Description:
A first-in-human study using BDC-1001 in HER2 expressing advanced malignancies
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
- HER2 Positive Solid Tumors
Interventions
| Drug | Synonyms | Arms |
|---|
| BDC-1001 | | Combination BDC-1001 plus pembrolizumab |
| Pembrolizumab | Keytruda | Combination 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
| Name | Type | Description | Interventions |
|---|
| Single agent BDC-1001 | Experimental | Escalating doses followed by expansion targeting breast and non-breast HER2 advanced malignancies | |
| Combination BDC-1001 plus pembrolizumab | Experimental | Escalating doses followed by expansion targeting breast and non-breast HER2 advanced malignancies | |
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.
- 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.
| 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. |
Trial Keywords
- 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
Last Updated
August 25, 2021
