Trials / Terminated
TerminatedNCT04278144
A First-in-human Study Using BDC-1001 as a Single Agent and in Combination With Nivolumab in Advanced HER2-Expressing Solid Tumors
Phase 1/2 Study of BDC-1001 as a Single Agent and in Combination With Nivolumab in Patients With Advanced HER2-Expressing Solid Tumors
- Status
- Terminated
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 175 (actual)
- Sponsor
- Bolt Biotherapeutics, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
A first-in-human study using BDC-1001 as a single agent and in combination with nivolumab 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 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. Bolt amended the protocol to transition any subjects still receiving BDC-1001 to continue receiving BDC-1001 in the Maintenance Phase. Subjects remaining on BDC-1001 will continue to receive BDC-1001 until a criterion for discontinuation has been met.
Conditions
- HER2-positive Solid Tumors
- HER2-positive Breast Cancer
- HER2-positive Colorectal Cancer
- HER2-positive Gastroesophageal Cancer
- HER2-positive Endometrial Cancer
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | BDC-1001 | Immune stimulating antibody conjugate (ISAC), consisting of an anti-HER2 monoclonal antibody conjugated to a TLR 7/8 dual agonist |
| DRUG | Nivolumab | Programmed death receptor-1 (PD 1)-blocking antibody |
Timeline
- Start date
- 2020-02-24
- Primary completion
- 2024-12-10
- Completion
- 2025-02-14
- First posted
- 2020-02-20
- Last updated
- 2025-09-15
Locations
21 sites across 4 countries: United States, France, South Korea, Spain
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04278144. Inclusion in this directory is not an endorsement.