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

Status: Recruiting
Location: See all (8) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Participant has histologically or cytologically confirmed metastatic or locally advanced NSCLC of adenocarcinoma histology, not amenable to curative surgery or radiotherapy.

• Participant must have radiological disease progression while on or after receiving the most recent regimen.

• Participants either may have actionable genetic alterations (AGAs) or no AGAs.

• Participant has measurable disease according to RECIST v1.1.

• Participant has an Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 or 1 within 7 days of Cycle 1 Day 1.

Locations
United States
California
Providence Medical Foundation (St. Joseph Heritage Healthcare)
RECRUITING
Santa Rosa
Nebraska
Nebraska Hematology-Oncology
RECRUITING
Lincoln
New Jersey
Astera Cancer Care
RECRUITING
East Brunswick
New York
ONE Onc: New York Oncology Hematology
RECRUITING
Albany
Virginia
Virginia Cancer Specialists
RECRUITING
Fairfax
Other Locations
Japan
Kyoto Prefectural University of Medicine
RECRUITING
Kyoto
Japan Community Health Care Organization Chukyo Hospital
RECRUITING
Nagoya
NHO Kinki Chuo Chest Medical Center
RECRUITING
Sakai
Contact Information
Primary
Genmab Trial Information
clinicaltrials@genmab.com
+4570202728
Time Frame
Start Date: 2026-01-30
Estimated Completion Date: 2028-11-22
Participants
Target number of participants: 240
Treatments
Experimental: Rina-S
Multiple cohorts (Cohorts A, B, C, D, and E) will receive Rina-S as monotherapy.
Sponsors
Leads: Genmab

This content was sourced from clinicaltrials.gov

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