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

Official title

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

Overview

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.

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.

Interventions

• Drug Rina-S
  Intravenous (IV) infusion.

Primary outcome measures

• Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as Assessed by Investigator [Time frame: Approximately 3 years]

Secondary outcome measures (8)

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

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 15 centers

• Compassionate Cancer Care Center — Fountain Valley
• Providence Medical Foundation (St. Joseph Heritage Healthcare) — Santa Rosa
• MedStar Georgetown University Hospital — Washington D.C.
• Moffitt Cancer Center and Research Institute — Tampa
• Emory Winship Cancer Institute — Atlanta
• St. Vincent Frontier Cancer Center — Billings
• Nebraska Hematology-Oncology — Lincoln
• Astera Cancer Care — East Brunswick
• … and 7 more centers

Spain · 10 centers

• Hospital Germans Trias i Pujol — Barcelona
• Parc de Salut Mar - Hospital del Mar — Barcelona
• USP Instituto Universitario Dexeus — Barcelona
• START Rioja — Logroño
• Clinica Universidad de Navarra - Madrid — Madrid
• Hospital Universitario 12 de Octubre — Madrid
• MD Anderson Cancer Center Madrid — Madrid
• Hospital Quirón Málaga — Málaga
• … and 2 more centers

Japan · 7 centers

• Kitasato University Hospital — Sagamihara
• Kanagawa Cardiovascular and Respiratory Center — Yokohama
• Japan Community Health Care Organization Chukyo Hospital — Nagoya
• Saitama Medical University International Medical Center — Saitama
• NHO Kinki Chuo Chest Medical Center — Sakai
• Kyoto Prefectural University of Medicine — Kyoto
• Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital — Tokyo

Australia · 5 centers

• St Andrews Medical Centre — Adelaide
• Icon Cancer Centre Hobart — Hobart
• Icon Cancer Care - Townsville — Hyde Park
• St John of God Murdoch Hospital — Murdoch
• GenesisCare North Shore — Saint Leonards

France · 4 centers

• Cochin Hospital — Paris
• Groupe Hospitalier Paris Saint-Joseph — Paris
• Institut Curie - Centre de Recherche — Paris
• Lyon Sud Hospital Center — Pierre-Bénite

China · 3 centers

• Shanghai East Hospital — Shanghai
• Beijing Chest Tumor Hospital — Beijing
• Tianjin Medical University Cancer Institute and Hospital — Tianjin

Germany · 3 centers

• Evangelische Lungenklinik Berlin — Berlin
• Universitaetsklinikum Essen — Essen
• Krankenhaus Martha-Maria Halle-Dölau — Halle

Poland · 3 centers

• KOMED Roman Karaszewski I Wspolnicy Spolka Jawna — Krakow
• Instytut MSF — Lodz
• MedPolonia — Poznan

Belgium · 2 centers

• Chu Helora Hospital La Louvière Site Jolimont — La Louvière
• AZ Delta (Campus Wilgenstraat) — Roeselare

Hungary · 2 centers

• Bács-Kiskun Megyei Kórház - Kecskemét — Kecskemét
• Szent Borbála Hospital — Tatabánya

Netherlands · 2 centers

• The Netherlands Cancer Institute (NKI) — Amsterdam
• Leids Universitair Medisch Centrum — Leiden

Italy · 1 center

• Istituto di Candiolo - IRCCS — Candiolo

Identifiers

NCT: NCT07288177 · GCT1184-05 · 2025-522107-18-00 · jRCT2041250176 · CTR20260819

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)
• NMPA/CDE CTR20260819 (chinadrugtrials.org.cn platform)

View this study on ClinicalTrials.gov ↗