrollment target sits among peer trials
128 452nd of 2000 higher than 1,542 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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