A Phase 2, Open-label, Multicohort Study of Rinatabart Sesutecan (Rina-S) in Participants With Non-Small Cell Lung Cancer
Summary
This Phase 2 study will be conducted in different countries around the world with up to about 240 participants. The purpose of this study is to evaluate how well Rina-S works against lung cancer. The treatment in this study is Rina-S monotherapy (by itself). All participants will receive active drug; no one will be given placebo. The treatment duration will be different for every participant, but an average of 12 months is expected. Participants will be asked to attend 1 to 5 visits at the study clinic for each cycle (duration of cycle is 3 weeks). If a participant's cancer stays the same or gets better, and there are not any serious problems, participants can keep getting study treatment for as long as the study is open. Participation in the study will require visits to the study site(s). During site visits, there will be various tests (such as blood draws) and procedures (such as recording of heart activity, imaging/X-rays) to monitor whether the study treatment is safe and effective.
Detailed description
This is a Phase 2, open-label, multicenter, multi-cohort trial to evaluate the safety, efficacy, pharmacokinetics (PK), and pharmacodynamics of Rina-S as monotherapy in participants with locally advanced or metastatic non-small cell lung cancer (NSCLC), with or without select genomic aberrations.
Arms & interventions
- DrugRina-S
Intravenous (IV) infusion.
Outcome measures
Primary
Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as Assessed by Investigator
Time frame: Approximately 3 years
Secondary
Duration of Response (DOR) per RECIST v1.1 as Assessed by Investigator
Time frame: Approximately 4 years
Disease Control Rate (DCR) per RECIST v1.1 as Assessed by Investigator
Time frame: Approximately 4 years
Progression-free Survival (PFS)
Time frame: Approximately 4 years
Overall Survival (OS)
Time frame: Approximately 4 years
Maximum (Peak) Observed Serum Drug Concentration (Cmax) of Rina-S Related Analytes
Time frame: Approximately 12 months
Time to Reach Maximum (Peak) Serum Drug Concentration (Tmax) of Rina-S Related Analytes
Time frame: Approximately 12 months
Number of Participants with Antidrug Antibodies (ADAs)
Time frame: Approximately 12 months
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Time frame: Approximately 4 years
Eligibility criteria
Study locations (8)
Compassionate Cancer Care Center
Fountain Valley, California, 92708
Providence Medical Foundation (St. Joseph Heritage Healthcare)
Santa Rosa, California, 95403
Nebraska Hematology-Oncology
Lincoln, Nebraska, 68506
Astera Cancer Care
East Brunswick, New Jersey, 08816
ONE Onc: New York Oncology Hematology
Albany, New York, 12206
Montefiore Medical Park
The Bronx, New York, 10461
Tennessee Oncology - Nashville St. Thomas Midtown Clinic
Nashville, Tennessee, 37203
Virginia Cancer Specialists
Fairfax, Virginia, 22031