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

NCT06625775
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Phase
Phase 1
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Recruitment status
Recruiting
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Participants
392
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Lead sponsor
TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics)
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Start date
2024-10-29
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Number of sites
40
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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.
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Short title
Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors
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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)
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Control arm
Open label
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 1
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Study type
Interventional
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Completion date
2028-11-01
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First posted
2024-10-03
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Registry last updated
2026-06-23
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Primary completion date
2028-11-01
clinicaltrials.gov
Start date
2024-10-29
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Participants
392
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Participant count basis
Estimated
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Planned participants
392
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Protocol amendments
5
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Number of sites
40
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics)
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Source registry
ClinicalTrials.gov
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Registry ID
NCT06625775
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ClinicalTrials.gov ID
NCT06625775
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Registry record
Open registry record
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Allocation
Not randomised
Model
Parallel groups
Purpose
Treatment
Masking
No masking
Sources for study design
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  1. Determination of maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of BBO-10203 as a single agent

    Timeframe: Up to approximately 5 years

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

    Timeframe: Up to approximately 5 years

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

    Timeframe: Up to approximately 5 years

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

    Timeframe: Up to approximately 5 years

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

    Timeframe: Up to approximately 5 years

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

    Timeframe: Up to approximately 5 years

  4. Overall survival (OS)

    Timeframe: Up to approximately 5 years

  5. Area under the concentration-time curve (AUC

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

  6. Maximum plasma drug concentration (Cmax)

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

  7. Time for maximum plasma drug concentration (Tmax)

    Timeframe: 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

    Timeframe: Up to approximately 5 years

Sources for outcomes
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Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

  • 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)
  • 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

  • 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

Sources for eligibility
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  • City of Hope Comprehensive Cancer CenterDuarte, United StatesRecruiting
  • University of California Los AngelesLos Angeles, United StatesRecruiting
  • University of California San Diego Moores Cancer CenterSan Diego, United StatesRecruiting
  • UCSF Helen Diller Family Comprehensive Cancer CenterSan Francisco, United StatesRecruiting
  • Moffitt Cancer CenterTampa, United StatesRecruiting
  • Indiana University Simon Comprehensive Cancer CenterIndianapolis, United StatesRecruiting
  • Massachusetts General HospitalBoston, United StatesRecruiting
  • Dana-Farber Cancer InsituteBoston, United StatesRecruiting
  • St. Lukes Hospital of Kansas CityKansas City, United StatesRecruiting
  • Washington University School of MedicineSt Louis, United StatesRecruiting
  • Columbia University Irving Medical CenterNew York, United StatesRecruiting
  • Memorial Sloan Kettering Cancer CenterNew York, United StatesRecruiting
  • SCRI Oncology PartnersNashville, United StatesRecruiting
  • SCRI at Mary CrowleyDallas, United StatesRecruiting
  • University of Texas Southwestern Medical CenterDallas, United StatesRecruiting
  • The University of Texas MD Anderson Cancer CenterHouston, United StatesRecruiting
  • University of Texas San Antonio (UTSA)San Antonio, United StatesRecruiting
  • Fred Hutchinson Cancer CenterSeattle, United StatesRecruiting
  • Wisconsin Institute for Medical ResearchMadison, United StatesRecruiting
  • Scientia Clinical ResearchRandwick, AustraliaRecruiting
  • Peter MacCallum Cancer CentreMelbourne, AustraliaRecruiting
  • FUTTURA OncologiaPorto Alegre, BrazilRecruiting
  • Hospital São Lucas da PUCRSPorto Alegre, BrazilRecruiting
  • Clinica de Pesquisas e Centro de Estudos Em Oncologia Ginecologica e Mamaria LtdaSão Paulo, BrazilRecruiting
  • IEPE - Unimed SorocabaSorocaba, BrazilRecruiting

And 15 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

  • 2024-519445-29-00
  • BREAKER-101
Sources for references
clinicaltrials.gov

Related records

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Lead sponsors (1)

Conditions (10)

Targets (5)