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NCT05759949 · ClinicalTrials.gov registry record · Phase 1
First-in-Human Study of RLY-5836 in Advanced Breast Cancer and Other Solid Tumors
A Phase 1 study of Breast Cancer and Metastatic Breast Cancer, sponsored by Relay Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 41
- Enrollment target
- 7
- Study locations
NCT05759949: Completed Phase 1 study of Breast Cancer and Metastatic Breast Cancer, sponsored by Relay Therapeutics.
NCT05759949 is a Phase 1 study of Breast Cancer and Metastatic Breast Cancer that has completed, run by Relay Therapeutics. The registered enrollment target is 41 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (99% lower). The trial reports 7 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05759949, a Phase 1 study of Breast Cancer and Metastatic Breast Cancer, has completed, sponsored by Relay Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 41 participants
- Enrollment target
- 7
- Study locations
Study Summary
This is a Phase 1, first-in-human, open-label study designed to evaluate the maximum tolerated dose (MTD), recommended phase 2 dose (RP2D), safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of RLY-5836 in advanced solid tumors in participants harboring a PIK3CA mutation in blood and/or tumor per local assessment. The study consists of 2 parts, a dose escalation (Part 1) and a dose expansion (Part 2).
Conditions Studied
Interventions
- DRUG Fulvestrant
- DRUG Palbociclib
- DRUG Abemaciclib
- DRUG Ribociclib
- DRUG RLY-5836
Study Locations (7)
Florida
- Sarah Cannon Research Institute at Florida Cancer Specialists - Orlando
Indiana
- Community Cancer Center North - Indianapolis
Massachusetts
- Massachusetts General Hospital - Boston
New Jersey
- Rutgers Cancer Institute of New Jersey - New Brunswick
New York
- Memorial Sloan Kettering Cancer Center-Main Campus - New York
Tennessee
- Tennessee Oncology, PLLC - Nashville
Utah
- Huntsman Cancer Institute, University of Utah - Salt Lake City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 41 participants |
| Start Date | 2023-03-29 |
| Est. Completion | 2025-04-11 |
| Phase | Phase 1 |
What the finished NCT05759949 record still lists
NCT05759949 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 41 participants, a relatively small participant target, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (99% lower).
The record links to 8 conditions, with Breast Cancer appearing as the primary indexed condition, and to 5 interventions - of which Fulvestrant is the first listed.
NCT05759949 lists 7 locations in 7 states (Florida, Indiana, Massachusetts).
Frequently Asked Questions
What is clinical trial NCT05759949 about?
NCT05759949 is a clinical study titled "First-in-Human Study of RLY-5836 in Advanced Breast Cancer and Other Solid Tumors". This is a Phase 1, first-in-human, open-label study designed to evaluate the maximum tolerated dose (MTD), recommended phase 2 dose (RP2D), safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of RLY-5836 in advanced solid tumors in participants harboring a P...
What is the current status of trial NCT05759949?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 41 participants. The study started on 2023-03-29. Estimated completion is 2025-04-11.
What conditions does trial NCT05759949 study?
This clinical trial studies the following conditions: Breast Cancer, Metastatic Breast Cancer, Solid Tumor, Adult, HER2-Negative Breast Cancer, Advanced Breast Cancer.
What interventions are being tested in trial NCT05759949?
The interventions under investigation include: Fulvestrant (DRUG), Palbociclib (DRUG), Abemaciclib (DRUG), Ribociclib (DRUG), RLY-5836 (DRUG).
Who is sponsoring clinical trial NCT05759949?
This trial is sponsored by Relay Therapeutics, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05759949 being conducted?
This trial has 7 study locations across Florida, Indiana, Massachusetts, New Jersey, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05759949's enrollment target sits among peer trials
41 870th of 1224 higher than 350 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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