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

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: Non-small Cell Lung Cancer (NSCLC)
• Intervention / Treatment: Drug: Rina-S

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

• Study Contact: Name: Genmab Trial Information; Phone Number: +4570202728; Email: clinicaltrials@genmab.com

Study Locations

• Australia
  • Hobart, Australia
    • Recruiting
    • Icon Cancer Centre Hobart
  • Hyde Park, Australia
    • Recruiting
    • Icon Cancer Care - Townsville
• China
  • Tianjin, China
    • Recruiting
    • Tianjin Medical University Cancer Institute and Hospital
  • Pudong
    • Shanghai, Pudong, China
      • Recruiting
      • Shanghai East Hospital
• Japan
  • Kyoto, Japan
    • Recruiting
    • Kyoto Prefectural University of Medicine
  • Kanagawa
    • Sagamihara, Kanagawa, Japan
      • Recruiting
      • Kitasato University Hospital
    • Yokohama, Kanagawa, Japan
      • Recruiting
      • Kanagawa Cardiovascular and Respiratory Center
  • 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
• Poland
  • Krakow, Poland
    • Recruiting
    • KOMED Roman Karaszewski I Wspolnicy Spolka Jawna
• Spain
  • Madrid, Spain
    • Recruiting
    • MD Anderson Cancer Center Madrid
  • Pamplona, Spain
    • Recruiting
    • Clinica Universidad de Navarra - Pamplona
  • Valencia, Spain
    • Recruiting
    • Hospital Clinico Universitario de Valencia
• United States
  • California
    • Fountain Valley, California, United States, 92708
      • Recruiting
      • Compassionate Cancer Care Center
    • Santa Rosa, California, United States, 95403
      • Recruiting
      • Providence Medical Foundation (St. Joseph Heritage Healthcare)
  • 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
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Recruiting
      • Tennessee Oncology - Nashville St. Thomas Midtown Clinic
  • Virginia
    • Fairfax, Virginia, United States, 22031
      • Recruiting
      • Virginia Cancer Specialists

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

1

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	Approximately 3 years

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Genmab
• Investigators: Study Director: Study Official, Genmab

Study record dates

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): June 2, 2026
• Last Update Submitted That Met QC Criteria: June 1, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: GCT1184-05; 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