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Recruiting Phase 2 2025-522107-18-00

A Phase 2, Open-label, Multicohort, Study of Rinatabart Sesutecan (Rina-S) in Participants with Non-Small Cell Lung Cancer

Phase 2 – studying effectiveness and dosage
Conditions: Locally advanced or metastatic Non-Small Cell Lung Cancer

Sponsor: Genmab A/S

trial.available_in: БГ
Overview
Trial status: Authorised 1.Duration of Response (DOR) per RECIST v1.1 as Assessed by Investigator [Time Frame: Approximately 4 years], 2.Disease Control Rate (DCR) per RECIST v1.1 as Assessed by Investigator [Time Frame: Approximately 4 years], 3.Progression-free Survival (PFS) [Time Frame: Approximately 4 years], 4.Overall Survival (OS) [Time Frame: Approximately 4 years], 5.Maximum (Peak) Observed Serum Drug Concentration (Cmax) of Rina-S Related Analytes [Time Frame: Approximately 12 months], 6.Time to Reach Maximum (Peak) Serum Drug Concentration (Tmax) of Rina-S Related Analytes[Time Frame: Approximately 12 months], 7.Number of Participants with Antidrug Antibodies (ADAs) [Time Frame: Approximately 12 months], 8.Number of Participants with Treatment-emergent Adverse Events (TEAEs) [Time Frame: Approximately 4 years] Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as Assessed by Investigator [Time Frame: Approximately 3 years]
Description
1.Duration of Response (DOR) per RECIST v1.1 as Assessed by Investigator [Time Frame: Approximately 4 years], 2.Disease Control Rate (DCR) per RECIST v1.1 as Assessed by Investigator [Time Frame: Approximately 4 years], 3.Progression-free Survival (PFS) [Time Frame: Approximately 4 years], 4.Overall Survival (OS) [Time Frame: Approximately 4 years], 5.Maximum (Peak) Observed Serum Drug Concentration (Cmax) of Rina-S Related Analytes [Time Frame: Approximately 12 months], 6.Time to Reach Maximum (Peak) Serum Drug Concentration (Tmax) of Rina-S Related Analytes[Time Frame: Approximately 12 months], 7.Number of Participants with Antidrug Antibodies (ADAs) [Time Frame: Approximately 12 months], 8.Number of Participants with Treatment-emergent Adverse Events (TEAEs) [Time Frame: Approximately 4 years]
Who can participate
Age group: 18-64 years, 65+ years Gender: Female, Male Target enrollment: 107 participants
Interventions
PEGFILGRASTIM
Drug
Rinatabart Sesutecan
Drug
Locations 8
Belgium (1)
France (1)
Germany (1)
Hungary (1)
Italy (1)
Netherlands (1)
Poland (1)
Spain (1)
Technical details
Status
Recruiting
Phase
Phase 2
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
14.04.2026
Registry ID
2025-522107-18-00
Source
euclinicaltrials.eu
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