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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

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ClinicalTrials.gov Identifier: NCT04278144
Recruitment Status : Recruiting
First Posted : February 20, 2020
Last Update Posted : January 28, 2022
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Bolt Biotherapeutics, Inc.

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

Condition or disease Intervention/treatment Phase
HER2 Positive Solid Tumors Drug: BDC-1001 Drug: Nivolumab Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 390 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Multiple ascending dose and dose-expansion of BDC-1001 administered as a single agent or in combination with nivolumab.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 1/2 Study of BDC-1001 as a Single Agent and in Combination With Nivolumab in Patients With Advanced HER2-Expressing Solid Tumors
Actual Study Start Date : February 24, 2020
Estimated Primary Completion Date : January 31, 2023
Estimated Study Completion Date : July 31, 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Nivolumab

Arm Intervention/treatment
Experimental: Single agent BDC-1001
Escalating doses followed by expansion targeting HER2-expressing advanced malignancies
Drug: BDC-1001
Immune stimulating antibody conjugate (ISAC), consisting of an anti-HER2 monoclonal antibody conjugated to a TLR 7/8 dual agonist

Experimental: Combination BDC-1001 plus nivolumab
Escalating doses followed by expansion targeting HER2-expressing advanced malignancies
Drug: BDC-1001
Immune stimulating antibody conjugate (ISAC), consisting of an anti-HER2 monoclonal antibody conjugated to a TLR 7/8 dual agonist

Drug: Nivolumab
Programmed death receptor-1 (PD 1)-blocking antibody
Other Name: Opdivo




Primary Outcome Measures :
  1. Incidence of adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: 2 years ]
    Escalation period

  2. Incidence and nature of dose-limiting toxicities (DLTs) [ Time Frame: up to 21 days ]
    Escalation period

  3. Incidence of potential-immune related toxicities [ Time Frame: 2 years ]
    Escalation period

  4. Maximum tolerable dose (MTD) or a tolerated dose below MTD [ Time Frame: 2 years ]
    Escalation period

  5. Objective response rate (ORR) of confirmed complete or partial responses (CR, PR) [ Time Frame: 2 years ]
    Expansion period


Secondary Outcome Measures :
  1. PK (Cmax) of BDC-1001 [ Time Frame: 2 years ]
    Escalation and expansion periods

  2. PK (Cmin) of BDC-1001 [ Time Frame: 2 years ]
    Escalation and expansion periods

  3. PK (AUC0-t) of BDC-1001 [ Time Frame: 2 years ]
    Escalation period

  4. PK (AUC0-inf) of BDC-1001 [ Time Frame: 2 years ]
    Escalation period

  5. PK (CL) of BDC-1001 [ Time Frame: 2 years ]
    Escalation period

  6. PK (Vz) of BDC-1001 [ Time Frame: 2 years ]
    Escalation period

  7. PK (t1/2) of BDC-1001 [ Time Frame: 2 years ]
    Escalation period

  8. Objective response rate (ORR) using RECIST 1.1 [ Time Frame: 2 years ]
    Escalation period

  9. Duration of response (DOR) [ Time Frame: 2 years ]
    Escalation and expansion periods

  10. Disease control rate (DCR) of confirmed CR, PR, or stable disease (SD) lasting 4 or more weeks [ Time Frame: 2 years ]
    Escalation and expansion periods

  11. Progression Free Survival (PFS) [ Time Frame: 2 years ]
    Escalation and expansion periods

  12. Incidence of anti-BDC-1001 antibodies [ Time Frame: 2 years ]
    Escalation and expansion periods

  13. Incidence of adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: 2 years ]
    Expansion period

  14. Incidence of potential-immune related toxicities [ Time Frame: 2 years ]
    Expansion period



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04278144


Contacts
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Contact: Bolt Biotherapeutics 1-650-665-9295 info@boltbio.com

Locations
Show Show 18 study locations
Sponsors and Collaborators
Bolt Biotherapeutics, Inc.
Bristol-Myers Squibb
Investigators
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Study Director: Bolt Clinical Development Bolt Biotherapeutics
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Responsible Party: Bolt Biotherapeutics, Inc.
ClinicalTrials.gov Identifier: NCT04278144    
Other Study ID Numbers: BBI-20201001
First Posted: February 20, 2020    Key Record Dates
Last Update Posted: January 28, 2022
Last Verified: January 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bolt Biotherapeutics, Inc.:
HER2
ERBB2
Immunotherapy
Gastric Cancer
Gastroesophageal junction
Breast Cancer
Stomach Cancer
Colorectal Cancer
Gastrointestinal Cancer
Non-Small Cell Lung Cancer
Biliary Tract Cancer
Head and Neck Cancer
Urothelial Cancer
Endometrial Cancer
TLR7/8 agonist
Additional relevant MeSH terms:
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Neoplasms
Nivolumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action