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Trial record 1 of 1 for:    BBI-20201001
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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 : February 29, 2024
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Bolt Biotherapeutics, Inc.

Tracking Information
First Submitted Date  ICMJE February 12, 2020
First Posted Date  ICMJE February 20, 2020
Last Update Posted Date February 29, 2024
Actual Study Start Date  ICMJE February 24, 2020
Estimated Primary Completion Date January 31, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 5, 2021)
  • Incidence of adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: 2 years ]
    Escalation period
  • Incidence and nature of dose-limiting toxicities (DLTs) [ Time Frame: up to 21 days ]
    Escalation period
  • Incidence of potential-immune related toxicities [ Time Frame: 2 years ]
    Escalation period
  • Maximum tolerable dose (MTD) or a tolerated dose below MTD [ Time Frame: 2 years ]
    Escalation period
  • Objective response rate (ORR) of confirmed complete or partial responses (CR, PR) [ Time Frame: 2 years ]
    Expansion period
Original Primary Outcome Measures  ICMJE
 (submitted: February 18, 2020)
  • Incidence of adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: 2 years ]
    Escalation period only
  • Incidence and nature of dose-limiting toxicities (DLTs) [ Time Frame: 21 days ]
    Escalation period only
  • Incidence of potential-immune related toxicities [ Time Frame: 2 years ]
    Escalation period only
  • Maximum tolerable dose (MTD) or a tolerated dose below MTD [ Time Frame: 2 years ]
    Escalation period only
  • Overall response rate (ORR) of confirmed complete or partial responses (CR, PR) [ Time Frame: 2 years ]
    Expansion period only
  • Duration of response (DOR) of confirmed complete or partial responses (CR, PR) [ Time Frame: 2 years ]
    Expansion period only
  • Disease control rate (DCR) of confirmed responses lasting 4 or more weeks [ Time Frame: 2 years ]
    Expansion period only
  • Progression free survival (PFS) [ Time Frame: 2 years ]
    Expansion period only
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 14, 2022)
  • PK (Cmax) of BDC-1001 [ Time Frame: 2 years ]
    Escalation and expansion periods
  • PK (Cmin) of BDC-1001 [ Time Frame: 2 years ]
    Escalation and expansion periods
  • PK (AUC0-t) of BDC-1001 [ Time Frame: 2 years ]
    Escalation period
  • PK (AUC0-inf) of BDC-1001 [ Time Frame: 2 years ]
    Escalation period
  • PK (CL) of BDC-1001 [ Time Frame: 2 years ]
    Escalation period
  • PK (Vz) of BDC-1001 [ Time Frame: 2 years ]
    Escalation period
  • PK (t1/2) of BDC-1001 [ Time Frame: 2 years ]
    Escalation period
  • Objective response rate (ORR) using RECIST 1.1 [ Time Frame: 2 years ]
    Escalation period
  • Duration of response (DOR) [ Time Frame: 2 years ]
    Escalation and expansion periods
  • 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
  • Progression Free Survival (PFS) [ Time Frame: 2 years ]
    Escalation and expansion periods
  • Incidence of anti-BDC-1001 antibodies [ Time Frame: 2 years ]
    Escalation and expansion periods
  • Incidence of adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: 2 years ]
    Expansion period
  • Incidence of potential-immune related toxicities [ Time Frame: 2 years ]
    Expansion period
Original Secondary Outcome Measures  ICMJE
 (submitted: February 18, 2020)
  • PK (Cmax) of BDC-1001 as monotherapy and in combination with pembrolizumab [ Time Frame: 2 years ]
    Escalation and expansion periods
  • PK (Cmin) of BDC-1001 as monotherapy and in combination with pembrolizumab [ Time Frame: 2 years ]
    Escalation and expansion periods
  • PK (AUC) of BDC-1001 as monotherapy and in combination with pembrolizumab [ Time Frame: 2 years ]
    Escalation and expansion periods
  • Overall response rate (ORR) of confirmed complete or partial responses (CR, PR) [ Time Frame: 2 years ]
    Escalation period only
  • Duration of response (DOR) [ Time Frame: 2 years ]
    Escalation period only
  • Disease control rate (DCR) of confirmed responses lasting 4 or more weeks [ Time Frame: 2 years ]
    Escalation period only
  • Incidence of anti-BDC-1001 antibodies and neutralizing antibodies to BDC-1001 or pembrolizumab [ Time Frame: 2 years ]
    Escalation and expansion periods
  • Incidence of adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: 2 years ]
    Expansion period only
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A First-in-human Study Using BDC-1001 as a Single Agent and in Combination With Nivolumab in Advanced HER2-Expressing Solid Tumors
Official Title  ICMJE Phase 1/2 Study of BDC-1001 as a Single Agent and in Combination With Nivolumab in Patients With Advanced HER2-Expressing Solid Tumors
Brief 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE 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
Condition  ICMJE
  • HER2-positive Solid Tumors
  • HER2-positive Breast Cancer
  • HER2-positive Colorectal Cancer
  • HER2-positive Gastroesophageal Cancer
  • HER2-positive Endometrial Cancer
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: Single agent BDC-1001
    Escalating doses followed by expansion targeting HER2-expressing advanced malignancies
    Intervention: Drug: BDC-1001
  • Experimental: Combination BDC-1001 plus nivolumab
    Escalating doses followed by expansion targeting HER2-expressing advanced malignancies
    Interventions:
    • Drug: BDC-1001
    • Drug: Nivolumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 18, 2020)		 390
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 31, 2026
Estimated Primary Completion Date January 31, 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Bolt Biotherapeutics +1 650 434 8640 clinicaltrials@boltbio.com
Listed Location Countries  ICMJE France,   Italy,   Korea, Republic of,   Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04278144
Other Study ID Numbers  ICMJE BBI-20201001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Bolt Biotherapeutics, Inc.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Bolt Biotherapeutics, Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Bristol-Myers Squibb
Investigators  ICMJE
Study Director: Bolt Clinical Development Bolt Biotherapeutics
PRS Account Bolt Biotherapeutics, Inc.
Verification Date February 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP