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NCT04045496 · ClinicalTrials.gov registry record · Phase 1
A First-in-Human, Phase 1 Study of JAB-3312 in Adult Patients With Advanced Solid Tumors
A Phase 1 study, sponsored by Jacobio Pharmaceuticals Co..
- Completed
- Registry status
- Phase 1
- Development phase
- 40
- Enrollment target
NCT04045496: Completed Phase 1 study, sponsored by Jacobio Pharmaceuticals Co..
NCT04045496 is a Phase 1 study that has completed, run by Jacobio Pharmaceuticals Co.. The registered enrollment target is 40 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04045496, a Phase 1 study, has completed, sponsored by Jacobio Pharmaceuticals Co..
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 40 participants
- Enrollment target
Study Summary
This is a Phase 1, first-in-human, open-label dose-escalation study to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) and assess the DLT of JAB-3312. It is anticipated that approximately 24 subjects will be enrolled in the dose-escalation phase of the study. JAB-3312 will be administered orally once daily (QD) in 21-day treatment cycles.
Primary Outcome
Incidence of dose limiting toxicities (DLTs) in the dose escalation phase. A DLT is defined as an adverse event or abnormal laboratory value assessed as unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the first treatment cycle with JAB-3312.
Interventions
- DRUG JAB-3312
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2019-09-26 |
| Est. Completion | 2022-12-16 |
| Phase | Phase 1 |
What the finished NCT04045496 record still lists
NCT04045496 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% lower).
The record links to 0 conditions, and to 1 intervention - of which JAB-3312 is the first listed.
NCT04045496 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04045496 about?
NCT04045496 is a clinical study titled "A First-in-Human, Phase 1 Study of JAB-3312 in Adult Patients With Advanced Solid Tumors". This is a Phase 1, first-in-human, open-label dose-escalation study to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) and assess the DLT of JAB-3312. It is anticipated that approximately 24 subjects will be enrolled in the dose-escalation phase of the study. JAB-33...
What is the current status of trial NCT04045496?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2019-09-26. Estimated completion is 2022-12-16.
What interventions are being tested in trial NCT04045496?
The interventions under investigation include: JAB-3312 (DRUG).
Who is sponsoring clinical trial NCT04045496?
This trial is sponsored by Jacobio Pharmaceuticals Co., which has 7 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04045496's enrollment target sits among peer trials
40 1130th of 2000 higher than 810 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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