Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors
Start Date
10/29/2024
Completion Date
11/1/2028
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.
Detailed Description
This is an open-label, multi-center Phase 1a/1b study designed to evaluate the safety, tolerability, preliminary antitumor activity, and PK of BBO-10203 as a single agent and in combination with Trastuzumab, Fulvestrant +/- Ribociclib, or FOLFOX + Bevacizumab in patients with locally advanced unresectable or metastatic (ie, advanced) solid tumors. The study includes a dose escalation phase and an expansion phase.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
BBO-10203
Trastuzumab
Fulvestrant
Ribociclib
FOLFOX
Bevacizumab
Conditions
Locations
City of Hope Comprehensive Cancer Center
Duarte, California 91010
United States
University of California Los Angeles
Los Angeles, California 90095
United States
University of California San Diego Moores Cancer Center
San Diego, California 92093
United States
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California 94158
United States
Moffitt Cancer Center
Tampa, Florida 33612
United States
Indiana University Simon Comprehensive Cancer Center
Indianapolis, Indiana 46202
United States
Massachusetts General Hospital
Boston, Massachusetts 02114
United States
Dana-Farber Cancer Insitute
Boston, Massachusetts 02215
United States
St. Lukes Hospital of Kansas City
Kansas City, Missouri 64111
United States
Washington University School of Medicine
St Louis, Missouri 63110
United States
Columbia University Irving Medical Center
New York, New York 10032
United States
Memorial Sloan Kettering Cancer Center
New York, New York 10065
United States
SCRI Oncology Partners
Nashville, Tennessee 37203
United States
SCRI at Mary Crowley
Dallas, Texas 75230
United States
University of Texas Southwestern Medical Center
Dallas, Texas 75390
United States
The University of Texas MD Anderson Cancer Center
Houston, Texas 77030
United States
University of Texas San Antonio (UTSA)
San Antonio, Texas 78229
United States
Fred Hutchinson Cancer Center
Seattle, Washington 98109
United States
Wisconsin Institute for Medical Research
Madison, Wisconsin 53792
United States
Scientia Clinical Research
Randwick, New South Wales 2031
Australia
Peter MacCallum Cancer Centre
Melbourne, Victoria 3000
Australia
FUTTURA Oncologia
Porto Alegre, Rio Grande do Sul 90470
Brazil
Hospital São Lucas da PUCRS
Porto Alegre, Rio Grande do Sul 90610
Brazil
Clinica de Pesquisas e Centro de Estudos Em Oncologia Ginecologica e Mamaria Ltda
São Paulo, São Paulo 01317
Brazil
IEPE - Unimed Sorocaba
Sorocaba, São Paulo 18056
Brazil
Institut régional du Cancer de Montpellier - Val d'Aurelle
Montpellier, Occitanie 34298
France
Institut Curie - René-Huguenin Hospital
Saint-Cloud, Paris 92210
France
lnstitut de Cancérologie de l'Ouest - Site Saint-Herblain
Saint-Herblain, Pays de la Loire Region 44805
France
Institut Bergonie
Bordeaux, 33000
France
Centre Léon Bérard
Lyon, 69008
France
Institut Gustave Roussy
Villejuif, Île-de-France Region 94805
France
Hospital Universitario Vall d'Hebron
Barcelona, Catalonia 08035
Spain
Hospital Beata Maria Ana
Madrid, Madrid 28007
Spain
Hospital Quiron Madrid - NEXT Oncology
Pozuelo de Alarcón, Madrid 28223
Spain
IOB Institute of Oncology - Hospital Quironsalud Barcelona
Barcelona, 08023
Spain
START Barcelona - HM Nou Delfos Hospital
Barcelona, 08023
Spain
Hospital Universitari Arnau de Vilanova
Lleida, 25198
Spain
Hospital Universitario Fundación Jiménez Díaz
Madrid, 28040
Spain
Hospital Universitario 12 de Octubre
Madrid, 28041
Spain
Hospital Universitari i Politècnic La Fe
Valencia, 46026
Spain