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NCT04678921 · ClinicalTrials.gov registry record · Phase 1
Study of TJ210001 Administered in Subjects With Relapsed or Refractory Advanced Solid Tumors
A Phase 1 study, sponsored by I-Mab Biopharma US Limited.
- Completed
- Registry status
- Phase 1
- Development phase
- 16
- Enrollment target
NCT04678921 is a Phase 1 study that has completed, run by I-Mab Biopharma US Limited. The registered enrollment target is 16 participants.
The verdict
NCT04678921, a Phase 1 study, has completed, sponsored by I-Mab Biopharma US Limited.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 16 participants
- Enrollment target
Study Summary
This is an open label, multi-center, multiple dose Phase 1 study to evaluate the safety, tolerability, MTD or MAD, PK, and PD of TJ210001 in subjects with relapsed or refractory advanced solid tumors. Beginning with Dose Level 1, TJ210001 will be given every week starting on Cycle 1 Day 1 (C1D1). The criteria for dose escalation/de-escalation will be based on the Bayesian optimal interval (BOIN) design with sequentially enrolled cohorts. The BOIN design is implemented in a simple way similar to the traditional 3+3 design but is more flexible and possesses superior operating characteristics that are comparable to those of the more complex model-based designs, such as the continual reassessment method (CRM).
Interventions
- DRUG TJ210001
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2020-12-17 |
| Est. Completion | 2022-11-21 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04678921
The ClinicalTrials.gov registry entry for NCT04678921 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is I-Mab Biopharma US Limited, which has 7 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which TJ210001 is the first listed.
NCT04678921 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04678921 about?
NCT04678921 is a clinical study titled "Study of TJ210001 Administered in Subjects With Relapsed or Refractory Advanced Solid Tumors". This is an open label, multi-center, multiple dose Phase 1 study to evaluate the safety, tolerability, MTD or MAD, PK, and PD of TJ210001 in subjects with relapsed or refractory advanced solid tumors. Beginning with Dose Level 1, TJ210001 will be given every week starting on Cycle 1 Day 1 (C1D1). Th...
What is the current status of trial NCT04678921?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2020-12-17. Estimated completion is 2022-11-21.
What interventions are being tested in trial NCT04678921?
The interventions under investigation include: TJ210001 (DRUG).
Who is sponsoring clinical trial NCT04678921?
This trial is sponsored by I-Mab Biopharma US Limited, which has 7 total clinical trials registered on ClinicalTrials.gov.
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