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Solid Tumor, AdultPhase 1NCT06625775

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

A Phase 1 study testing BBO-10203, Trastuzumab and Fulvestrant in people with Solid Tumor, Adult and Metastatic Breast Cancer, run by TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics) at 44 sites in 6 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
BBO-10203, Trastuzumab and Fulvestrant
Could I receive a placebo?
No, everyone receives an active treatment
How many people
392 participants
Where
44 sitesin 6 countries
Study dates
29 Oct 2024to Nov 2028
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Locally advanced and unresectable or metastatic HER2-positive advanced breast cancer (aBC), HR-positive/HER2-negative advanced breast cancer, KRAS mutant advanced colorectal cancer (aCRC), or KRAS mutant advanced non-small cell lung cancer (aNSCLC)
  • Measurable disease by RECIST v1.1 (except for HR-positive HER2-negative aBC where evaluable bone-only disease is permitted)
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1
  • Adequate LVEF assessed by ECHO or MUGA (BBO-10203 + Trastuzumab cohorts only)
  • Stable brain metastases
  • Patients with HER2-positive aBC: Must have had at least 2 prior lines of anti-HER2-directed therapy. Only 1 prior line is acceptable where there is no other regionally available standard of care (SoC)
Show all 10Show fewer
  • Monotherapy Cohort patients with HR-positive, HER2-negative aBC, KRAS mutant aCRC or aNSCLC: Must have progression on, or disease recurrence after at least one line of SOC treatment or in the opinion of the investigator, would be unlikely to tolerate or derive clinically meaningful benefit from SoC therapy
  • BBO-10203 + Fulvestrant combination cohort patients with HR-positive, HER2-negative aBC: confirmed PIK3CA mutation, must have been treated with a CDK4/6i
  • BBO-10203 + Fulvestrant + ribociclib combination cohort patients with HR-positive, HER2-negative aBC: confirmed PIK3CA mutation, no prior systemic therapy in the aBC setting permitted
  • BBO-10203 + FOLFOX + Bevacizumab combination cohort patients with KRAS mutant aCRC: One prior line of irinotecan-containing therapy for locally advanced or metastatic CRC is allowed but not required

Who cannot join

  • Patients with KRAS mutant aCRC who have KRAS G12R mutation, BRAFV600E mutation, HER2amp, or dMMR/MSI-H tumors
  • Patients with KRAS mutant aNSCLC who have KRAS G12R mutation, or tumors with other targetable driver mutations (eg, EGFR, anaplastic lymphoma kinase, ROS1/BRAF/RET/MET/EGFR exon20 insertion/NTRK/HER2)
  • Patients with untreated and/or non-stable brain metastases
  • Other inclusion/exclusion criteria are specified in the protocol

Trial locations and contacts

44 sites in 6 countries. Contact the study team or a site near you to ask about taking part.

BBOT (BridgeBio Oncology Therapeutics) contact

650-405-8440

Breaker-101ct.gov@bridgebiooncology.com

44 sites in 6 countries

United States19 sites, 18 recruiting

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

    Recruiting

  • Dana-Farber Cancer Insitute

    Boston, Massachusetts, 02215

    Recruiting

  • SCRI at Mary Crowley

    Dallas, Texas, 75230

    Recruiting

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390

    Recruiting

  • City of Hope Comprehensive Cancer Center

    Duarte, California, 91010

    Recruiting

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

    Recruiting

  • Indiana University Simon Comprehensive Cancer Center

    Indianapolis, Indiana, 46202

    Recruiting

  • St. Lukes Hospital of Kansas City

    Kansas City, Missouri, 64111

    Recruiting

  • University of California Los Angeles

    Los Angeles, California, 90095

    Recruiting

  • Wisconsin Institute for Medical Research

    Madison, Wisconsin, 53792

    Recruiting

  • SCRI Oncology Partners

    Nashville, Tennessee, 37203

    Recruiting

  • Columbia University Irving Medical Center

    New York, New York, 10032

    Recruiting

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

    Recruiting

  • University of Texas San Antonio (UTSA)

