Clinical Trials /

A First-in-human Study Using BDC-1001 in Advanced and 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

Trial Eligibility

Document

Title

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

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 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.
    

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.

          -  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.
      
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:Overall response rate (ORR) of confirmed complete or partial responses (CR, PR)
Time Frame:2 years
Safety Issue:
Description:Escalation period only
Measure:Duration of response (DOR)
Time Frame:2 years
Safety Issue:
Description:Escalation period only
Measure:Disease control rate (DCR) of confirmed responses lasting 4 or more weeks
Time Frame:2 years
Safety Issue:
Description:Escalation period only
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
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Bolt Biotherapeutics, Inc.

Last Updated

February 24, 2020