Phase
Condition
Colorectal Cancer
Breast Cancer
Neoplasm Metastasis
Treatment
BBO-10203
Trastuzumab
FOLFOX
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Locally advanced and unresectable or metastatic HER2-positive advanced breast cancer (aBC), HR-positive/HER2-negative advanced breast cancer, KRAS mutant advancedcolorectal 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 whereevaluable 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 ofanti-HER2-directed therapy. Only 1 prior line is acceptable where there is no otherregionally available standard of care (SoC)
Monotherapy Cohort patients with HR-positive, HER2-negative aBC, KRAS mutant aCRC oraNSCLC: Must have progression on, or disease recurrence after at least one line ofSOC treatment or in the opinion of the investigator, would be unlikely to tolerateor derive clinically meaningful benefit from SoC therapy
BBO-10203 + Fulvestrant combination cohort patients with HR-positive, HER2-negativeaBC: 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 aBCsetting permitted
BBO-10203 + FOLFOX + Bevacizumab combination cohort patients with KRAS mutant aCRC:One prior line of irinotecan-containing therapy for locally advanced or metastaticCRC is allowed but not required
Exclusion
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 othertargetable 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 Design
Study Description
Connect with a study center
Scientia Clinical Research
Randwick, New South Wales 2031
AustraliaSite Not Available
Scientia Clinical Research
Randwick 2208285, New South Wales 2155400 2031
AustraliaActive - Recruiting
Peter MacCallum Cancer Centre
Melbourne, Victoria 3000
AustraliaSite Not Available
Peter MacCallum Cancer Centre
Melbourne 2158177, Victoria 2145234 3000
AustraliaActive - Recruiting
Hospital Universitario Fundación Jiménez Díaz
Madrid 3117735, 28040
SpainActive - Recruiting
University of California Los Angeles
Los Angeles, California 90095
United StatesSite Not Available
University of California Los Angeles
Los Angeles 5368361, California 5332921 90095
United StatesActive - Recruiting
University of California San Diego Moores Cancer Center
San Diego 5391811, California 5332921 92037
United StatesActive - Recruiting
Moffitt Cancer Center
Tampa, Florida 33612
United StatesSite Not Available
Moffitt Cancer Center
Tampa 4174757, Florida 4155751 33612
United StatesActive - Recruiting
Indiana University Simon Comprehensive Cancer Center
Indianapolis, Indiana 46202
United StatesSite Not Available
Indiana University Simon Comprehensive Cancer Center
Indianapolis 4259418, Indiana 4921868 46202
United StatesActive - Recruiting
Dana-Farber Cancer Insitute
Boston, Massachusetts 02215
United StatesSite Not Available
Massachusetts General Hospital
Boston, Massachusetts 02114
United StatesActive - Recruiting
Dana-Farber Cancer Insitute
Boston 4930956, Massachusetts 6254926 02215
United StatesActive - Recruiting
Massachusetts General Hospital
Boston 4930956, Massachusetts 6254926 02114
United StatesActive - Recruiting
Columbia University Irving Medical Center
New York, New York 10032
United StatesSite Not Available
Memorial Sloan Kettering Cancer Center
New York, New York 10065
United StatesActive - Recruiting
Columbia University Irving Medical Center
New York 5128581, New York 5128638 10032
United StatesActive - Recruiting
Memorial Sloan Kettering Cancer Center
New York 5128581, New York 5128638 10065
United StatesActive - Recruiting
SCRI Oncology Partners
Nashville, Tennessee 37203
United StatesSite Not Available
SCRI Oncology Partners
Nashville 4644585, Tennessee 4662168 37203
United StatesActive - Recruiting
Mary Crowley Cancer Research
Dallas, Texas 75230
United StatesActive - Recruiting
SCRI at Mary Crowley
Dallas, Texas 75230
United StatesSite Not Available
The University of Texas MD Anderson Cancer Center
Houston, Texas 77030
United StatesSite Not Available
University of Texas San Antonio (UTSA)
San Antonio, Texas 78229
United StatesSite Not Available
SCRI at Mary Crowley
Dallas 4684888, Texas 4736286 75230
United StatesActive - Recruiting
University of Texas Southwestern Medical Center
Dallas 4684888, Texas 4736286 75390
United StatesActive - Recruiting
The University of Texas MD Anderson Cancer Center
Houston 4699066, Texas 4736286 77030
United StatesActive - Recruiting
University of Texas San Antonio (UTSA)
San Antonio 4726206, Texas 4736286 78229
United StatesActive - Recruiting
Fred Hutchinson Cancer Center
Seattle 5809844, Washington 5815135 98109
United StatesActive - Recruiting
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