BDC-1001

DRUG4 trials

Sponsors

Bolt Biotherapeutics Inc., Bolt Biotherapeutics, Inc.

Conditions

Advanced HER2-Expressing Solid Tumors.HER2-positive Breast CancerHER2-positive Colorectal CancerHER2-positive Endometrial CancerHER2-positive Gastroesophageal CancerHER2-positive Solid TumorsHUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2–POSITIVE METASTATIC BREAST CANCERMetastatic Breast Cancer

Phase 1

A First-in-human Study Using BDC-1001 as a Single Agent and in Combination With Nivolumab in Advanced HER2-Expressing Solid Tumors

TerminatedNCT04278144

Bolt Biotherapeutics, Inc.HER2-positive Breast Cancer, HER2-positive Colorectal Cancer, HER2-positive Endometrial Cancer +2

Start: 2020-02-24End: 2025-02-14Updated: 2025-09-15

Phase 1/2 Study of BDC-1001 as a Single Agent and in Combination with Nivolumab in Patients with Advanced HER2-Expressing Solid Tumors

CompletedCTIS2024-518411-19-00

Bolt Biotherapeutics Inc.Advanced HER2-Expressing Solid Tumors.

Start: 2023-12-04End: 2025-02-14Target: 15Updated: 2025-03-05

Phase 2

Trial of BDC-1001 +/- Pertuzumab in Subjects With HER2-Positive Metastatic Breast Cancer

TerminatedNCT05954143

Bolt Biotherapeutics, Inc.HER2-positive Breast Cancer, Metastatic Breast Cancer

Start: 2023-11-30End: 2024-09-25Updated: 2025-11-20

A Phase 2, Multi-Center, Randomized, Open-Label Trial of BDC-1001 as Single Agent and in Combination with Pertuzumab in Subjects with Human Epidermal Growth Factor Receptor 2–Positive Metastatic Breast Cancer Previously Treated with Trastuzumab Deruxtecan

CompletedCTIS2023-506038-65-00

Bolt Biotherapeutics Inc.HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2–POSITIVE METASTATIC BREAST CANCER

Start: 2024-04-15End: 2024-05-14Target: 36Updated: 2024-03-12

Related Papers

Phase 2 study of novel HER2-targeting, TLR7/8 immune-stimulating antibody conjugate (ISAC) BDC-1001 (trastuzumab imbotolimod) +/- pertuzumab (P) in patients (pts) with HER2-positive metastatic breast cancer (MBC) previously treated with trastuzumab deruxtecan (T-DXd).

Journal of Clinical Oncology2024-06-011 citations

Abstract PO1-20-06: Phase 2 study of novel HER2-targeting, TLR7/8 immune-stimulating antibody conjugate (ISAC) BDC-1001 +/- pertuzumab in patients with HER2-positive metastatic breast cancer (MBC) previously treated with trastuzumab deruxtecan

Cancer Research2024-05-02

716 Phase 2 study of the HER2-targeting TLR7/8 immune stimulating antibody conjugate (ISAC) BDC-1001 monotherapy +/- nivolumab in patients with HER2+ colorectal, endometrial, or gastroesophageal cancer

Regular and Young Investigator Award Abstracts2023-10-311 citations

A phase 1/2 study of a first-in-human immune-stimulating antibody conjugate (ISAC) BDC-1001 in patients with advanced HER2-expressing solid tumors.

Journal of Clinical Oncology2023-06-0140 citations

Abstract CT218: Phase 1/2 study of a novel HER2 targeting TLR7/8 immune-stimulating antibody conjugate (ISAC), BDC-1001, alone and in combination with pembrolizumab (pembro) in patients (pts) with HER2-expressing advanced solid tumors

Cancer Research2021-07-014 citations

Preliminary results from a phase 1/2 study of BDC-1001, a novel HER2 targeting TLR7/8 immune-stimulating antibody conjugate (ISAC), in patients (pts) with advanced HER2-expressing solid tumors.

Journal of Clinical Oncology2021-05-2044 citations

Abstract OT-03-02: Phase 1/2 study of a novel HER2 targeting TLR7/8 immune-stimulating antibody conjugate (ISAC), BDC-1001, as a single agent and in combination with an immune checkpoint inhibitor in patients with advanced HER2-expressing solid tumors

Cancer Research2021-02-1517 citations

401 Phase 1/2 study of novel HER2-targeting, TLR7/8 immune-stimulating antibody conjugate (ISAC) BDC-1001 with or without immune checkpoint inhibitor in patients with advanced HER2-expressing solid tumors

Regular and Young Investigator Award Abstracts2020-11-018 citations

605 Systemically administered HER2-targeted ISACs provoke a rapid, local response that engages the innate and adaptive arms of the immune system to eradicate tumors in preclinical models

Regular and Young Investigator Award Abstracts2020-11-015 citations

603 Covalent attachment of a TLR7/8 agonist to tumor-targeting antibodies drives potent anti-tumor efficacy by synergistically activating FcgR- and TLR- signaling and enables safe systemic administration

Regular and Young Investigator Award Abstracts2020-11-011 citations