Rina-S for Lung Cancer
(RAINFOL-05 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a drug called Rina-S to evaluate its effectiveness against lung cancer, specifically adenocarcinoma. All participants will receive the actual drug, not a placebo, for about 12 months, with regular clinic visits for monitoring. The trial targets individuals whose lung cancer has worsened despite previous treatments and is not suitable for surgery or radiation. Participants should have measurable disease and be able to perform daily activities with minimal assistance. The trial aims to determine if Rina-S can stop or slow lung cancer growth. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of people.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that Rina-S is likely to be safe for humans?
Research has shown that Rina-S, the treatment being tested in the trial, has promising safety results from earlier studies. In one study, researchers tested Rina-S on patients with solid tumors, focusing on its safety and any side effects. The results suggested that Rina-S has a consistent safety record.
Importantly, some studies have found that patients did not experience serious side effects like eye damage or lung inflammation. However, reports of other side effects, such as nerve damage, exist, so participants should be aware of this possibility.
Overall, findings so far suggest that Rina-S is generally well-tolerated, with specific side effects that researchers are monitoring closely. This information helps potential participants understand what to expect regarding the safety of Rina-S in the ongoing trial.12345Why do researchers think this study treatment might be promising?
Unlike the standard treatments for lung cancer, which often include chemotherapy, radiation, and targeted therapies, Rina-S acts as a monotherapy with a unique mechanism. Researchers are excited about Rina-S because it targets specific pathways in cancer cells that aren't addressed by the current treatment options. This innovative approach has the potential to be more effective for certain patients and may offer fewer side effects, making it a promising alternative in the fight against lung cancer.
What evidence suggests that Rina-S might be an effective treatment for lung cancer?
Research shows that Rina-S, the investigational treatment studied in this trial, holds promise in fighting tumors, especially for patients who have tried many treatments before. Studies have found that Rina-S is effective against lung cancer cells, particularly the common and challenging type known as non-small cell lung cancer (NSCLC). This treatment targets cancer cells while sparing healthy ones, potentially leading to better patient outcomes. Early findings suggest that Rina-S can slow tumor growth and may even shrink tumors in some cases. Its potential success stems from its ability to target and disrupt cancer cell functions.12367
Who Is on the Research Team?
Study Official
Principal Investigator
Genmab
Are You a Good Fit for This Trial?
This trial is for adults with advanced or metastatic non-small cell lung cancer (NSCLC) of adenocarcinoma type, who have seen their disease progress after treatment. They may or may not have certain genetic changes in their cancer. Participants should be relatively active and well enough to perform daily activities (ECOG score 0-1).Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Rina-S monotherapy. Treatment cycles last 3 weeks, with 1 to 5 visits per cycle. Average treatment duration is 12 months.
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Rina-S
Trial Overview
The study tests the effectiveness and safety of a drug called Rina-S as a solo treatment for NSCLC. All participants will receive Rina-S, with no placebos involved. Treatment can last up to an average of 12 months, depending on individual responses and side effects.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Multiple cohorts (Cohorts A, B, C, D, and E) will receive Rina-S as monotherapy.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Genmab
Lead Sponsor
Dr. Jan van de Winkel
Genmab
Chief Executive Officer since 2010
PhD in Immunology, University of Utrecht
Dr. Judith Klimovsky
Genmab
Chief Medical Officer since 2019
MD, University of Copenhagen
Citations
Study to Assess the Efficacy and Safety of Rina-S in ...
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 ...
2.
ir.genmab.com
ir.genmab.com/news-releases/news-release-details/genmab-announces-new-data-demonstrating-investigationalGenmab Announces New Data Demonstrating ...
Genmab Announces New Data Demonstrating Investigational Rinatabart Sesutecan (Rina-S®) Achieved Anti-Tumor Activity in Heavily Pretreated ...
UCSD Non-Small Cell Lung Cancer Clinical Trials for 2026
This study will test the safety, including side effects, and determine the characteristics of a drug called Rina-S in participants with solid ...
4.
theglobeandmail.com
theglobeandmail.com/investing/markets/stocks/GMAB/pressreleases/36694661/genmabs-rina-s-new-study-targets-lung-cancer-with-innovative-treatment/Genmab's Rina-S: New Study Targets Lung Cancer with ...
This research is significant as it focuses on improving outcomes for NSCLC patients, a common and challenging type of lung cancer. Rina-S, the ...
NCT05579366 | Rinatabart Sesutecan (Rina-S, PRO1184 ...
This study will test the safety, including side effects, and determine the characteristics of a drug called Rina-S in participants with solid tumors.
6.
clinicaltrialsarena.com
clinicaltrialsarena.com/news/asco25-genmabs-rina-s-en-route-to-blockbuster-potential-amid-further-positive-data/ASCO25: Genmab's Rina-S en route to 'blockbuster ...
Part of the market's potential is its increased safety over immunotherapies, though ocular toxicity, neuropathy, and interstitial lung disease ...
719MO A phase I/II study of rinatabart sesutecan (Rina-S) ...
No ocular toxicity or interstitial lung disease was observed. The emerging safety profile of Rina-S in Part B is consistent with Part A. For Part A OC and ...
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