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NCT04257110 · ClinicalTrials.gov registry record · Phase 1
A First-in-human Study of Multiple Doses of BB-1701 in Subjects With Locally Advanced/Metastatic HER2 Expressing Solid Tumors
A Phase 1 study of Locally Advanced/Metastatic HER2 Positive Solid Tumors, sponsored by Bliss Biopharmaceutical (Hangzhou) Co..
- Completed
- Registry status
- Phase 1
- Development phase
- 117
- Enrollment target
- 12
- Study locations
NCT04257110: Completed Phase 1 study of Locally Advanced/Metastatic HER2 Positive Solid Tumors, sponsored by Bliss Biopharmaceutical (Hangzhou) Co..
NCT04257110 is a Phase 1 study of Locally Advanced/Metastatic HER2 Positive Solid Tumors that has completed, run by Bliss Biopharmaceutical (Hangzhou) Co.. The registered enrollment target is 117 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (95% higher). The trial reports 12 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04257110, a Phase 1 study of Locally Advanced/Metastatic HER2 Positive Solid Tumors, has completed, sponsored by Bliss Biopharmaceutical (Hangzhou) Co..
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 117 participants
- Enrollment target
- 12
- Study locations
Study Summary
This is an open-label, first-in-human (FIH), phase 1 dose-escalation and cohort expansion study of BB-1701 in subjects with locally advanced/metastatic HER2 expressing solid tumors. The study consists of 2 parts: dose-escalation (Part 1) and cohort expansion (Part 2). Part 1 consists of dose escalation cohorts for determining the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D). Part 2 consists of expansion cohorts, including but not limited to breast cancer, gastric/gastroesophageal junction cancer, bladder cancer and colon cancer, for exploring 1 or more RP2Ds or schedules for expanding/deepening the information/knowledge about clinical safety, clinical pharmacokinetics and anti-tumor activity.
Primary Outcome
To evaluate the safety and tolerability of BB-1701
Conditions Studied
Interventions
- DRUG BB-1701
Study Locations (12)
Other
- Cancer Hospital Chinese Academy of Medical Science - Beijing
- Sun Yat-sen Memorial Hospital - Guangzhou
- The First Affiliated Hospital of Zhejiang University - Hangzhou
- Sir Run Run Shaw Hospital - Zhejiang University School of Medicine - Hangzhou
- Zhejiang Cancer Hospital - Hanzhou
- Linyi Cancer Hospital - Linyi
- Hubei Cancer Hospital - Wuhan
California
- UCSF Helen Diller Family Comprehensive Cancer Center - San Francisco
Tennessee
- Sarah Cannon Research - Nashville
Virginia
- The Regents of NEXT Virginia, LLC - Fairfax
Jiangsu
- Jiangsu Province Hospital - Nanjin
Tianjin Municipality
- Tianjin Medical University Cancer Institute and Hospital - Tianjin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 117 participants |
| Start Date | 2020-07-28 |
| Est. Completion | 2024-12-31 |
| Phase | Phase 1 |
What the finished NCT04257110 record still lists
NCT04257110 is an interventional study that assigns participants to a tested intervention. The registered 117 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 (95% higher).
The record links to 1 condition, with Locally Advanced/Metastatic HER2 Positive Solid Tumors appearing as the primary indexed condition, and to 1 intervention - of which BB-1701 is the first listed.
NCT04257110 lists 12 locations in 6 states (Other, California, Tennessee).
Frequently Asked Questions
What is clinical trial NCT04257110 about?
NCT04257110 is a clinical study titled "A First-in-human Study of Multiple Doses of BB-1701 in Subjects With Locally Advanced/Metastatic HER2 Expressing Solid Tumors". This is an open-label, first-in-human (FIH), phase 1 dose-escalation and cohort expansion study of BB-1701 in subjects with locally advanced/metastatic HER2 expressing solid tumors. The study consists of 2 parts: dose-escalation (Part 1) and cohort expansion (Part 2). Part 1 consists of dose escalat...
What is the current status of trial NCT04257110?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 117 participants. The study started on 2020-07-28. Estimated completion is 2024-12-31.
What conditions does trial NCT04257110 study?
This clinical trial studies the following conditions: Locally Advanced/Metastatic HER2 Positive Solid Tumors.
What interventions are being tested in trial NCT04257110?
The interventions under investigation include: BB-1701 (DRUG).
Who is sponsoring clinical trial NCT04257110?
This trial is sponsored by Bliss Biopharmaceutical (Hangzhou) Co., which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04257110 being conducted?
This trial has 12 study locations across California, Tennessee, Virginia, Jiangsu, Tianjin Municipality. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04257110's enrollment target sits among peer trials
117 499th of 2000 higher than 1,500 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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