BOLD-100 Trial Receives FDA Clearance for Treatment of Advanced GI Cancers


The Food and Drug Administration gave clearance to Bold Therapeutics for a phase 1b/2a trial examining treatments for advanced GI cancers.

In early July, the Food and Drug Administration (FDA) cleared an Investigational New Drug Application (IND) amendment for BOLD-100-001, a clinical trial examining treatments for advanced gastrointestinal (GI) cancers.

The IND allowed for new trial sites to be added in the U.S. – including H. Lee Moffitt Cancer Center & Research Institute in Tampa, Florida and the University of California, Los Angeles in Los Angeles, California.

"This FDA clearance is a major milestone for Bold Therapeutics as it allows us to more rapidly enroll patients and further diversify our patient population" said Jim Pankovich, executive vice president of clinical development at Bold Therapeutics, in a release. "Our corporate mission is to address significant unmet needs in oncology, and we are optimistic that BOLD-100 can meaningfully improve outcomes in patients with these difficult-to-treat cancers."

BOLD-100-001 is a two-stage study enrolling patients at six sites that will determine the safety and efficacy of BOLD-100 when combined with FOLFOX (5-fluorouracil, leucovorin, oxaliplatin) chemotherapy. The treatment will be evaluated in patients with advanced gastric, pancreatic, colorectal and bile duct cancers.

The effects of BOLD-100 on the body result in cell death in both sensitive and resistant cancers, which could improve outcomes when combined with other anti-cancer therapies.

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