A First-in-human Study Using BDC-1001 in Advanced and HER2-Expressing Solid Tumors

  • STATUS
    Recruiting
  • participants needed
    390
  • sponsor
    Bolt Biotherapeutics, Inc.
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Updated on 19 February 2024
See if I qualify
cancer
measurable disease
metastasis
solid tumour
pembrolizumab
solid tumor
advanced solid tumor
advanced malignant solid tumor
gene amplification
gastric tumor
exhausted
HER2

Summary

A first-in-human study using BDC-1001 in HER2 expressing advanced malignancies

Description

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 for Part 3 and Phase 2 (RP2D). 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 for Part 4 and Phase 2 (RP2D). In Part 4, the selected dose will be administered in combination with pembrolizumab to patients with selected advanced malignancies.

Details
Condition Breast Cancer, Breast Cancer, Gastric Cancer, Gastric Cancer, Neoplasm, Metastatic
Age 18years - 100years
Treatment Pembrolizumab, BDC-1001
Clinical Study IdentifierNCT04278144
SponsorBolt Biotherapeutics, Inc.
Last Modified on19 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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
For the combination portion of the study, previous treatment with an anti-PD1 or antiPD -L1 therapy
Impaired cardiac function or history of clinically significant cardiac disease
Human Immunodeficiency virus (HIV) infection, active hepatitis B infection, or hepatitis C infection
Untreated central nervous system (CNS), epidural tumor or metastasis, or brain metastasis
Other protocol defined inclusion/exclusion criteria may apply
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cancer
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gene amplification
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exhausted
HER2

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