BOLD-100 in Combination With FOLFOX for the Treatment of Advanced Solid Tumours
Condition(s) studied
Investigational drug(s) / intervention(s)
BOLD-100 +/- FOLFOX Chemotherapy (Arm VII): Arm VIIA: 500 mg/m2 BOLD-100 combined with FOLFOX; Arm VIIB: 625 mg/m2 BOLD-100 combined with FOLFOX; Arm VIIC: FOLFOX alone
BOLD-100 in combination with FOLFOX Chemotherapy (Arms I-VI): BOLD-100 at 625 mg/m2 combined with FOLFOX Chemotherapy
Study 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.
Eligibility
Primary outcome measure(s)
- Incidence and severity of adverse events ([S]AEs) — Through study completion, approximately 2 weeks after last treatment
Arms I-VI: Primary outcome measure; Arm VII: Secondary outcome measure - Incidence of dose-limiting toxicities (DLT) — Screening to 4 weeks after first treatment
Dose escalation only. - Incidence of clinically significant changes or abnormalities from Physical Examinations, ECGs, Vital Signs, Laboratory Results, ECOG performance status — Through study completion, approximately 2 weeks after last treatment
Arms I-VI: Primary outcome measure; Arm VII: Secondary outcome measure - Progression Free Survival (PFS): Arm VII — Through study completion, approximately 2 weeks after last treatment for last patient
Arm VII: Primary outcome measure - Overall Response Rate (ORR): Arm VII — Through study completion, approximately 2 weeks after last treatment for last patient
Arm VII: Primary outcome measure - Overall Survival (OS): Arm VII — Through study completion, approximately 2 weeks after last treatment for last patient
Arm VII: Primary outcome measure
Trial sites (24)
| Facility | City | Region | Status |
|---|---|---|---|
| University of California, Los Angeles | Santa Monica | California | Completed |
| Moffitt Cancer Center | Tampa | Florida | Completed |
| Cross Cancer Institue | Edmonton | Alberta | Recruiting |
| Juravinski Cancer Centre | Hamilton | Ontario | Recruiting |
| The Ottawa Hospital Cancer Centre | Ottawa | Ontario | Recruiting |
| Princess Margaret Cancer Centre | Toronto | Ontario | Recruiting |
| Jewish General Hospital | Montreal | Quebec | Recruiting |
| McGill University Health Centre Glen Site | Montreal | Quebec | Recruiting |
| Universitatsklinikum Bonn | Bonn | Germany | Recruiting |
| University Hospital of Ulm | Ulm | Germany | Recruiting |
| Mater Miserecordiae University Hospital | Dublin | Ireland | Recruiting |
| St. James Hospital | Dublin | Ireland | Recruiting |
| St. Vincent's University Hospital | Dublin | Ireland | Recruiting |
| Fondazione IRCCS "Istituto Nazionale dei Tumori | Milan | Italy | Not Yet Recruiting |
| AOU L. Vanvitelli | Naples | Italy | Not Yet Recruiting |
| Azienda Ospedaliero Universitaria Pisana | Pisa | Italy | Not Yet Recruiting |
| National Cancer Center | Goyang | South Korea | Recruiting |
| Kangbuk Samsung Hospital | Seoul | South Korea | Recruiting |
| Samsung Medical Center | Seoul | South Korea | Recruiting |
| Seoul National University Hospital | Seoul | South Korea | Recruiting |
| Severance Hospital - Yonsei University | Seoul | South Korea | Recruiting |
| Vall Hebron Institute of Oncology (VHIO) | Barcelona | Spain | Not Yet Recruiting |
| Early Phase Unit FJD START Madrid | Madrid | Spain | Not Yet Recruiting |
| Hospital 12 de Octubre | Madrid | Spain | Not Yet Recruiting |
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04421820 on ClinicalTrials.gov ↗ ← All trials in the UK