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The trial is taking place at:
A

Asan Medical Center | Clinical Trial Center

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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

B

Bolt Biotherapeutics

Status and phase

Active, not recruiting
Phase 2
Phase 1

Conditions

HER2-positive Endometrial Cancer
HER2-positive Colorectal Cancer
HER2-positive Solid Tumors
HER2-positive Breast Cancer
HER2-positive Gastroesophageal Cancer

Treatments

Drug: BDC-1001
Drug: Nivolumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT04278144
BBI-20201001

Details and patient eligibility

About

A first-in-human study using BDC-1001 as a single agent and in combination with nivolumab in HER2 expressing advanced malignancies

Full 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.

Enrollment

390 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

390 participants in 2 patient groups

Single agent BDC-1001
Experimental group
Description:
Escalating doses followed by expansion targeting HER2-expressing advanced malignancies
Treatment:
Drug: BDC-1001
Combination BDC-1001 plus nivolumab
Experimental group
Description:
Escalating doses followed by expansion targeting HER2-expressing advanced malignancies
Treatment:
Drug: Nivolumab
Drug: BDC-1001

Trial contacts and locations

26

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Central trial contact

Bolt Biotherapeutics

Data sourced from clinicaltrials.gov

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