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NCT04969835 · ClinicalTrials.gov registry record · Phase 1
A Study Evaluating the Safety, Pharmacokinetics and Early Efficacy of AVA6000 in Solid Tumours
A Phase 1 study of Breast Cancer and Urothelial Carcinoma, sponsored by Avacta Life Sciences.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 158
- Enrollment target
- 9
- Study locations
NCT04969835: Recruiting Phase 1 study of Breast Cancer and Urothelial Carcinoma, sponsored by Avacta Life Sciences.
NCT04969835 is a Phase 1 study of Breast Cancer and Urothelial Carcinoma that is actively recruiting participants, run by Avacta Life Sciences. The registered enrollment target is 158 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (94% lower). The trial reports 9 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04969835, a Phase 1 study of Breast Cancer and Urothelial Carcinoma, is actively recruiting participants, sponsored by Avacta Life Sciences.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 158 participants
- Enrollment target
- 9
- Study locations
Study Summary
This is a first-in-human (FIH), Phase 1 open-label, multicentre dose escalation study investigating AVA6000 monotherapy administered intravenously in patients with locally advanced (unresectable) or metastatic solid tumours that are likely to be FAP positive. The study consists of an initial Phase 1a dose escalation portion and a subsequent Phase 1b dose expansion portion upon completion of the dose escalation portion.
Primary Outcome
Incidence and nature of DLTs
Conditions Studied
Interventions
- DRUG AVA6000
Study Locations (9)
Other
- The Beatson West of Scotland Cancer Centre, NHS Greater Glasgow & Clyde - Glasgow
- St James's University Hospital, The Leeds Teaching Hospitals NHS Trust - Leeds
- The Royal Marsden, NHS Foundation Trust - London
- The Christie NHS Foundation Trust - Manchester
- The Freeman Hospital, Newcastle-upon-Tyne NHS Foundation Trust - Newcastle upon Tyne
- Weston Park Cancer Centre, Sheffield Teaching Hospitals NHS Foundation Trust - Sheffield
New York
- Memorial Sloan Kettering Cancer Center - New York
Texas
- University of Texas MD Anderson Cancer Center - Houston
Washington
- Fred Hutchinson Cancer Center - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 158 participants |
| Start Date | 2021-07-16 |
| Est. Completion | 2026-08-15 |
| Phase | Phase 1 |
What NCT04969835 shows while recruiting
NCT04969835 is an interventional study that assigns participants to a tested intervention. The registered 158 participants enrollment target is mid-sized for trials with a published cap, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (94% lower).
The record links to 5 conditions, with Breast Cancer appearing as the primary indexed condition, and to 1 intervention - of which AVA6000 is the first listed.
NCT04969835 lists 9 locations in 4 states (Other, New York, Texas).
Frequently Asked Questions
What is clinical trial NCT04969835 about?
NCT04969835 is a clinical study titled "A Study Evaluating the Safety, Pharmacokinetics and Early Efficacy of AVA6000 in Solid Tumours". This is a first-in-human (FIH), Phase 1 open-label, multicentre dose escalation study investigating AVA6000 monotherapy administered intravenously in patients with locally advanced (unresectable) or metastatic solid tumours that are likely to be FAP positive. The study consists of an initial Phase 1...
What is the current status of trial NCT04969835?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 158 participants. The study started on 2021-07-16. Estimated completion is 2026-08-15.
What conditions does trial NCT04969835 study?
This clinical trial studies the following conditions: Breast Cancer, Urothelial Carcinoma, Soft Tissue Sarcoma, Ovarian Carcinoma, Salivary Gland Tumor.
What interventions are being tested in trial NCT04969835?
The interventions under investigation include: AVA6000 (DRUG).
Who is sponsoring clinical trial NCT04969835?
This trial is sponsored by Avacta Life Sciences, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04969835 being conducted?
This trial has 9 study locations across New York, Texas, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04969835's enrollment target sits among peer trials
158 436th of 1224 higher than 788 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Cancer 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.
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