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     179  0 Kommentare Bolt Biotherapeutics Announces AACR 2021 Presentation of Boltbody Platform Mechanism of Action and Clinical Properties of Lead ISAC, BDC-1001 - Seite 2

    A Trial in Progress poster is also being presented by Manish R. Sharma, M.D. of START Midwest, a principal investigator in Bolt’s ongoing BDC-1001 Phase 1/2 trial. The poster details the design of the study: a four-part study with two dose-escalation parts and two dose-expansion parts. The study is evaluating BDC-1001 administered intravenously with or without an immune checkpoint inhibitor targeting PD-1 in up to 390 patients with HER2-expressing or HER2-amplified advanced or metastatic solid tumors. The dose escalation parts will evaluate sequential doses of BDC-1001 as a monotherapy or in combination with a PD-1 checkpoint inhibitor in a 3+3 design, with the ability to backfill up to an additional 12 patients in each dose cohort. The dose expansion parts will evaluate the recommended Phase 2 dose as monotherapy or in combination with a PD-1 checkpoint inhibitor in four cohorts of patients.

    The primary objective of the dose escalation portion of the study is to assess safety as measured by the incidence of adverse events and serious adverse events; dose-limiting toxicities within the 3+3 design; and potential immune-related toxicities and determine the recommended phase 2 dose. Secondary objectives will evaluate pharmacokinetic parameters and pharmacodynamic biomarkers in tumor tissue and in peripheral blood associated with drug exposure. These exploratory studies will help reinforce the ISAC mechanism of action in humans and seek to identify biomarkers associated with BDC-1001 biological activity with or without an immune checkpoint inhibitor.

    In January, Bolt presented a preliminary clinical update on the first 20 patients that showed early signs of clinical activity, including stable disease in several patients and a confirmed partial response by RECIST, and acceptable safety with all 20 patients completing their dose-limiting toxicity (DLT) evaluation period without DLTs or drug-related serious adverse events. Treatment-emergent adverse events deemed to be related to BDC-1001 have been mild or moderate in severity, including mild infusion-related reactions without interruption to dosing. Bolt expects to provide an update on the trial sometime in the second half of 2021.

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    Bolt Biotherapeutics Announces AACR 2021 Presentation of Boltbody Platform Mechanism of Action and Clinical Properties of Lead ISAC, BDC-1001 - Seite 2 Bolt’s first-in-class clinical candidate, BDC-1001, is a novel HER2-targeting, TLR 7/8 immune-stimulating antibody conjugate (ISAC) currently in an ongoing Phase 1/2 first-in-human studyREDWOOD CITY, Calif., April 10, 2021 (GLOBE NEWSWIRE) - Bolt …