Phase 2 studies are investigating BDC-1001 in HER2-positive gastroesophageal, colorectal, breast, and endometrial cancers.
The Food and Drug Administration (FDA) granted ODD to BDC-1001, an ISAC for the treatment of gastric cancer.
“Receiving orphan drug designation from the FDA is an important step forward in the development of BDC-1001 and reinforces the potential of BDC-1001 to address unmet needs for patients with gastric cancers,” said Edith A. Perez, MD, chief medical officer of Bolt Biotherapeutics in a press release.1
BDC-1001 is in phase 2 development for the treatment of HER2-positive colorectal, endometrial, and gastroesophageal cancers. The phase 2 study (NCT04278144) is evaluating BDC-1001, a biosimilar of trastuzumab (Herceptin) conjugated with a non-cleavable linker to a TLR7/8 agonist, as a single agent and in conjunction with nivolumab (Opdivo), a PD-1 inhibitor.
An estimated 390 patients are enrolled in the trial, which began in February 2020. The estimated study completion date is October 2026. The trial is composed of 4 parts. Part 1 evaluates BDC-1001 as a single agent and determines the maximum-tolerated dose (MTD), recommended phase 2 dose (RP2D), and maximum protocol dose (MPD). Part 3 will apply the selected dose as a monotherapy. Part 2 will evaluate the MTD of BDC-1001 when used with nivolumab, and the selected doses will be administered in Part 4.
The primary outcome measures are incidence of adverse events (AEs), incidence and nature of dose-limiting toxicities (DLTs), incidence of potential immune-related toxicities, MTD, and objective response rate (ORR) or confirmed complete or partial response.
Inclusion criteria for the trial indicates that patients must have an advanced solid tumor with documented HER2-protein expression or gene amplification. Exclusion criteria includes a history of severe hypersensitivity to the study drugs; previous treatment with a TLR 7, TLR 8, or a TLR 7/8 agonist; and impaired cardiac function or history of significant cardiac disease.2
“We look forward to advancing BDC-1001 in clinical development and bringing this novel immunotherapy to patients in need of further treatment options,” Perez said.
A second phase 2 study (NCT05954143) is evaluating BDC-1001 as a single agent and in conjunction with pertuzumab (Perjeta) for HER2-positive breast cancer treatment. The study has an estimated completion date of March 2025.3