    San Antonio, Texas, 78229

    Recruiting

  • University of California San Diego Moores Cancer Center

    San Diego, California, 92093

    Recruiting

  • UCSF Helen Diller Family Comprehensive Cancer Center

    San Francisco, California, 94158

    Withdrawn

  • Fred Hutchinson Cancer Center

    Seattle, Washington, 98109

    Recruiting

  • Washington University School of Medicine

    St Louis, Missouri, 63110

    Recruiting

  • Moffitt Cancer Center

    Tampa, Florida, 33612

    Recruiting

Other trials in United States

Spain9 sites, 9 recruiting

  • Hospital Universitario Vall d'Hebron

    Barcelona, Catalonia, 08035

    Recruiting

  • IOB Institute of Oncology - Hospital Quironsalud Barcelona

    Barcelona, 08023

    Recruiting

  • START Barcelona - HM Nou Delfos Hospital

    Barcelona, 08023

    Recruiting

  • Hospital Universitari Arnau de Vilanova

    Lleida, 25198

    Recruiting

  • Hospital Beata Maria Ana

    Madrid, Madrid, 28007

    Recruiting

  • Hospital Universitario Fundación Jiménez Díaz

    Madrid, 28040

    Recruiting

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

    Recruiting

  • Hospital Quiron Madrid - NEXT Oncology

    Pozuelo de Alarcón, Madrid, 28223

    Recruiting

  • Hospital Universitari i Politècnic La Fe

    Valencia, 46026

    Recruiting

Other trials in Spain

Brazil6 sites, 6 recruiting

  • Liga Contra o Câncer

    Natal, Rio Grande do Norte, 59062

    Recruiting

  • FUTTURA Oncologia

    Porto Alegre, Rio Grande do Sul, 90470

    Recruiting

  • Hospital São Lucas da PUCRS

    Porto Alegre, Rio Grande do Sul, 90610

    Recruiting

  • Instituto do Câncer do Estado de São Paulo - ICESP

    São Paulo, São Paulo, 01246

    Recruiting

  • Clinica de Pesquisas e Centro de Estudos Em Oncologia Ginecologica e Mamaria Ltda

    São Paulo, São Paulo, 01317

    Recruiting

  • IEPE - Unimed Sorocaba

    Sorocaba, São Paulo, 18056

    Recruiting

Other trials in Brazil

France6 sites, 6 recruiting

  • Institut Bergonie

    Bordeaux, 33000

    Recruiting

  • Centre Léon Bérard

    Lyon, 69008

    Recruiting

  • Institut régional du Cancer de Montpellier - Val d'Aurelle

    Montpellier, Occitanie, 34298

    Recruiting

  • Institut Curie - René-Huguenin Hospital

    Saint-Cloud, Paris, 92210

    Recruiting

  • lnstitut de Cancérologie de l'Ouest - Site Saint-Herblain

    Saint-Herblain, Pays de la Loire Region, 44805

    Recruiting

  • Institut Gustave Roussy

    Villejuif, Île-de-France Region, 94805

    Recruiting

Other trials in France

Australia2 sites, 2 recruiting

  • Peter MacCallum Cancer Centre

    Melbourne, Victoria, 3000

    Recruiting

  • Scientia Clinical Research

    Randwick, New South Wales, 2031

    Recruiting

Other trials in Australia

South Korea2 sites, 2 recruiting

  • Asan Medical Center (AMC)

    Seoul, Seoul, 05505

    Recruiting

  • Seoul National University Hospital

    Seoul, 03080

    Recruiting

Other trials in South Korea

About this study

Official title: A Phase 1a/1b Open-Label Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of BBO-10203 in Subjects With Advanced Solid Tumors (The BREAKER-101 Study)

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.

Read the detailed description

This is an open-label, multi-center Phase 1a/1b study designed to evaluate the safety, tolerability, preliminary antitumor activity, and PK of BBO-10203 as a single agent and in combination with Trastuzumab, Fulvestrant +/- Ribociclib, or FOLFOX + Bevacizumab in patients with locally advanced unresectable or metastatic (ie, advanced) solid tumors. The study includes a dose escalation phase and an expansion phase.

Being tested
BBO-10203, Trastuzumab, Fulvestrant, Ribociclib, FOLFOX
Keywords
BREAKER-101, BridgeBio Oncology Therapeutics, BBOT, Phase1, Phase 1a/1b, Trastuzumab, Breast, Colorectal, Non-Small Cell Lung Cancer, CRC, NSCLC, Metastatic Cancer, Advanced Cancer, HER2-positive, HR-positive, HR-positive, HER2-negative, HER2-negative
Medical subject headings
Breast Neoplasms, Lung Neoplasms, Colorectal Neoplasms, Carcinoma, Non-Small-Cell Lung, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BBO-10203Drug

    Participants will receive assigned dose of BBO-10203 orally once daily

  • TrastuzumabDrug

    Participants will receive trastuzumab as infusion or subcutaneous injection every 21 days

