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Bolt Biotherapeutics Highlights Comprehensive Clinical Data from Phase 1 Dose-Escalation Trial of BDC-1001 as Monotherapy and in Combination with Nivolumab in HER2-Expressing Tumors at 2023 ASCO Annual Meeting

  • Treatment with BDC-1001 at the recommended Phase 2 dose (RP2D) resulted in 29% objective response rate in evaluable patients with HER2-positive tumors, in both monotherapy and in combination with nivolumab
  • 20 mg/kg dosed every other week (q2w) was selected as the RP2D
  • BDC-1001 advancing to a focused Phase 2 clinical program in four HER2-positive tumor types: colorectal, endometrial, gastroesophageal, and breast

Excerpt from the Press Release:

Bolt Biotherapeutics, Inc. (Nasdaq: BOLT) today announced the data from its Phase 1 dose-escalation clinical trial of BDC-1001 that will be presented in a poster session at the American Society of Clinical Oncology (ASCO) 2023 Annual Meeting, being held at McCormick Place in Chicago, Illinois and virtually from June 2-6, 2023.

BDC-1001 is an investigational Immune-Stimulating Antibody Conjugate (ISAC) in development for the treatment of patients with human epidermal growth factor receptor 2 (HER2)-expressing cancer. BDC-1001 comprises a HER2-targeting biosimilar of trastuzumab conjugated with a non-cleavable linker to a proprietary TLR7/8 agonist. The Phase 1 dose-escalation trial enrolled 131 patients with 16 different HER2-expressing solid tumor types across 18 dose levels in two arms, monotherapy and in combination with nivolumab. At enrollment, all patients entered in the study had evidence of tumor progression following prior standard of care treatments, and a majority of the patients were heavily pre-treated.

“BDC-1001 has demonstrated a favorable safety profile and encouraging efficacy including multiple objective responses and long-term stable disease, as well as biomarker evidence of immune activation that support our ISAC mechanism of action,” said Edith A. Perez, M.D., Chief Medical Officer of Bolt Biotherapeutics. “Furthermore, these data support the initiation of our Phase 2 clinical program in four HER2-positive tumor types this year.”

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