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NCT06625775 · ClinicalTrials.gov registry record · Phase 1

Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors

A Phase 1 study of Metastatic Breast Cancer and Solid Tumor, Adult, sponsored by TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics).

Recruiting
Registry status
Phase 1
Development phase
392
Enrollment target
20
Study locations

NCT06625775 is a Phase 1 study of Metastatic Breast Cancer and Solid Tumor, Adult that is actively recruiting participants, run by TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics). The registered enrollment target is 392 participants, above the 202-participant average among 139 other Metastatic Breast Cancer trials with a reported enrollment target (94% higher). The trial reports 20 study locations across 12 states.

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The verdict

NCT06625775, a Phase 1 study of Metastatic Breast Cancer and Solid Tumor, Adult, is actively recruiting participants, sponsored by TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics).

RECRUITING
Registry status
Phase 1
Development phase
392 participants
Enrollment target
20
Study locations

Study Summary

First in human study to evaluate the safety, tolerability, and pharmacokinetics (PK) of BBO-10203, a PI3Kα:RAS breaker, alone and in combination with other anti-cancer agents in patients with advanced solid tumors.

Conditions Studied

Metastatic Breast Cancer Solid Tumor, Adult Metastatic Colorectal Cancer Advanced Breast Cancer HER2-positive Metastatic Breast Cancer Metastatic Lung Cancer Advanced Lung Cancer HER2 Mutation-Related Tumors KRAS Mutant Metastatic Colorectal Cancer HR-positive, HER2-negative Advanced Breast Cancer

Interventions

  • DRUG Trastuzumab
  • DRUG Fulvestrant
  • DRUG Ribociclib
  • DRUG FOLFOX
  • DRUG BBO-10203

Study Locations (20)

Texas

  • SCRI at Mary Crowley - Dallas
  • University of Texas Southwestern Medical Center - Dallas
  • The University of Texas MD Anderson Cancer Center - Houston
  • University of Texas San Antonio (UTSA) - San Antonio

California

  • University of California Los Angeles - Los Angeles
  • University of California San Diego Moores Cancer Center - San Diego
  • UCSF Helen Diller Family Comprehensive Cancer Center - San Francisco

Massachusetts

  • Massachusetts General Hospital - Boston
  • Dana-Farber Cancer Insitute - Boston

Missouri

  • St. Lukes Hospital of Kansas City - Kansas City
  • Washington University School of Medicine - St Louis

New York

  • Columbia University Irving Medical Center - New York
  • Memorial Sloan Kettering Cancer Center - New York

Florida

  • Moffitt Cancer Center - Tampa

Indiana

  • Indiana University Simon Comprehensive Cancer Center - Indianapolis

Tennessee

  • SCRI Oncology Partners - Nashville

Trial Details

FieldValue
Enrollment Target 392 participants
Start Date 2024-10-29
Est. Completion 2028-11
Phase Phase 1

Sponsor

TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics)

3 total trials

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What the Registry Record Tells You About NCT06625775

The ClinicalTrials.gov registry entry for NCT06625775 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 392 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 202-participant average among 139 other Metastatic Breast Cancer trials with a reported enrollment target (94% higher). The listed sponsor is TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics), which has 3 total studies on file at ClinicalTrials.gov.

The record links to 10 conditions, with Metastatic Breast Cancer appearing as the primary indexed condition, and to 5 interventions - of which Trastuzumab is the first listed.

NCT06625775 reports 20 study locations spanning 12 distinct geographic areas - top geographies include Texas, California, Massachusetts.

Frequently Asked Questions

What is clinical trial NCT06625775 about?

NCT06625775 is a clinical study titled "Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors". First in human study to evaluate the safety, tolerability, and pharmacokinetics (PK) of BBO-10203, a PI3Kα:RAS breaker, alone and in combination with other anti-cancer agents in patients with advanced solid tumors.

What is the current status of trial NCT06625775?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 392 participants. The study started on 2024-10-29. Estimated completion is 2028-11.

What conditions does trial NCT06625775 study?

This clinical trial studies the following conditions: Metastatic Breast Cancer, Solid Tumor, Adult, Metastatic Colorectal Cancer, Advanced Breast Cancer, HER2-positive Metastatic Breast Cancer.

What interventions are being tested in trial NCT06625775?

The interventions under investigation include: Trastuzumab (DRUG), Fulvestrant (DRUG), Ribociclib (DRUG), FOLFOX (DRUG), BBO-10203 (DRUG).

Who is sponsoring clinical trial NCT06625775?

This trial is sponsored by TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics), which has 3 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06625775 being conducted?

This trial has 20 study locations across California, Florida, Indiana, Massachusetts, Missouri. 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.