  • FulvestrantDrug

    Patients will receive Fulvestrant as an intramuscular injection every 28 days (additional dose on C1D15)

  • RibociclibDrug

    Patients will receive Ribociclib orally once a day (21 days on treatment, 7 days off)

  • FOLFOXDrug

    Patients will receive FOLFOX as infusion every 14 days

  • BevacizumabDrug

    Patients will receive bevacizumab as infusion every 28 days

Study groups in NCT06625775
Study groupRoleWhat they receive
BBO-10203ExperimentalParticipants enrolled in this cohort will receive BBO-10203 tablets orally (different dose levels will be evaluated) once daily as monotherapy. This cohort will enroll patients with HER2-positive advanced breast cancer, HR-positive HER2-negative advanced breast cancer, advanced colorectal cancer, and advanced lung cancer.
Receives: Drug: BBO-10203
BBO-10203 + TrastuzumabExperimentalParticipants enrolled in this cohort will receive BBO-10203 tablets orally in combination with trastuzumab. This cohort will enroll patients with HER2-positive advanced breast cancer.
Receives: Drug: BBO-10203; Drug: Trastuzumab
BBO-10203 + FulvestrantExperimentalParticipants enrolled in this cohort will receive BBO-10203 tablets orally in combination with fulvestrant. This cohort will enroll patients with HR-positive, HER2-negative advanced breast cancer.
Receives: Drug: BBO-10203; Drug: Fulvestrant; Drug: Ribociclib
BBO10203 + Fulvestrant + RibociclibExperimentalParticipants enrolled in this cohort will receive BBO-10203 tablets orally in combination with fulvestrant and ribociclib as determined in the dose escalation. This cohort will enroll patients with HR-positive, HER2-negative advanced breast cancer.
Receives: Drug: BBO-10203; Drug: Fulvestrant; Drug: Ribociclib
BBO10203 + FOLFOX + BevacizumabExperimentalParticipants enrolled in this cohort will receive BBO-10203 tablets orally in combination with FOLFOX and bevacizumab. This cohort will enroll patients with KRAS-mutant advanced colorectal cancer.
Receives: Drug: BBO-10203; Drug: FOLFOX; Drug: Bevacizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Determination of maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of BBO-10203 as a single agent

    Measured: Up to approximately 5 years

  2. Percentage of patients with treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and dose-limiting toxicities (DLTs)

    Measured: Up to approximately 5 years

  3. Recommended BBO-10203 dose in combination with trastuzumab, fulvestrant +/- ribociclib, and FOLFOX + bevacizumab

    Measured: Up to approximately 5 years

Secondary outcomes (8)

  1. Clinical benefit rate (CBR) as assessed by RECIST v1.1.

    Measured: Up to approximately 5 years

  2. Duration of response (DOR) as assessed by RECIST v1.1.

    Measured: Up to approximately 5 years

  3. Progression-free survival (PFS) as assessed by RECIST v1.1

    Measured: Up to approximately 5 years

  4. Overall survival (OS)

    Measured: Up to approximately 5 years

  5. Area under the concentration-time curve (AUC

    Measured: Predose (within 30 minutes) of C1D1 until up to approximately 5 years

  6. Maximum plasma drug concentration (Cmax)

    Measured: Predose (within 30 minutes) of C1D1 until up to approximately 5 years

  7. Time for maximum plasma drug concentration (Tmax)

    Measured: Predose (within 30 minutes) of C1D1 until up to approximately 5 years

  8. Objective response rate (ORR) as assessed by RECIST v1.1 for patients with measurable disease

    Measured: Up to approximately 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Oct 2024
  2. Study start29 Oct 2024
  3. Primary completionNov 2028 (estimated)
  4. Study completionNov 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
392 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06625775
Sponsor's protocol ID
TBBO10203-101
Other IDs
2024-519445-29-00, BREAKER-101
Status last verified
Sep 2026
First submitted
1 Oct 2024
Last updated
1 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BBO-10203, Trastuzumab and Fulvestrant in people with Solid Tumor, Adult and Metastatic Breast Cancer, run by TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics) at 44 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 44 sites in United States, Spain, Brazil, France, Australia and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact BBOT (BridgeBio Oncology Therapeutics) (650-405-8440, Breaker-101ct.gov@bridgebiooncology.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Determination of maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of BBO-10203 as a single agent (time frame: Up to approximately 5 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06625775.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.

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Clinical Trial NCT06625775 | AzTrials