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Trial record 1 of 1 for:    BBI-20201001
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A First-in-human Study Using BDC-1001 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 : May 27, 2021
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
HER2 Positive Solid Tumors Drug: BDC-1001 Drug: Pembrolizumab 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 pembrolizumab 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 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: Parallel Assignment
Intervention Model Description: Multiple ascending dose and dose-expansion of BDC-1001 administered as a single agent or in combination with pembrolizumab.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 1/2 Study of BDC-1001 as a Single Agent and in Combination With Pembrolizumab 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


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: up to 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


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

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

  6. PK (t1/2) of BDC-1001 as monotherapy and in combination with pembrolizumab [ Time Frame: 2 years ]
    Escalation and expansion periods

  7. Overall response rate (ORR) using RECIST 1.1 and iRECIST [ Time Frame: 2 years ]
    Escalation period only

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

  9. 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

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

  11. Overall Survival (OS) [ Time Frame: 2 years ]
    Escalation and expansion periods

  12. Incidence of anti-BDC-1001 antibodies and neutralizing antibodies to BDC-1001 or pembrolizumab [ 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 only



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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
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United States, California
Stanford University Recruiting
Palo Alto, California, United States, 94304
Contact: Grace A Castaneda    650-721-4076    annabelc@stanford.edu   
United States, District of Columbia
Georgetown University Medical Center Recruiting
Washington, District of Columbia, United States, 20007
Contact: Stephanie Wagner, RN    202-687-9782    sw1095@georgetown.edu   
United States, Massachusetts
Dana-Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: DFCI Clinical Trials Hotline    877-338-7425      
United States, Michigan
Henry Ford Hospital Recruiting
Detroit, Michigan, United States, 48202
Contact: Karie Gignac, RN    313-695-9808    Kgignac1@hfhs.org   
START Midwest Recruiting
Grand Rapids, Michigan, United States, 49546
Contact: Kathy Estkowski       kathy.estkowski@startmidwest.com   
United States, New York
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact    212-342-5162    cancerclinicaltrials@cumc.columbia.edu   
Memorial Sloan-Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Bob Li, MD    646-888-4201      
United States, Oklahoma
Stephenson Cancer Center Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Phase I Referrals       phaseI-referrals@ouhsc.edu   
United States, Texas
The University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Ecaterina I Dumbrava, MD    713-563-1930    EEIleana@mdanderson.org   
South Texas Accelerated Research Therapeutics Recruiting
San Antonio, Texas, United States, 78229
Contact: Isabel Jimenez, RN    210-593-5265    isabel.jimenez@startsa.com   
United States, Virginia
Virginia Cancer Specialists Recruiting
Fairfax, Virginia, United States, 22031
Contact: Alexander Spira, MD, PhD, FACP    703-280-5390      
Korea, Republic of
Samsung Medical Center Recruiting
Seoul, Gangnam-gu, Korea, Republic of, 06351
Contact: Jeeyun Lee, MD    +82-2-3410-1754    jyunlee@skku.edu   
Seoul National University Bundang Hospital Recruiting
Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
Contact: Keun-Wook Lee, MD, PhD    +82-31-787-7037    hmodoctor@snubh.org   
Asan Medical Center Recruiting
Seoul, Songpa-gu, Korea, Republic of, 05505
Contact: Yoon-Koo Kang, MD, PhD    +82-2-3010-3230    ykkang@amc.seoul.kr   
Sponsors and Collaborators
Bolt Biotherapeutics, Inc.
Investigators
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Study Director: Amreen Husain, MD 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 27, 2021
Last Verified: May 2021

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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
Pembrolizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents