Clinical Trials /

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

NCT04278144

Description:

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

Related Conditions:
  • Malignant Solid Tumor
Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: A First-in-human Study Using BDC-1001 in Advanced HER2-Expressing Solid Tumors
  • 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

Clinical Trial IDs

  • ORG STUDY ID: BBI-20201001
  • NCT ID: NCT04278144

Conditions

  • Neoplasm, Metastatic
  • Neoplasm, Breast
  • Neoplasm, Gastric

Interventions

DrugSynonymsArms
BDC-1001Combination BDC-1001 plus pembrolizumab
PembrolizumabKeytrudaCombination BDC-1001 plus pembrolizumab

Purpose

A first-in-human study using BDC-1001 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 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.
    

Trial Arms

NameTypeDescriptionInterventions
Single agent BDC-1001ExperimentalEscalating doses followed by expansion targeting breast and non-breast HER2 advanced malignancies
  • BDC-1001
Combination BDC-1001 plus pembrolizumabExperimentalEscalating doses followed by expansion targeting breast and non-breast HER2 advanced malignancies
  • BDC-1001
  • Pembrolizumab

Eligibility 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.

          -  Untreated central nervous system (CNS), epidural tumor or metastasis, or brain
             metastasis.

        Other protocol defined inclusion/exclusion criteria may apply.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Incidence of adverse events (AEs) and serious adverse events (SAEs)
Time Frame:2 years
Safety Issue:
Description:Escalation period only

Secondary Outcome Measures

Measure:PK (Cmax) of BDC-1001 as monotherapy and in combination with pembrolizumab
Time Frame:2 years
Safety Issue:
Description:Escalation and expansion periods
Measure:PK (Cmin) of BDC-1001 as monotherapy and in combination with pembrolizumab
Time Frame:2 years
Safety Issue:
Description:Escalation and expansion periods
Measure:PK (AUC) of BDC-1001 as monotherapy and in combination with pembrolizumab
Time Frame:2 years
Safety Issue:
Description:Escalation and expansion periods
Measure:PK (CL) of BDC-1001 as monotherapy and in combination with pembrolizumab
Time Frame:2 years
Safety Issue:
Description:Escalation and expansion periods
Measure:PK (Vz) of BDC-1001 as monotherapy and in combination with pembrolizumab
Time Frame:2 years
Safety Issue:
Description:Escalation and expansion periods
Measure:PK (t1/2) of BDC-1001 as monotherapy and in combination with pembrolizumab
Time Frame:2 years
Safety Issue:
Description:Escalation and expansion periods
Measure:Overall response rate (ORR) using RECIST 1.1 and iRECIST
Time Frame:2 years
Safety Issue:
Description:Escalation period only
Measure:Duration of response (DOR)
Time Frame:2 years
Safety Issue:
Description:Escalation and expansion periods
Measure:Disease control rate (DCR) of confirmed CR, PR, or stable disease (SD) lasting 4 or more weeks
Time Frame:2 years
Safety Issue:
Description:Escalation and expansion periods
Measure:Progression Free Survival (PFS)
Time Frame:2 years
Safety Issue:
Description:Escalation and expansion periods
Measure:Overall Survival (OS)
Time Frame:2 years
Safety Issue:
Description:Escalation and expansion periods
Measure:Incidence of anti-BDC-1001 antibodies and neutralizing antibodies to BDC-1001 or pembrolizumab
Time Frame:2 years
Safety Issue:
Description:Escalation and expansion periods
Measure:Incidence of adverse events (AEs) and serious adverse events (SAEs)
Time Frame:2 years
Safety Issue:
Description:Expansion period only

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Bolt Biotherapeutics, Inc.

Last Updated

February 8, 2021