Clinical trial · Interventional
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
NCT04278144CI-TRIAL-00095160terminatedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Sponsor Decision
Summary
Brief summary (as posted)
A first-in-human study using BDC-1001 as a single agent and in combination with nivolumab in HER2 expressing advanced malignancies
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| HER2-positive Breast Cancer | HER2-Positive Breast Carcinoma | ALIAS | 0.90 |
| HER2-positive Colorectal Cancer | HER2-Positive Colorectal Carcinoma | ALIAS | 0.90 |
| HER2-positive Endometrial Cancer | — | UNRESOLVED | — |
| HER2-positive Gastroesophageal Cancer | — | UNRESOLVED | — |
| HER2-positive Solid Tumors | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BDC-1001 | Drug | — | UNRESOLVED |
| Nivolumab | Drug | Nivolumab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Single agent BDC-1001
- description
- Escalating doses followed by expansion targeting HER2-expressing advanced malignancies
- interventionNames
- Drug: BDC-1001
- type
- EXPERIMENTAL
- label
- Combination BDC-1001 plus nivolumab
- description
- Escalating doses followed by expansion targeting HER2-expressing advanced malignancies
- interventionNames
- Drug: BDC-1001
- Drug: Nivolumab
Primary outcomes (5)
- measure
- Incidence of adverse events (AEs) and serious adverse events (SAEs)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.