A First-in-human Study Using BDC-1001 in Advanced HER2-Expressing Solid Tumors
- Patient must have an advanced solid tumor with documented HER2-protein expression or gene amplification for which approved therapies have been exhausted or are not clinically indicated.
- Measurable disease as determined by RECIST v.1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Tumor tissue (archival or collected prior to the study start) available for exploratory biomarker evaluation.
- History of severe hypersensitivity to any ingredient of the study drug(s), including trastuzumab or other monoclonal antibody.
- Previous treatment with a TLR 7, TLR 8 or a TLR 7/8 agonist.
- Impaired cardiac function or history of clinically significant cardiac disease
- Human Immunodeficiency virus (HIV) infection, active hepatitis B infection, or hepatitis C infection.
- Active SARS-CoV-2 infection
- Untreated central nervous system (CNS), epidural tumor or metastasis, or brain metastasis.
This study has four parts. Part 1 is a dose escalation of BDC-1001 as a single agent to
determine the maximum tolerated dose (MTD), recommended Phase 2 dose (RP2D), or maximum
protocol dose (MPD) recommended for Part 3. In Part 3, the selected dose will be administered
as monotherapy to patients with selected advanced malignancies. Part 2 is a dose escalation
of BDC-1001 in combination with pembrolizumab to determine the maximum tolerated dose (MTD),
recommended Phase 2 dose (RP2D), or maximum protocol dose (MPD) recommended for Part 4. In
Part 4, the selected dose will be administered in combination with pembrolizumab to patients
with selected advanced malignancies.
Trial Phase Phase I/II
Trial Type Treatment
Bolt Biotherapeutics, Inc.
- Primary ID BBI-20201001
- Secondary IDs NCI-2020-03932
- Clinicaltrials.gov ID NCT04278144