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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04278144
Other study ID # BBI-20201001
Secondary ID
Status Active, not recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date February 24, 2020
Est. completion date October 31, 2026

Study information

Verified date May 2024
Source Bolt Biotherapeutics, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A first-in-human study using BDC-1001 as a single agent and in combination with nivolumab 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 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 390
Est. completion date October 31, 2026
Est. primary completion date January 31, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

Drug:
BDC-1001
Immune stimulating antibody conjugate (ISAC), consisting of an anti-HER2 monoclonal antibody conjugated to a TLR 7/8 dual agonist
Nivolumab
Programmed death receptor-1 (PD 1)-blocking antibody

Locations

Country Name City State
France Institut Bergonie Bordeaux
France Institut Paoli Calmettes Marseille
France Hopital Pitie-Salpetriere Paris
France Centre Eugene Marquis Rennes
France Institut Gustave Roussy Villejuif
Italy Instituto Clinico Humanitas Milan Lombardia
Italy Istituto Nazionale Tumori IRCCS Fondazione G. Pascale Napoli Campania
Korea, Republic of Seoul National University Bundang Hospital Seongnam-si Gyeonggi-do
Korea, Republic of Asan Medical Center Seoul Songpa-gu
Korea, Republic of Samsung Medical Center Seoul Gangnam-gu
Spain Hospital del Mar Barcelona Cataluna
Spain Hospital Universitario Vall d'Hebron Barcelona Cataluna
Spain Institut Catala D'Oncologia Barcelona
Spain Hospital Universitario 12 de Octubre Madrid
Spain Hospital Universitario Ramón y Cajal Madrid
United States Dana-Farber Cancer Institute Boston Massachusetts
United States Levine Cancer Institute Charlotte North Carolina
United States The University of Chicago Medical Center Chicago Illinois
United States Virginia Cancer Specialists Fairfax Virginia
United States START Midwest Grand Rapids Michigan
United States The University of Texas MD Anderson Cancer Center Houston Texas
United States Memorial Sloan-Kettering Cancer Center New York New York
United States Stephenson Cancer Center Oklahoma City Oklahoma
United States Stanford University Palo Alto California
United States South Texas Accelerated Research Therapeutics San Antonio Texas
United States Georgetown University Medical Center Washington District of Columbia

Sponsors (2)

Lead Sponsor Collaborator
Bolt Biotherapeutics, Inc. Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  France,  Italy,  Korea, Republic of,  Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of adverse events (AEs) and serious adverse events (SAEs) Escalation period 2 years
Primary Incidence and nature of dose-limiting toxicities (DLTs) Escalation period up to 21 days
Primary Incidence of potential-immune related toxicities Escalation period 2 years
Primary Maximum tolerable dose (MTD) or a tolerated dose below MTD Escalation period 2 years
Primary Objective response rate (ORR) of confirmed complete or partial responses (CR, PR) Expansion period 2 years
Secondary PK (Cmax) of BDC-1001 Escalation and expansion periods 2 years
Secondary PK (Cmin) of BDC-1001 Escalation and expansion periods 2 years
Secondary PK (AUC0-t) of BDC-1001 Escalation period 2 years
Secondary PK (AUC0-inf) of BDC-1001 Escalation period 2 years
Secondary PK (CL) of BDC-1001 Escalation period 2 years
Secondary PK (Vz) of BDC-1001 Escalation period 2 years
Secondary PK (t1/2) of BDC-1001 Escalation period 2 years
Secondary Objective response rate (ORR) using RECIST 1.1 Escalation period 2 years
Secondary Duration of response (DOR) Escalation and expansion periods 2 years
Secondary Disease control rate (DCR) of confirmed CR, PR, or stable disease (SD) lasting 4 or more weeks Escalation and expansion periods 2 years
Secondary Progression Free Survival (PFS) Escalation and expansion periods 2 years
Secondary Incidence of anti-BDC-1001 antibodies Escalation and expansion periods 2 years
Secondary Incidence of adverse events (AEs) and serious adverse events (SAEs) Expansion period 2 years
Secondary Incidence of potential-immune related toxicities Expansion period 2 years
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