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RecruitingInterventionalPhase 2

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

NCT ID: NCT07288177Sponsor: GenmabLast updated: 2026-06-02

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.

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.

Arms & interventions

  • DrugRina-S

    Intravenous (IV) infusion.

Outcome measures

Primary

  • Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as Assessed by Investigator

    Time frame: Approximately 3 years

Secondary

  • 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

Sex: AllAge: 18 Years and olderHealthy volunteers: No
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 locations (8)

Compassionate Cancer Care Center

Fountain Valley, California, 92708

Recruiting

Providence Medical Foundation (St. Joseph Heritage Healthcare)

Santa Rosa, California, 95403

Recruiting

Nebraska Hematology-Oncology

Lincoln, Nebraska, 68506

Recruiting

Astera Cancer Care

East Brunswick, New Jersey, 08816

Recruiting

ONE Onc: New York Oncology Hematology

Albany, New York, 12206

Recruiting

Montefiore Medical Park

The Bronx, New York, 10461

Recruiting

Tennessee Oncology - Nashville St. Thomas Midtown Clinic

Nashville, Tennessee, 37203

Recruiting

Virginia Cancer Specialists

Fairfax, Virginia, 22031

Recruiting