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A First-in-human Study Using BDC-1001 in Advanced and HER2-Expressing Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04278144
Recruitment Status : Recruiting
First Posted : February 20, 2020
Last Update Posted : May 18, 2020
Sponsor:
Information provided by (Responsible Party):
Bolt Biotherapeutics, Inc.

Brief Summary:
A first-in-human study using BDC-1001 in HER2 expressing advanced malignancies

Condition or disease Intervention/treatment Phase
Neoplasm, Metastatic Neoplasm, Breast Neoplasm, Gastric Drug: BDC-1001 Drug: Pembrolizumab Phase 1

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 for Part 3 and Phase 2 (RP2D). 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 pembrolizumab to determine the maximum tolerated dose (MTD) recommended for Part 4 and Phase 2 (RP2D). In Part 4, the selected dose will be administered in combination with pembrolizumab to patients with selected advanced malignancies.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 390 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 1 Study of BDC-1001 as a Single Agent and in Combination With Pembrolizumab in Patients With Advanced and 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


Arm Intervention/treatment
Experimental: Single agent BDC-1001
Escalating doses followed by expansion targeting breast and non-breast HER2 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 pembrolizumab
Escalating doses followed by expansion targeting breast and non-breast HER2 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: Pembrolizumab
Programmed death receptor-1 (PD 1)-blocking antibody
Other Name: Keytruda




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

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

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

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

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

  6. Duration of response (DOR) of confirmed complete or partial responses (CR, PR) [ Time Frame: 2 years ]
    Expansion period only

  7. Disease control rate (DCR) of confirmed responses lasting 4 or more weeks [ Time Frame: 2 years ]
    Expansion period only

  8. Progression free survival (PFS) [ Time Frame: 2 years ]
    Expansion period only


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

  2. PK (Cmin) of BDC-1001 as monotherapy and in combination with pembrolizumab [ Time Frame: 2 years ]
    Escalation and expansion periods

  3. PK (AUC) of BDC-1001 as monotherapy and in combination with pembrolizumab [ Time Frame: 2 years ]
    Escalation and expansion periods

  4. Overall response rate (ORR) of confirmed complete or partial responses (CR, PR) [ Time Frame: 2 years ]
    Escalation period only

  5. Duration of response (DOR) [ Time Frame: 2 years ]
    Escalation period only

  6. Disease control rate (DCR) of confirmed responses lasting 4 or more weeks [ Time Frame: 2 years ]
    Escalation period only

  7. Incidence of anti-BDC-1001 antibodies and neutralizing antibodies to BDC-1001 or pembrolizumab [ Time Frame: 2 years ]
    Escalation and expansion periods

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



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.
  • For the combination portion of the study, previous treatment with an anti-PD1 or anti- PD-L1 therapy.
  • Impaired cardiac function or history of clinically significant cardiac disease
  • Human Immunodeficiency virus (HIV) infection, active hepatitis B infection, or hepatitis C 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
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United States, Michigan
Bolt Investigative Site Recruiting
Grand Rapids, Michigan, United States, 49546
United States, Texas
Bolt Investigative Site Recruiting
Houston, Texas, United States, 77030
Bolt Investigative Site Recruiting
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Bolt Biotherapeutics, Inc.
Investigators
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Study Director: Robert Sikorski, MD, PhD 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: May 18, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Stomach Neoplasms
Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Pembrolizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents