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

TERMINATEDPHASE1/PHASE2

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

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

NCT04278144•Bolt Biotherapeutics, Inc.

View on ClinicalTrials.gov

Summary

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

Detailed 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. Bolt amended the protocol to transition any subjects still receiving BDC-1001 to continue receiving BDC-1001 in the Maintenance Phase. Subjects remaining on BDC-1001 will continue to receive BDC-1001 until a criterion for discontinuation has been met.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.
•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.

Locations (21)

Stanford University

Palo Alto, California, United States

Georgetown University Medical Center

Washington D.C., District of Columbia, United States

The University of Chicago Medical Center

Chicago, Illinois, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

START Midwest

Grand Rapids, Michigan, United States

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Levine Cancer Institute

Charlotte, North Carolina, United States

Stephenson Cancer Center

Oklahoma City, Oklahoma, United States

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States

South Texas Accelerated Research Therapeutics

San Antonio, Texas, United States

Key Dates

Start Date

February 24, 2020

Primary Completion Date

December 10, 2024

Completion Date

February 14, 2025

Last Updated

September 15, 2025

Enrollment

175

ACTUAL participants

Conditions

HER2-positive Solid TumorsHER2-positive Breast CancerHER2-positive Colorectal CancerHER2-positive Gastroesophageal CancerHER2-positive Endometrial Cancer

Interventions

BDC-1001

DRUG

Nivolumab

DRUG

Trial of Pre-operative Neratinib and Endocrine Therapy With Trastuzumab in ER-Positive, HER-2 Positive Breast Cancers

NCT04886531

Breast CancerHER2-positive Breast Cancer+2 more

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RECRUITINGPHASE1/PHASE2

The Evaluation of PC14586 in Patients With Advanced Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)

NCT04585750

Advanced Solid TumorAdvanced Malignant Neoplasm+28 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 15, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Trial of Pre-operative Neratinib and Endocrine Therapy With Trastuzumab in ER-Positive, HER-2 Positive Breast Cancers

The Evaluation of PC14586 in Patients With Advanced Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)

A Phase 2 Neoadjuvant Study of Zanidatamab in Combination With Chemotherapy in Participants With HER2-positive Breast Cancer

A Study of Surgery and Radiotherapy in People With Breast Cancer

Assessing the Efficacy and Safety of Anti-HER2 Therapy in Nigerian Women With HER2+ Breast Cancer Before and After Surgery

Radiation Therapy Followed by Intrathecal Trastuzumab/Pertuzumab in HER2+ Breast Leptomeningeal Disease