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RECRUITING
NCT04421820
PHASE1/PHASE2

BOLD-100 in Combination With FOLFOX With or Without Bevacizumab for the Treatment of Advanced, Solid Tumours

Sponsor: Bold Therapeutics, Inc.

View on ClinicalTrials.gov

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 ± Bevacizumab chemotherapy in this study, with a dose escalation cohort to ensure tolerability and safety, followed by a cohort expansion phase. This study now includes as a treatment intervention the SOC combination FOLFOX ± Bevacizumab, if indicated.

Official title: A Phase 1b/2a Dose Escalation Study of BOLD-100 in Combination With FOLFOX Chemotherapy With or Without Bevacizumab in Patients With Advanced Solid Tumours

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

220

Start Date

2020-08-28

Completion Date

2027-12-31

Last Updated

2026-10-28

Healthy Volunteers

No

Interventions

DRUG

BOLD-100 ± FOLFOX ± Bevacizumab Chemotherapy (Arm VII)

Arm VIIA: 500 mg/m2 BOLD-100 combined with FOLFOX ± Bevacizumab; Arm VIIB: 625 mg/m2 BOLD-100 combined with FOLFOX ± Bevacizumab; Arm VIIC: FOLFOX ± Bevacizumab alone

DRUG

BOLD-100 in combination with FOLFOX Chemotherapy (Arms I-VI)

BOLD-100 at 625 mg/m2 combined with FOLFOX Chemotherapy

Locations (28)

University of California, Los Angeles

Santa Monica, California, United States

Moffitt Cancer Center

Tampa, Florida, 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

Velindre Cancer Centre Clinical Trials

Cardiff, United Kingdom

Ulster Hospital

Dundonald, United Kingdom

Royal Marsden Hospital

London, United Kingdom

Royal Marsden Hospital

Sutton, United Kingdom