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NCT04047862 · ClinicalTrials.gov registry record · Phase 1
Study of Ociperlimab (BGB-A1217) in Combination With Tislelizumab in Advanced Solid Tumors
A Phase 1 study, sponsored by BeiGene.
- Completed
- Registry status
- Phase 1
- Development phase
- 446
- Enrollment target
NCT04047862: Completed Phase 1 study, sponsored by BeiGene.
NCT04047862 is a Phase 1 study that has completed, run by BeiGene. The registered enrollment target is 446 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (643% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04047862, a Phase 1 study, has completed, sponsored by BeiGene.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 446 participants
- Enrollment target
Study Summary
The primary objectives of this study were: to assess the safety and tolerability, to determine the maximum tolerated dose (MTD) or maximum administered dose (MAD) and to determine the recommended Phase 2 dose (RP2D) of BGB-A1217 (known as ociperlimab) in combination with tislelizumab in participants with advanced solid tumors in phase 1. Primary objective of Phase 1b was to assess overall response rate (ORR) determined by Investigator per Response Evaluation Criteria in Solid Tumors (RECIST) version (v).1.1 for patients in each dose-expansion cohort.
Primary Outcome
An AE was defined as any unfavorable and unintended sign, symptom, or disease associated with the use of study drugs, whether considered related to study drugs or not. A serious adverse event (SAE) was any untoward medical occurrence that, at any dose, resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability, was a congenital anomaly or was considered a medically significant. Treatment-emergent adverse event (TEAE) was
Interventions
- DRUG Pemetrexed
- DRUG Tislelizumab
- DRUG Paclitaxel
- DRUG Nab paclitaxel
- DRUG Ociperlimab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 446 participants |
| Start Date | 2019-08-15 |
| Est. Completion | 2024-08-07 |
| Phase | Phase 1 |
What the finished NCT04047862 record still lists
NCT04047862 is an interventional study that assigns participants to a tested intervention. The registered 446 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 (643% higher).
The record links to 0 conditions, and to 5 interventions - of which Pemetrexed is the first listed.
NCT04047862 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04047862 about?
NCT04047862 is a clinical study titled "Study of Ociperlimab (BGB-A1217) in Combination With Tislelizumab in Advanced Solid Tumors". The primary objectives of this study were: to assess the safety and tolerability, to determine the maximum tolerated dose (MTD) or maximum administered dose (MAD) and to determine the recommended Phase 2 dose (RP2D) of BGB-A1217 (known as ociperlimab) in combination with tislelizumab in participants...
What is the current status of trial NCT04047862?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 446 participants. The study started on 2019-08-15. Estimated completion is 2024-08-07.
What interventions are being tested in trial NCT04047862?
The interventions under investigation include: Pemetrexed (DRUG), Tislelizumab (DRUG), Paclitaxel (DRUG), Nab paclitaxel (DRUG), Ociperlimab (DRUG).
Who is sponsoring clinical trial NCT04047862?
This trial is sponsored by BeiGene, which has 65 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04047862's enrollment target sits among peer trials
446 59th of 2000 higher than 1,942 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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