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Recruiting

Study to Assess the Efficacy and Safety of Rina-S in Participants With Non-small Cell Lung Cancer

NCT07288177 · Genmab
In plain English

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Official title
A Phase 2, Open-label, Multicohort Study of Rinatabart Sesutecan (Rina-S) in Participants With Non-Small Cell Lung Cancer
About this study
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.
Eligibility criteria
Key Inclusion Criteria: * 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. Key Exclusion Criteria (all study cohorts): * Participant has NSCLC with histology other than adenocarcinoma * Participant has a past or current malignancy other than the inclusion diagnosis before the planned first dose of trial treatment, or any evidence of residual disease from a previously diagnosed malignancy. Exceptions are malignancies with a negligible risk of metastasis or death (eg, 5-year OS ≥ 90%), including, but not limited to, adequately treated cervical carcinoma of stage 1B or less, in situ basal cell or squamous cell skin carcinoma, in situ bladder cancer, ductal carcinoma in situ, or any past malignancy considered cured for ≥ 3 years. * Participants with newly identified or known unstable (eg, progressing brain metastases) or symptomatic central nervous system (CNS) metastases or history of carcinomatous meningitis (also known as leptomeningeal disease). Participants with history of spinal cord compression (from disease). Participants with previous CNS-directed therapy (eg, radiotherapy and/or surgery) for brain metastases may participate provided lesion(s) are radiologically stable (ie, without evidence of progression) for at least 28 days by repeat imaging. Note: Other protocol-defined Inclusion and Exclusion criteria may apply.
Study design
Enrollment target: 240 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2026-01-30
Estimated completion: 2028-11-22
Last updated: 2026-08-26
Interventions
Drug: Rina-S
Primary outcomes
  • Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as Assessed by Investigator (Approximately 3 years)
Sponsor
Genmab · industry
Contacts & investigators
ContactGenmab Trial Information · contact · clinicaltrials@genmab.com · +4570202728
InvestigatorStudy Official · study_director, Genmab
All locations (74)
Compassionate Cancer Care CenterRecruiting
Fountain Valley, California, United States
Kaiser Permanente San Diego Mission RoadRecruiting
San Diego, California, United States
Providence Medical Foundation (St. Joseph Heritage Healthcare)Recruiting
Santa Rosa, California, United States
MedStar Georgetown University HospitalRecruiting
Washington D.C., District of Columbia, United States
Moffitt Cancer Center and Research InstituteRecruiting
Tampa, Florida, United States
Emory Winship Cancer InstituteRecruiting
Atlanta, Georgia, United States
St. Vincent Frontier Cancer CenterRecruiting
Billings, Montana, United States
Nebraska Hematology-OncologyRecruiting
Lincoln, Nebraska, United States
Astera Cancer CareRecruiting
East Brunswick, New Jersey, United States
ONE Onc: New York Oncology HematologyRecruiting
Albany, New York, United States
Montefiore Medical ParkRecruiting
The Bronx, New York, United States
UNC Health - University of North CarolinaRecruiting
Chapel Hill, North Carolina, United States
Williamette Valley Cancer Institute and Research CenterRecruiting
Eugene, Oregon, United States
Providence Portland Medical CenterRecruiting
Portland, Oregon, United States
Providence Oncology & Hematology Care Clinic - WestsideRecruiting
West Haven-Sylvan, Oregon, United States
Tennessee Oncology - Nashville St. Thomas Midtown ClinicRecruiting
Nashville, Tennessee, United States
Tennessee Oncology Nashville - SCRI Oncology PartnersRecruiting
