Study of BDC-3042 as Single Agent and in Combination With Cemiplimab in Patients With Advanced Ma… (NCT06052852) | Clinical Trial Compass
TerminatedPhase 1
Study of BDC-3042 as Single Agent and in Combination With Cemiplimab in Patients With Advanced Malignancies
Stopped: Sponsor decision
United States17 participantsStarted 2023-10-11
Plain-language summary
A first-in-human study using BDC-3042 as a single agent and in combination with cemiplimab in patients with 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.
Inclusion criteria
. Able to understand and sign the informed consent form
. Age 18 years or older at the time of informed consent
. Has disease that is measurable by Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1
. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
. Subjects enrolled in Part 1 and Part 2 dose escalation cohorts must have:
. Subjects enrolled in Part 3 and Part 4 dose expansion cohorts must have histologically/cytologically confirmed metastatic or unresectable disease with tumor progression after standard therapy.
. Adequate organ function defined as follows:
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 treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) graded according to CTCAE v5.0
Timeframe: 2 years
2
Incidence and nature of AEs considered by the Investigator or Sponsor to be clinically relevant, attributable to study treatment, and meeting dose-limiting toxicity (DLT) criteria
. Hematology: i. Absolute neutrophil count ≥ 1500 cells/mm3; ii. Platelet count ≥ 75,000 cells/mm3 (without transfusion for 14 days); iii. Hemoglobin ≥ 9 g/dL (and without transfusion within 14 days)
Exclusion criteria
. Active systemic yeast infection within 4 weeks before study treatment
. Prior hospitalization for asthma during past year
. Central nervous system metastases except for disease that is asymptomatic, clinically stable, and has not required steroids for at least 28 days before starting study treatment
. Cardiac disease including:
. Congestive heart failure New York Heart Association classes II-IV
. QTcF prolongation \> 480 milliseconds (ms) based on a 12-lead electrocardiogram (ECG)
. Serious or uncontrolled cardiac arrhythmia within 6 months before starting study treatment
. Myocardial infarction, unstable angina pectoris, or coronary angioplasty, stenting, or surgery within 6 months before starting study treatment