On October 15, 2026 Bold Therapeutics, a clinical-stage biopharmaceutical company developing novel metallotherapeutics for difficult-to-treat cancers, reported the enrollment of 60 patients in Arm VII of its Phase 2 BOLD-100-001 trial (NCT04421820). Arm VII evaluates BOLD-100 in combination with FOLFOX-based chemotherapy in patients with second-line metastatic colorectal cancer (mCRC).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
Arm VII is a randomized, controlled study comparing two dose levels of BOLD-100 (500 mg/m² and 625 mg/m²), each given with FOLFOX-based standard of care (SOC), against FOLFOX-based SOC alone. The study evaluates efficacy, safety, and tolerability. With 60 patients enrolled, Arm VII has reached the midpoint of its planned enrollment of 120 patients. This milestone triggers a pre-specified interim analysis comparing outcomes across the three treatment groups. The Company expects interim results before the end of 2026.
Bold is currently enrolling patients across more than 25 clinical sites in Canada, South Korea, Ireland, Germany, Italy, Spain, and the United Kingdom. This diverse global cohort supports the ongoing clinical development of BOLD-100 for an indication with significant unmet medical need.
"Second-line metastatic colorectal cancer remains a difficult-to-treat disease. Patients who progress after first-line treatment need access to innovative therapies like BOLD-100 as outcomes in this setting remain poor," said Dr. Grainne O’Kane, Professor of Medical Oncology, St. Vincent’s University Hospital, Dublin, Ireland. "Reaching the enrollment midpoint of this clinical trial is an important step. The interim analysis will give us a first look at how BOLD-100 performs alongside standard chemotherapy."
"This milestone reflects the commitment of our employees, investigators, site teams, and the patients and families who chose to take part in this study," said Glenn Walthall, Chairman and Interim CEO of Bold Therapeutics.
Bold Therapeutics will attend BIO-Europe 2026 in Cologne, Germany, from November 9 to 11, where the Company will meet with current and prospective collaborators. The Company plans to share interim data from Arm VII in partnering meetings at the event.
(Press release, Bold Therapeutics, OCT 15, 2026, View Source [SID1234673500])