Recruiting • Phasen I, II • Stufe III, IV • HER2 positiv • Post-Menopausal • Interventionell
Folgendes wird aus ClinicalTrials.gov importiert:
A first-in-human study using BDC-1001 as a single agent and in combination with nivolumab in HER2 expressing advanced malignancies
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 nivolumab 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 nivolumab to patients with selected advanced malignancies.
Breast Cancer
Interventional
390 Teilnehmer
24. Februar 2020
18 - 999
both
BDC-1001
Nivolumab
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.
key
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.
other protocol defined inclusion/exclusion criteria may apply.
Recruiting
390
03/02/2024
Bolt Clinical Development
Bolt Biotherapeutics, Inc.
Tucson, Arizona, United States
Tucson, Arizona, United States
Seoul, Korea, Republic of
Grand Rapids, Michigan, United States
Columbia University Medical Center
New York, New York, United States
Boston, Massachusetts, United States
© 2024 Outcomes4Me Inc. All rights reserved.