๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-05-15

BOLD-100 in Combination With FOLFOX for the Treatment of Advanced Solid Tumours (NCT04421820)

A Phase 1b/2a Dose Escalation Study of BOLD-100 in Combination With FOLFOX Chemotherapy in Patients With Advanced Solid Tumours

๐ŸŸข Recruiting Phase1 / Phase2 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: Bold Therapeutics, Inc.

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

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.

Who can join: Review the eligibility criteria below.

Location: University of California, Los Angeles โ€” Santa Monica, California

Age range: 18 Years

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (24 Sites)

  • University of California, Los Angeles โ€” Santa Monica, California
  • Moffitt Cancer Center โ€” Tampa, Florida
  • Cross Cancer Institue โ€” Edmonton, Alberta
  • Juravinski Cancer Centre โ€” Hamilton, Ontario
  • The Ottawa Hospital Cancer Centre โ€” Ottawa, Ontario
  • Princess Margaret Cancer Centre โ€” Toronto, Ontario
  • Jewish General Hospital โ€” Montreal, Quebec
  • McGill University Health Centre Glen Site โ€” Montreal, Quebec
  • Universitatsklinikum Bonn โ€” Bonn,
  • University Hospital of Ulm โ€” Ulm,
  • Mater Miserecordiae University Hospital โ€” Dublin,
  • St. James Hospital โ€” Dublin,
  • St. Vincent's University Hospital โ€” Dublin,
  • Fondazione IRCCS "Istituto Nazionale dei Tumori โ€” Milan,
  • AOU L. Vanvitelli โ€” Naples,
  • Azienda Ospedaliero Universitaria Pisana โ€” Pisa,
  • National Cancer Center โ€” Goyang,
  • Kangbuk Samsung Hospital โ€” Seoul,
  • Samsung Medical Center โ€” Seoul,
  • Seoul National University Hospital โ€” Seoul,
  • Severance Hospital - Yonsei University โ€” Seoul,
  • Vall Hebron Institute of Oncology (VHIO) โ€” Barcelona,
  • Early Phase Unit FJD START Madrid โ€” Madrid,
  • Hospital 12 de Octubre โ€” Madrid,

๐Ÿ“ž Contact the Study Coordinator

Phone: (604) 262-9899

Email: clinical@bold-therapeutics.com

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—