BOLD-100 in Combination With FOLFOX for the Treatment of Advanced Solid Tumours
Start Date
8/28/2020
Completion Date
9/1/2026
Summary
BOLD-100 is an intravenously administered sterile solution containing the ruthenium-based small molecule. BOLD-100 has been shown to preferentially decrease the expression of GRP78 in tumour cells and ER stressed cells when compared to normal cells. BOLD-100 will be combined with cytotoxic FOLFOX chemotherapy in this study, with a dose escalation cohort to ensure tolerability and safety, followed by a cohort expansion phase.
Detailed Description
BOLD-100 is a novel, targeted anti-cancer therapy which is an intravenously administered small molecule drug. In a previous Phase 1 study (NCT01415297) BOLD-100 showed low toxicity with minimal hematological issues as well as some potential anti-tumour activity. The lack of observed hematological toxicity and neurotoxicity position BOLD-100 well for use in combination with a broad range of standard-of-care (SOC) chemotherapy regimens. This is a prospective, multicenter non-randomized Phase 1b/2a dose escalation \& expanded cohort study of BOLD-100 in patients with advanced gastrointestinal malignancies (colorectal, pancreatic, gastric cancers, and cholangiocarcinoma) receiving standard-of-care FOLFOX chemotherapy. Enrollment in Arms I - VI is closed to enrollment. Colorectal cancer (ARM VII) for patients who are oxaliplatin naïve and have received only 1 prior line of therapy in the metastatic setting. Within this arm, participants will be randomized to one of two dose levels of BOLD-100 - either 500 mg/m2 or 625 mg/m2 in combination with FOLFOX or FOLFOX alone, in a 1:1:1 ratio. Participants enrolled into Arm VII will complete quality of life questionnaires examining general quality of life and neuropathy associated quality of life parameters.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
BOLD-100 +/- FOLFOX Chemotherapy (Arm VII)
BOLD-100 in combination with FOLFOX Chemotherapy (Arms I-VI)
Conditions
Locations
University of California, Los Angeles
Santa Monica, California 90095
United States
Moffitt Cancer Center
Tampa, Florida 33612
United States
Cross Cancer Institue
Edmonton, Alberta
Canada
Juravinski Cancer Centre
Hamilton, Ontario
Canada
The Ottawa Hospital Cancer Centre
Ottawa, Ontario
Canada
Princess Margaret Cancer Centre
Toronto, Ontario
Canada
Jewish General Hospital
Montreal, Quebec
Canada
McGill University Health Centre Glen Site
Montreal, Quebec
Canada
Universitatsklinikum Bonn
Bonn,
Germany
University Hospital of Ulm
Ulm,
Germany
Mater Miserecordiae University Hospital
Dublin,
Ireland
St. James Hospital
Dublin,
Ireland
St. Vincent's University Hospital
Dublin,
Ireland
Fondazione IRCCS "Istituto Nazionale dei Tumori
Milan,
Italy
AOU L. Vanvitelli
Naples,
Italy
Azienda Ospedaliero Universitaria Pisana
Pisa,
Italy
National Cancer Center
Goyang,
South Korea
Kangbuk Samsung Hospital
Seoul,
South Korea
Samsung Medical Center
Seoul,
South Korea
Seoul National University Hospital
Seoul,
South Korea
Severance Hospital - Yonsei University
Seoul,
South Korea
Vall Hebron Institute of Oncology (VHIO)
Barcelona,
Spain
Early Phase Unit FJD START Madrid
Madrid,
Spain
Hospital 12 de Octubre
Madrid,
Spain