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RecruitingLast updated: 18 November 2024

BREAKER-101: This trial is evaluating an oral medication (called BBO-10203) by itself and in combination with targeted therapy (called trastuzumab) in people with advanced solid cancersA Phase 1a/1b Study of the PI3Kα:RAS Breaker BBO-10203 in Subjects With Advanced Solid Tumors (The BREAKER-101 Study)

Clinical summary

Summary

This study will evaluate how safe and tolerable a new medicine called BBO-10203 is, as well as its preliminary effectiveness, in people with:

  • Locally advanced, unresectable or metastatic HER2+ advanced breast cancer (aBC)
  • HR+/HER2- advanced breast cancer
  • KRA mutant advanced colorectal cancer (aCRC), or
  • KRAS mutant advanced non-small cell lung cancer (aNSCLC).

The study has a dose escalation phase and an expansion phase.

Cohort 1a - Monotherapy Dose Escalation/Cohort Expansion

Participants enrolled in this cohort will enroll patients will receive BBO-10203 tablets orally (different dose levels will be evaluated) once daily (QD) as monotherapy (by itself). This cohort will enrol patients with advanced breast cancer, advanced colorectal cancer, and advanced long cancer.

Cohort 1b - BBO-10203 Combination Dose Expansion

Participants enrolled in this cohort will receive BBO-10203 tablets orally QD in combination with trastuzumab targeted therapy (via IV infusion or an injection under the skin). This cohort will enrol patients with advanced breast cancer.

Combination Dose Escalation

Participants enrolled in this cohort will receive BBO-10203 tablets orally (different dose levels will be evaluated) QD in combination with trastuzumab targeted therapy (via IV infusion or an injection under the skin). This cohort will enrol patients with advanced breast cancer.

Conditions

This trial is treating patients with advanced solid cancers of the breast, lung and bowel

Cancer

Multi-Cancer Multi-Cancer

Age

People18+

Phase

I

Trial Acronym

BREAKER-101

More information

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Trial sponsor

TheRas, Inc., d/b/a BridgeBio Oncology Therapeutics

Scientific Title

A Phase 1a/1b Study of the PI3Kα:RAS Breaker BBO-10203 in Subjects With Advanced Solid Tumors (The BREAKER-101 Study)

Eligibility

Inclusion

  • 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
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1
  • Adequate LVEF assessed by ECHO or MUGA
  • 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).
  • Patients with HR-positive, HER2-negative aBC, KRAS mutant aCRC or aNSCLC: Must have progression on, or disease recurrence after, all available SoC treatments or in the opinion of the investigator, would be unlikely to tolerate or derive clinically meaningful benefit from appropriate SoC therapy.

Exclusion

  • Patients with HER2+ aBC who have had more than 1 prior line of therapy with an antibody-drug conjugate
  • Patients with KRAS mutant aCRC who have BRAFV600E mutation, HER2amp, or dMMR/MSI-H tumors
  • Patients with KRAS mutant aNSCLC who have tumors with other targetable driver mutations (eg, EGFR, anaplastic lymphoma kinase, ROS1/BRAF/RET/MET/EGFR exon20 insertion/NTRK/HER2)
  • Patients with untreated brain metastases (exceptions apply for HER2+ aBC per protocol)

Other inclusion/exclusion criteria are specified in the protocol

Inclusion

  • Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
  • Your cancer has not spread to other parts of the body.
  • Your cancer has not spread to other parts of the body, but it is not possible to perform surgery to remove it.
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • You are able to swallow medication by mouth.

Exclusion

  • You have had certain treatments, surgical procedures or drugs.
Message

There may be additional criteria to what is listed here, speak to your doctor to confirm whether this trial is right for you.

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Recruiting hospitals

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