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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 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.

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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

Breast Cancer Metastatic Breast Cancer Solid Tumor, Adult HER2-Negative Breast Cancer Advanced Breast Cancer Unresectable Solid Tumor Hormone Receptor Positive Tumor PIK3CA Mutation

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

FieldValue
Enrollment Target 41 participants
Start Date 2023-03-29
Est. Completion 2025-04-11
Phase Phase 1

Sponsor

Relay Therapeutics

5 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05759949

The ClinicalTrials.gov registry entry for NCT05759949 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 41 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (99% lower). The listed sponsor is Relay Therapeutics, which has 5 total studies on file at ClinicalTrials.gov.

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 reports 7 study locations spanning 7 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.