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RecruitingPhase 1

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

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)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This is the first study of BBO-10203 in people. It tests safety, side effects, and how the body handles the drug, alone or with other cancer drugs. It is for people with certain types of breast, colon or rectal, or lung cancer that have spread or cannot be removed by surgery.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have advanced breast cancer that is HER2-positive or hormone receptor (HR)-positive/HER2-negative, or advanced colon, rectal, or non-small cell lung cancer with a KRAS gene change.
  • Have cancer that can be measured by study rules. HR-positive/HER2-negative breast cancer only in the bones may also qualify. Be fully active or able to do light work.
  • If cancer has spread to the brain, it must be stable. For BBO-10203 with trastuzumab, a heart scan must show that the heart pumps well enough.
  • For HER2-positive breast cancer: have had at least 2 rounds of HER2-targeted treatment. One round is allowed if no other standard treatment is available in your region.
  • For BBO-10203 alone in the other listed cancers: cancer must have grown or returned after at least one standard treatment, or the study doctor must think standard treatment is unlikely to help or would be too hard to tolerate.
  • For BBO-10203 with fulvestrant in HR-positive/HER2-negative breast cancer: have a confirmed PIK3CA gene change and have received a CDK4/6 inhibitor, a type of cancer drug.
  • For BBO-10203 with fulvestrant and ribociclib in HR-positive/HER2-negative breast cancer: have a confirmed PIK3CA gene change and no prior treatment that travels through the body for advanced breast cancer.
  • For BBO-10203 with FOLFOX and bevacizumab in KRAS-mutant colon or rectal cancer: one prior round of treatment containing irinotecan for advanced cancer is allowed but not required.

Who can't join

  • For KRAS-mutant colon or rectal cancer: tumors with any of these lab findings: KRAS G12R, BRAF V600E, extra copies of HER2 (HER2amp), or certain problems repairing DNA (dMMR/MSI-H).
  • For KRAS-mutant non-small cell lung cancer: KRAS G12R or other cancer-driving gene changes that can be targeted with drugs, such as changes in EGFR, ALK, ROS1, BRAF, RET, MET, NTRK, or HER2.
  • Cancer that has spread to the brain and is untreated or not stable.
  • Other rules for joining or being excluded are listed in the study plan.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Study sites (19)

CA

FL

IN

MA

MO

NY

TN

TX

WA

WI