A First-in-human Study Using BDC-1001 as a Single Agent and in Combination With Nivolumab in Advanced HER2-Expressing Solid Tumors
Purpose
A first-in-human study using BDC-1001 as a single agent and in combination with nivolumab in HER2 expressing advanced malignancies
Conditions
- HER2-positive Solid Tumors
- HER2-positive Breast Cancer
- HER2-positive Colorectal Cancer
- HER2-positive Gastroesophageal Cancer
- HER2-positive Endometrial Cancer
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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.
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.
Study Design
- Phase
- Phase 1/Phase 2
- Study Type
- Interventional
- 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.
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Experimental Single agent BDC-1001 |
Escalating doses followed by expansion targeting HER2-expressing advanced malignancies |
|
Experimental Combination BDC-1001 plus nivolumab |
Escalating doses followed by expansion targeting HER2-expressing advanced malignancies |
|
Recruiting Locations
Washington, District of Columbia 20007
More Details
- Status
- Recruiting
- Sponsor
- Bolt Biotherapeutics, Inc.
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.