Rina-S
DrugIntravenous (IV) infusion.
Other names: Rinatabart Sesutecan, PRO1184, GEN1184
NCT Number: NCT07288177
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 2
St Andrews Medical Centre, Adelaide, Australia
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Key Inclusion Criteria:
Key Exclusion Criteria (all study cohorts):
Note: Other protocol-defined Inclusion and Exclusion criteria may apply.
Intravenous (IV) infusion.
Other names: Rinatabart Sesutecan, PRO1184, GEN1184
Time frame: Approximately 3 years
Time frame: Approximately 4 years
Time frame: Approximately 4 years
Time frame: Approximately 4 years
Time frame: Approximately 4 years
Time frame: Approximately 12 months
Time frame: Approximately 12 months
Time frame: Approximately 12 months
Time frame: Approximately 4 years
Contact information is provided by the study sponsor or research team.
Genmab
Industry
A Phase 2, Open-label, Multicohort Study of Rinatabart Sesutecan (Rina-S) in Participants With Non-Small Cell Lung Cancer
Acronym: RAINFOL-05
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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