Nashville, Tennessee, United States
Baylor Charles A. Sammons Cancer CenterRecruiting
Dallas, Texas, United States
Virginia Cancer SpecialistsRecruiting
Fairfax, Virginia, United States
St Andrews Medical CentreRecruiting
Adelaide, Australia
Chris O'Brien LifehouseRecruiting
Camperdown, Australia
Icon Cancer Centre HobartRecruiting
Hobart, Australia
Icon Cancer Care - TownsvilleRecruiting
Hyde Park, Australia
St John of God Murdoch HospitalRecruiting
Murdoch, Australia
GenesisCare North ShoreRecruiting
Saint Leonards, Australia
Chu Helora Hospital La Louvière Site JolimontRecruiting
La Louvière, Belgium
UZ Leuven - Gasthuisberg CampusRecruiting
Leuven, Belgium
AZ Delta (Campus Wilgenstraat)Recruiting
Roeselare, Belgium
Shanghai East HospitalRecruiting
Shanghai, Pudong, China
Beijing Chest Tumor HospitalRecruiting
Beijing, China
Tianjin Medical University Cancer Institute and HospitalRecruiting
Tianjin, China
The First Affiliated Hospital of Hebei North UniversityRecruiting
Zhangjiakou, China
Henan Cancer HospitalRecruiting
Zhengzhou, China
Assistance Publique Hôpitaux de Marseille - Hôpital NordRecruiting
Marseille, France
Cochin HospitalRecruiting
Paris, France
Groupe Hospitalier Paris Saint-JosephRecruiting
Paris, France
Institut Curie - Centre de RechercheRecruiting
Paris, France
Lyon Sud Hospital CenterRecruiting
Pierre-Bénite, France
Evangelische Lungenklinik BerlinRecruiting
Berlin, Germany
Universitaetsklinikum EssenRecruiting
Essen, Germany
Krankenhaus Martha-Maria Halle-DölauRecruiting
Halle, Germany
Bács-Kiskun Megyei Kórház - KecskemétRecruiting
Kecskemét, Hungary
Szent Borbála HospitalRecruiting
Tatabánya, Hungary
Istituto di Candiolo - IRCCSRecruiting
Candiolo, Italy
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)Recruiting
Meldola, Italy
Kitasato University HospitalRecruiting
Sagamihara, Kanagawa, Japan
Kanagawa Cardiovascular and Respiratory CenterRecruiting
Yokohama, Kanagawa, Japan
Kyoto Prefectural University of MedicineRecruiting
Kyoto, Kyoto, Japan
Japan Community Health Care Organization Chukyo HospitalRecruiting
Nagoya, Minami Ward, Japan
Saitama Medical University International Medical CenterRecruiting
Saitama, Moroyama, Japan
NHO Kinki Chuo Chest Medical CenterRecruiting
Sakai, Osaka, Japan
Tokyo Metropolitan Cancer and Infectious diseases Center Komagome HospitalRecruiting
Tokyo, Japan
The Netherlands Cancer Institute (NKI)Recruiting
Amsterdam, Netherlands
Leids Universitair Medisch CentrumRecruiting
Leiden, Netherlands
Gdański Uniwersytet MedycznyRecruiting
Gdansk, Poland
KOMED Roman Karaszewski I Wspolnicy Spolka JawnaRecruiting
Krakow, Poland
Instytut MSFRecruiting
Lodz, Poland
MedPoloniaRecruiting
Poznan, Poland
Hospital Germans Trias i PujolRecruiting
Barcelona, Spain
Parc de Salut Mar - Hospital del MarRecruiting
Barcelona, Spain
USP Instituto Universitario DexeusRecruiting
Barcelona, Spain
START RiojaRecruiting
Logroño, Spain
Clinica Universidad de Navarra - MadridRecruiting
Madrid, Spain
Hospital Universitario 12 de OctubreRecruiting
Madrid, Spain
MD Anderson Cancer Center MadridRecruiting
Madrid, Spain
Hospital Quirón MálagaRecruiting
Málaga, Spain
Clinica Universidad de Navarra - PamplonaRecruiting
Pamplona, Spain
Fundación IVO. Instituto Valenciano de OncologíaRecruiting
Valencia, Spain
Hospital Clinico Universitario de ValenciaRecruiting
Valencia, Spain
Changhua Christian HospitalRecruiting
Changhua, Taiwan
Kaohsiung Medical University Chung-Ho Memorial HospitalRecruiting
Kaohsiung City, Taiwan
Taipei Medical University - Shuang Ho Hospital, Ministry of Health and WelfareRecruiting
New Taipei City, Taiwan
Chi Mei Medical Center - LiouyingRecruiting
Tainan, Taiwan
National Cheng Kung UniversityRecruiting
Tainan, Taiwan
Study to Assess the Efficacy and Safety of Rina-S in Participants With Non-small Cell Lung Cancer · TrialPath