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

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.

Trial Details

NCT ID
NCT04421820
Phase
PHASE1 / PHASE2
Sponsor
Bold Therapeutics, Inc.
Status
RECRUITING
Cancer Type
Pancreatic Cancer
Interventions
  • BOLD-100 +/- FOLFOX Chemotherapy (Arm VII)
  • BOLD-100 in combination with FOLFOX Chemotherapy (Arms I-VI)
Locations (sample)
  • Santa Monica, California, United States|34.01949,-118.49138
  • Tampa, Florida, United States|27.94752,-82.45843
  • Edmonton, Alberta, Canada|53.55014,-113.46871
  • Hamilton, Ontario, Canada|43.25011,-79.84963
  • Ottawa, Ontario, Canada|45.41117,-75.69812

Key Eligibility Criteria

  • Be 18 years or older.
  • Be male or non-pregnant females who agree to comply with applicable contraceptive requirements of the protocol.
  • Histologically and/or cytologically confirmed gastrointestinal tumours that are metastatic or unresectable, and are subject to receive FOLFOX ± Bev…
  • Have measurable disease according to RECIST v1.1.

For full eligibility, visit ClinicalTrials.gov.

Check If You May Be Eligible

Trialify translates complex eligibility criteria into plain yes-or-no questions to help you understand if this trial might be right for you.

Find Pancreatic Cancer Trials on Trialify →