Safety and Clinical Activity of Nivatrotamab in Relapsed/Recurrent Metastatic Small-cell Lung Cancer
Trial Summary
Will I have to stop taking my current medications?
The trial requires that you stop taking any immunosuppressive medications and steroids at least 10 days before starting the study drug. If you are on any other investigational therapy, you must stop it 3 weeks before the trial begins.
What safety data exists for Nivatrotamab (also known as Nivolumab)?
Nivolumab, a treatment for various cancers, has been studied in many clinical trials. Common side effects include fatigue, rash, itching, diarrhea, nausea, and weakness. Serious side effects, though rare, can include low phosphate levels and low white blood cell counts. There is also a small risk of immune-related issues like colitis (inflammation of the colon).12345
What is the purpose of this trial?
This trial tests nivatrotamab, a drug that helps the immune system attack small-cell lung cancer. It targets specific proteins on cancer and immune cells to help the body fight the cancer. The study aims to find the safest dose and see how well it works in patients.
Eligibility Criteria
Inclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Dose Escalation
Phase 1 dose escalation to determine the maximum tolerated dose (MTD) and the recommended phase 2 dose (RP2D) using a modified Bayesian Optimal Interval Design (mBOIN). Dose-limiting toxicities (DLTs) are collected and assessed.
Dose Expansion
Phase 2 dose expansion to assess long-term safety, tolerability, and clinical activity of nivatrotamab at the MTD/RP2D. Patients are stratified by platinum sensitivity.
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Nivatrotamab
Find a Clinic Near You
Who Is Running the Clinical Trial?
Y-mAbs Therapeutics
Lead Sponsor