A First-in-human Study Using BDC-1001 as a Single Agent and in Combination With Nivolumab in Adva… (NCT04278144) | Clinical Trial Compass
TerminatedPhase 1/2
A First-in-human Study Using BDC-1001 as a Single Agent and in Combination With Nivolumab in Advanced HER2-Expressing Solid Tumors
Stopped: Sponsor Decision
United States, France, South Korea175 participantsStarted 2020-02-24
Plain-language summary
A first-in-human study using BDC-1001 as a single agent and in combination with nivolumab in HER2 expressing advanced malignancies
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of adverse events (AEs) and serious adverse events (SAEs)
Timeframe: 2 years
2
Incidence and nature of dose-limiting toxicities (DLTs)
Timeframe: up to 21 days
3
Incidence of potential-immune related toxicities
Timeframe: 2 years
4
Maximum tolerable dose (MTD) or a tolerated dose below MTD
Timeframe: 2 years
5
Objective response rate (ORR) of confirmed complete or partial responses (CR, PR)