Clinical trial for Solid Tumor, Adult
Official title Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors
ClinicalTrials.gov ID: NCT06625775
What this study is testing
What is BBO-10203?
An investigational oral medicine being studied as a potential treatment for advanced solid tumors in adults. It is designed to break the interaction between PI3Kα and RAS signaling pathways in cancer cells.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to find out how safe and well tolerated BBO-10203 is, and to measure how the drug behaves in the body.
- Who it's for
- Adults who have advanced solid tumors such as breast, colorectal, lung cancers, or other HER2‑related tumors.
- What's involved
- Participants will receive BBO-10203 alone or together with other cancer drugs, and will have regular visits and medical tests to monitor safety and drug levels.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Locally advanced and unresectable or metastatic HER2-positive advanced breast cancer (aBC), HR-positive/HER2-negative advanced breast cancer, KRAS...
- 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
You likely can't join if
- 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...
- Patients with untreated and/or non-stable brain metastases Other inclusion/exclusion criteria are specified in the protocol
See the full eligibility 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- Duarte, California, United States
- Los Angeles, California, United States
- San Diego, California, United States
- Tampa, Florida, United States
- Indianapolis, Indiana, United States
- Boston, Massachusetts, United States
- Kansas City, Missouri, United States
- St Louis, Missouri, United States
- New York, New York, United States
- Nashville, Tennessee, United States
- Dallas, Texas, United States
- Houston, Texas, United States
- San Antonio, Texas, United States
- Seattle, Washington, United States
- Madison, Wisconsin, United States
- Randwick, New South Wales, Australia
- Melbourne, Victoria, Australia
- Natal, Rio Grande do Norte, Brazil
- Porto Alegre, Rio Grande do Sul, Brazil
- São Paulo, São Paulo, Brazil
+ 16 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Duarte, California, United States; Los Angeles, California, United States; San Diego, California, United States; Tampa, Florida, United States; Indianapolis, Indiana, United States; Boston, Massachusetts, United States and 30 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.