Study to Assess the Efficacy and Safety of Rina-S in Participants With Non-small Cell Lung Cancer (RAINFOL-05)

August 25, 2026 updated by: Genmab

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

240

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
      • Adelaide, Australia
        • Recruiting
        • St Andrews Medical Centre
      • Camperdown, Australia
        • Recruiting
        • Chris O'Brien Lifehouse
      • Hobart, Australia
        • Recruiting
        • Icon Cancer Centre Hobart
      • Hyde Park, Australia
        • Recruiting
        • Icon Cancer Care - Townsville
      • Murdoch, Australia
        • Recruiting
        • St John of God Murdoch Hospital
      • Saint Leonards, Australia
        • Recruiting
        • GenesisCare North Shore
  • Belgium
      • La Louvière, Belgium
        • Recruiting
        • Chu Helora Hospital La Louvière Site Jolimont
      • Leuven, Belgium
        • Recruiting
        • UZ Leuven - Gasthuisberg Campus
      • Roeselare, Belgium
        • Recruiting
        • AZ Delta (Campus Wilgenstraat)
  • China
      • Beijing, China
        • Recruiting
        • Beijing Chest Tumor Hospital
      • Tianjin, China
        • Recruiting
        • Tianjin Medical University Cancer Institute and Hospital
      • Zhangjiakou, China
        • Recruiting
        • The First Affiliated Hospital of Hebei North University
      • Zhengzhou, China
        • Recruiting
        • Henan Cancer Hospital
    • Pudong
      • Shanghai, Pudong, China
        • Recruiting
        • Shanghai East Hospital
  • France
      • Marseille, France
        • Recruiting
        • Assistance Publique Hôpitaux de Marseille - Hôpital Nord
      • Paris, France
        • Recruiting
        • Groupe Hospitalier Paris Saint-Joseph
      • Paris, France
        • Recruiting
        • Cochin Hospital
      • Paris, France
        • Recruiting
        • Institut Curie - Centre de Recherche
      • Pierre-Bénite, France
        • Recruiting
        • Lyon Sud Hospital Center
  • Germany
      • Berlin, Germany
        • Recruiting
        • Evangelische Lungenklinik Berlin
      • Essen, Germany
        • Recruiting
        • Universitaetsklinikum Essen
      • Halle, Germany
        • Recruiting
        • Krankenhaus Martha-Maria Halle-Dölau
  • Hungary
      • Kecskemét, Hungary
        • Recruiting
        • Bács-Kiskun Megyei Kórház - Kecskemét
      • Tatabánya, Hungary
        • Recruiting
        • Szent Borbála Hospital
  • Italy
      • Candiolo, Italy
        • Recruiting
        • Istituto di Candiolo - IRCCS
      • Meldola, Italy
        • Recruiting
        • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)
  • Japan
      • Tokyo, Japan
        • Recruiting
        • Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
    • Kanagawa
      • Sagamihara, Kanagawa, Japan
        • Recruiting
        • Kitasato University Hospital
      • Yokohama, Kanagawa, Japan
        • Recruiting
        • Kanagawa Cardiovascular and Respiratory Center
    • Kyoto
      • Kyoto, Kyoto, Japan
        • Recruiting
        • Kyoto Prefectural University of Medicine
    • Minami Ward
      • Nagoya, Minami Ward, Japan
        • Recruiting
        • Japan Community Health Care Organization Chukyo Hospital
    • Moroyama
      • Saitama, Moroyama, Japan
        • Recruiting
        • Saitama Medical University International Medical Center
    • Osaka
      • Sakai, Osaka, Japan
        • Recruiting
        • NHO Kinki Chuo Chest Medical Center
  • Netherlands
      • Amsterdam, Netherlands
        • Recruiting
        • The Netherlands Cancer Institute (NKI)
      • Leiden, Netherlands
        • Recruiting
        • Leids Universitair Medisch Centrum
  • Poland
      • Gdansk, Poland
        • Recruiting
        • Gdanski Uniwersytet Medyczny
      • Krakow, Poland
        • Recruiting
        • KOMED Roman Karaszewski I Wspolnicy Spolka Jawna
      • Lodz, Poland
        • Recruiting
        • Instytut MSF
      • Poznan, Poland
        • Recruiting
        • MedPolonia
  • Spain
      • Barcelona, Spain
        • Recruiting
        • Hospital Germans Trías i Pujol
      • Barcelona, Spain
        • Recruiting
        • Parc de Salut Mar - Hospital del Mar
      • Barcelona, Spain
        • Recruiting
        • USP Instituto Universitario Dexeus
      • Logroño, Spain
        • Recruiting
        • START Rioja
      • Madrid, Spain
        • Recruiting
        • Hospital Universitario 12 de Octubre
      • Madrid, Spain
        • Recruiting
        • MD Anderson Cancer Center Madrid
      • Madrid, Spain
        • Recruiting
        • Clinica Universidad de Navarra - Madrid
      • Málaga, Spain
        • Recruiting
        • Hospital Quirón Málaga
      • Pamplona, Spain
        • Recruiting
        • Clinica Universidad de Navarra - Pamplona
      • Valencia, Spain
        • Recruiting
        • Hospital Clínico Universitario de Valencia
      • Valencia, Spain
        • Recruiting
        • Fundación IVO. Instituto Valenciano de Oncología
  • Taiwan
      • Changhua, Taiwan
        • Recruiting
        • Changhua Christian Hospital
      • Kaohsiung City, Taiwan
        • Recruiting
        • Kaohsiung Medical University Chung-Ho Memorial Hospital
      • New Taipei City, Taiwan
        • Recruiting
        • Taipei Medical University - Shuang Ho Hospital, Ministry of Health and Welfare
      • Tainan, Taiwan
        • Recruiting
        • National Cheng Kung University
      • Tainan, Taiwan
        • Recruiting
        • Chi Mei Medical Center - Liouying
  • United States
    • California
      • Fountain Valley, California, United States, 92708
        • Recruiting
        • Compassionate Cancer Care Center
      • San Diego, California, United States, 92108
        • Recruiting
        • Kaiser Permanente San Diego Mission Road
      • Santa Rosa, California, United States, 95403
        • Recruiting
        • Providence Medical Foundation (St. Joseph Heritage Healthcare)
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20007
        • Recruiting
        • MedStar Georgetown University Hospital
    • Florida
      • Tampa, Florida, United States, 33612
        • Recruiting
        • Moffitt Cancer Center and Research Institute
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • Emory Winship Cancer Institute
    • Montana
      • Billings, Montana, United States, 59102
        • Recruiting
        • St. Vincent Frontier Cancer Center
    • Nebraska
      • Lincoln, Nebraska, United States, 68506
        • Recruiting
        • Nebraska Hematology-Oncology
    • New Jersey
      • East Brunswick, New Jersey, United States, 08816
        • Recruiting
        • Astera Cancer Care
    • New York
      • Albany, New York, United States, 12206
        • Recruiting
        • ONE Onc: New York Oncology Hematology
      • The Bronx, New York, United States, 10461
        • Recruiting
        • Montefiore Medical Park
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
        • Recruiting
        • UNC Health - University of North Carolina
    • Oregon
      • Eugene, Oregon, United States, 97401
        • Recruiting
        • Williamette Valley Cancer Institute and Research Center
      • Portland, Oregon, United States, 97213
        • Recruiting
        • Providence Portland Medical Center
      • West Haven-Sylvan, Oregon, United States, 97225
        • Recruiting
        • Providence Oncology & Hematology Care Clinic - Westside
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • Tennessee Oncology - Nashville St. Thomas Midtown Clinic
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • Tennessee Oncology Nashville - SCRI Oncology Partners
    • Texas
      • Dallas, Texas, United States, 75246
        • Recruiting
        • Baylor Charles A. Sammons Cancer Center
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Recruiting
        • Virginia Cancer Specialists

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Rina-S
Multiple cohorts (Cohorts A, B, C, D, and E) will receive Rina-S as monotherapy.
Drug: Rina-S
Intravenous (IV) infusion.
Other Names:
  • PRO1184
  • Rinatabart Sesutecan
  • GEN1184

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as Assessed by Investigator
Time Frame: Approximately 3 years
Approximately 3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Duration of Response (DOR) per RECIST v1.1 as Assessed by Investigator
Time Frame: Approximately 4 years
Approximately 4 years
Disease Control Rate (DCR) per RECIST v1.1 as Assessed by Investigator
Time Frame: Approximately 4 years
Approximately 4 years
Progression-free Survival (PFS)
Time Frame: Approximately 4 years
Approximately 4 years
Overall Survival (OS)
Time Frame: Approximately 4 years
Approximately 4 years
Maximum (Peak) Observed Serum Drug Concentration (Cmax) of Rina-S Related Analytes
Time Frame: Approximately 12 months
Approximately 12 months
Time to Reach Maximum (Peak) Serum Drug Concentration (Tmax) of Rina-S Related Analytes
Time Frame: Approximately 12 months
Approximately 12 months
Number of Participants with Antidrug Antibodies (ADAs)
Time Frame: Approximately 12 months
Approximately 12 months
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Time Frame: Approximately 4 years
Approximately 4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Genmab

Investigators

  • Study Director: Study Official, Genmab

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 30, 2026

Primary Completion (Estimated)

November 22, 2027

Study Completion (Estimated)

November 22, 2028

Study Registration Dates

First Submitted

December 15, 2025

First Submitted That Met QC Criteria

December 15, 2025

First Posted (Actual)

December 17, 2025

Study Record Updates

Last Update Posted (Actual)

August 26, 2026

Last Update Submitted That Met QC Criteria

August 25, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GCT1184-05
  • 2025 (U.S. NIH Grant/Contract: Faculty of Social Sciences Scientific Grant at the University of Gdańsk)
  • 2025-522107-18-00 (Ctis)
  • jRCT2041250176 (Registry Identifier: Japan Registry for Clinical Trials (jRCT))
  • CTR20260819 (Registry Identifier: Chinadrugtrials.org.cn)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe