A First-in-human Study Using BDC-1001 as a Single Agent and in Combination With Nivolumab in Advanced HER2-Expressing Solid Tumors
- Interventional
- Recruiting
- NCT04278144
Contact Information
Phase 1/2 Study of BDC-1001 as a Single Agent and in Combination With Nivolumab in Patients With Advanced HER2-Expressing Solid Tumors
A first-in-human study using BDC-1001 as a single agent and in combination with nivolumab in HER2 expressing advanced malignancies
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.
Gender
All
Age Group
18 Years and up
Accepting Healthy Volunteers?
No
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.
- 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.