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

New Lung Cancer Drug Trial: Rinatabart Sesutecan (Rina-S) for Advanced NSCLC

NCT: NCT07288177 · Status: RECRUITING · Phase: Phase 2 · Sponsor: Genmab · Started: 2026-01-30 · Est. Completion: 2028-11-22

Plain English Summary

Study to Assess the Efficacy and Safety of Rina-S in Participants With Non-small Cell Lung Cancer is a Phase 2 clinical trial sponsored by Genmab studying Non-small Cell Lung Cancer (NSCLC). This study tests a new drug called Rina-S to see how well it works against non-small cell lung cancer (NSCLC). It is for adults with advanced or metastatic NSCLC, specifically adenocarcinoma, whose cancer has progressed after previous treatments. Participants will receive Rina-S intravenously, with regular clinic visits for monitoring. Treatment continues as long as it is effective and safe. There are no placebo treatments; all participants receive the active drug. The trial aims to enroll 240 participants.

Official 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.

Who Can Participate

Here is what you need to know about eligibility for this trial. Adults with non-small cell lung cancer (adenocarcinoma type) that has spread or is locally advanced and has not responded to prior treatment. Patients must have measurable disease and be in good general health (ECOG performance status 0 or 1). Individuals with other types of lung cancer, active brain metastases, or certain other medical conditions may not be eligible. Previous treatments for lung cancer are allowed, but the cancer must have progressed on or after the most recent therapy. This trial is studying Non-small Cell Lung Cancer (NSCLC), so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.

What They're Measuring

The main goal is to measure how many patients respond to Rina-S, meaning their tumors shrink or disappear, which indicates the drug is effectively controlling the cancer. The specific primary outcome measures are: Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as Assessed by Investigator (Approximately 3 years). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This trial is in Phase 2, which tests whether the treatment actually works against the target condition. Phase 2 trials involve 100-300 patients and continue to monitor safety while evaluating effectiveness. This phase often tests different dosages to find the optimal amount. About 33% of Phase 2 drugs advance to Phase 3. If successful, the treatment will move to large-scale Phase 3 trials needed for FDA approval.

Why This Trial Matters

This trial addresses a need for new treatments for advanced non-small cell lung cancer, particularly for patients whose disease has progressed after existing therapies. Phase 2 success would typically lead to larger Phase 3 trials needed for regulatory approval. This research targets Non-small Cell Lung Cancer (NSCLC), where improved treatment options are needed.

Investor Insight

This Phase 2 trial of Rina-S in NSCLC, sponsored by Genmab, signals potential for a new treatment option in a large market, with a focus on efficacy and safety to support future development. Phase 2 trials have approximately a 15-20% chance of eventually gaining FDA approval.

Is This Trial Right for Me?

Ask your doctor if Rina-S is a suitable option for your specific type of lung cancer and if you meet the study's requirements. Be prepared for regular clinic visits for drug infusions and various tests, including blood work and imaging scans. Understand that treatment duration varies, and you may continue treatment for an extended period if it is working well and you tolerate it without serious side effects. This trial is currently recruiting participants. The trial is being conducted at 8 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

Interventions

Primary Outcomes

Secondary Outcomes

Full 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.

Trial Locations

Frequently Asked Questions

What is clinical trial NCT07288177?

NCT07288177 is a Phase 2 INTERVENTIONAL study titled "Study to Assess the Efficacy and Safety of Rina-S in Participants With Non-small Cell Lung Cancer." It is currently recruiting and is sponsored by Genmab. The trial targets enrollment of 240 participants.

What conditions does NCT07288177 study?

This trial investigates treatments for Non-small Cell Lung Cancer (NSCLC). The primary condition under study is Non-small Cell Lung Cancer (NSCLC).

What treatments are being tested in NCT07288177?

The interventions being studied include: Rina-S (DRUG). Intravenous (IV) infusion.

What does Phase 2 mean for NCT07288177?

Phase 2 trials test whether the treatment works for the intended condition. They involve 100-300 patients and continue to evaluate safety while measuring effectiveness.

What is the current status of NCT07288177?

This trial is currently "Recruiting." It started on 2026-01-30. The estimated completion date is 2028-11-22.

Who is sponsoring NCT07288177?

NCT07288177 is sponsored by Genmab. The sponsor is responsible for funding, designing, and overseeing the clinical trial.

How many people can participate in NCT07288177?

The trial aims to enroll 240 participants. The trial is currently recruiting and accepting new participants.

How is NCT07288177 designed?

This is a interventional study, uses na allocation, follows a single_group design, employs none masking.

What are the primary outcomes being measured in NCT07288177?

The primary outcome measures are: Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as Assessed by Investigator (Approximately 3 years). These are the main endpoints researchers use to determine whether the treatment is effective.

Where is NCT07288177 being conducted?

This trial is being conducted at 8 sites, including Santa Rosa, California; Lincoln, Nebraska; East Brunswick, New Jersey; Albany, New York and 4 more sites (United States, Japan).

Where can I find official information about NCT07288177?

The official record for NCT07288177 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT07288177. This government database provides the most up-to-date and detailed information about the trial.

What is NCT07288177 testing in simple terms?

This study tests a new drug called Rina-S to see how well it works against non-small cell lung cancer (NSCLC). It is for adults with advanced or metastatic NSCLC, specifically adenocarcinoma, whose cancer has progressed after previous treatments.

Why is this trial significant?

This trial addresses a need for new treatments for advanced non-small cell lung cancer, particularly for patients whose disease has progressed after existing therapies.

What are the potential risks of participating in NCT07288177?

Common side effects may include fatigue, nausea, diarrhea, and changes in blood counts. More serious risks could involve allergic reactions, lung problems, or effects on the heart or liver. It is important to report any new or worsening symptoms to your healthcare team immediately. As with any clinical trial, participants are closely monitored and can withdraw at any time.

Should I consider participating in NCT07288177?

Ask your doctor if Rina-S is a suitable option for your specific type of lung cancer and if you meet the study's requirements. Be prepared for regular clinic visits for drug infusions and various tests, including blood work and imaging scans. Understand that treatment duration varies, and you may continue treatment for an extended period if it is working well and you tolerate it without serious side effects. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.

What does NCT07288177 signal from an investment perspective?

This Phase 2 trial of Rina-S in NSCLC, sponsored by Genmab, signals potential for a new treatment option in a large market, with a focus on efficacy and safety to support future development. This is a Phase 2 trial, which is focused on confirming efficacy before larger pivotal studies.

What happens if the treatment in this trial doesn't work?

Participants will receive Rina-S intravenously, with regular clinic visits for monitoring. Treatment continues as long as it is effective and safe. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.

Related Conditions

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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.