Breast Cancer Clinical Trial

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

Summary

A first-in-human study using BDC-1001 as a single agent and in combination with nivolumab in HER2 expressing advanced malignancies

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Full 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 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.

View Eligibility Criteria

Eligibility Criteria

Key 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.

Key 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.
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.

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

390

Study ID:

NCT04278144

Recruitment Status:

Recruiting

Sponsor:

Bolt Biotherapeutics, Inc.

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There are 16 Locations for this study

See Locations Near You

Stanford University
Palo Alto California, 94304, United States More Info
Grace A Castaneda
Contact
650-721-4076
[email protected]
Georgetown University Medical Center
Washington District of Columbia, 20007, United States More Info
Stephanie Wagner, RN
Contact
202-687-9782
[email protected]
The University of Chicago Medical Center
Chicago Illinois, 60637, United States More Info
Clinical Trials Intake
Contact
855-702-8222
[email protected]
Dana-Farber Cancer Institute
Boston Massachusetts, 02215, United States More Info
DFCI Clinical Trials Hotline
Contact
877-338-7425
Henry Ford Hospital
Detroit Michigan, 48202, United States More Info
Karie Gignac, RN
Contact
313-695-9808
[email protected]
START Midwest
Grand Rapids Michigan, 49546, United States More Info
Katie L Robinson, BSN, RN, OCN
Contact
[email protected]
Columbia University Medical Center
New York New York, 10032, United States More Info
Memorial Sloan-Kettering Cancer Center
New York New York, 10065, United States More Info
Bob Li, MD
Contact
646-888-4201
Levine Cancer Institute
Charlotte North Carolina, 28204, United States More Info
Carrie Chiluck, BSN, RN, OCN
Contact
[email protected]
Stephenson Cancer Center
Oklahoma City Oklahoma, 73104, United States More Info
Phase I Referrals
Contact
[email protected]
The University of Texas MD Anderson Cancer Center
Houston Texas, 77030, United States More Info
Ecaterina I Dumbrava, MD
Contact
713-563-1930
[email protected]
South Texas Accelerated Research Therapeutics
San Antonio Texas, 78229, United States More Info
Isabel Jimenez, RN
Contact
210-593-5265
[email protected]
Virginia Cancer Specialists
Fairfax Virginia, 22031, United States More Info
Alexander Spira, MD, PhD, FACP
Contact
703-280-5390
Samsung Medical Center
Seoul Gangnam-gu, 06351, Korea, Republic of More Info
Jeeyun Lee, MD
Contact
+82-2-3410-1754
[email protected]
Seoul National University Bundang Hospital
Seongnam-si Gyeonggi-do, 13620, Korea, Republic of More Info
Keun-Wook Lee, MD, PhD
Contact
+82-31-787-7037
[email protected]
Asan Medical Center
Seoul Songpa-gu, 05505, Korea, Republic of More Info
Yoon-Koo Kang, MD, PhD
Contact
+82-2-3010-3230
[email protected]

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

390

Study ID:

NCT04278144

Recruitment Status:

Recruiting

Sponsor:


Bolt Biotherapeutics, Inc.

How clear is this clinincal trial information?

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