Rina-S for Endometrial Cancer

(RAINFOL-03 Trial)

Recruiting at 2 trial locations

Overseen By Genmab Trial Information

Age: 18+

Sex: Female

Trial Phase: Phase 3

Sponsor: Genmab

Must be taking: Platinum-based, PD(L)-1 inhibitors

Must not be taking: Topoisomerase 1 inhibitors

Disqualifiers: Other malignancies, CNS metastases, GI obstruction, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 4-6 months

544 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called Rina-S for individuals with endometrial cancer that has recurred or worsened after previous treatments. The researchers aim to determine if Rina-S is more effective than standard chemotherapy options like paclitaxel or doxorubicin. Participants have a 50% chance of receiving either Rina-S or one of the standard chemotherapies. The trial seeks individuals diagnosed with endometrial cancer who have undergone at least one but no more than three previous treatments and have experienced cancer progression after their last treatment. As a Phase 3 trial, this study represents the final step before potential FDA approval, offering participants a chance to contribute to a treatment that could soon become widely available.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Rina-S has a manageable safety profile for patients with advanced endometrial cancer. In previous studies, participants did not experience serious side effects such as eye or lung problems. The safety data aligns with earlier findings, indicating that Rina-S is generally well-tolerated. Although Rina-S remains under study, it has received a Breakthrough Therapy Designation from the FDA. This designation indicates promise in effectively treating serious conditions, which is a positive sign for its safety and effectiveness. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for endometrial cancer?

Researchers are excited about Rina-S for endometrial cancer because it offers a potentially new approach to treatment. Unlike traditional chemotherapy options like paclitaxel and doxorubicin, which attack cancer cells broadly, Rina-S may work by targeting specific pathways involved in cancer growth, potentially reducing side effects and improving effectiveness. This targeted action could mean a more personalized treatment option, which is why there's a buzz around its potential benefits.

What evidence suggests that Rina-S might be an effective treatment for endometrial cancer?

Research has shown that Rina-S, which participants in this trial may receive, offers promising results for treating advanced endometrial cancer. In past studies, 50% of patients experienced significant tumor reduction, with some achieving complete remission. Rina-S effectively targets and fights cancer cells and has succeeded in patients who have tried other treatments. The side effects are generally manageable and expected to be tolerable. These findings suggest Rina-S could be a strong option for those with recurring or worsening endometrial cancer. ^{1 2 3 4 6}

Who Is on the Research Team?

Study Official

Principal Investigator

Genmab

Are You a Good Fit for This Trial?

This trial is for individuals with recurrent or progressive endometrial cancer who have previously undergone platinum-based chemotherapy and PD(L)-1 inhibitor treatment. They must show radiographic progression after their most recent therapy. Those ineligible for further platinum-based treatments due to specific reasons may also participate.

Inclusion Criteria

I meet the main requirements to join the study.

Key

I have had platinum-based chemotherapy and PD-1 inhibitor treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Rina-S or investigator's choice of chemotherapy (paclitaxel or doxorubicin) for an average of 4 to 6 months

4-6 months

Visits every 3 weeks for Rina-S or every 4 weeks for paclitaxel/doxorubicin

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Rina-S

Trial Overview The study compares Rina-S (GEN1184) with standard care drugs like paclitaxel or doxorubicin in treating endometrial cancer that has come back or worsened after prior treatment. Participants have a 50% chance of receiving either Rina-S or a chemotherapy agent, with no placebos involved.

How Is the Trial Designed?

Group I: Rina-S Experimental Treatment 1 Intervention

Participants will receive Rina-S on Day 1 once every 3 weeks (Q3W).

Group II: IC Active Control 1 Intervention

Participants will receive one of the following chemotherapies at the discretion of the investigator: * Paclitaxel on Days 1, 8, and 15 every 4 weeks (Q4W). * Doxorubicin on Day 1 Q3W.

Who Is Running the Clinical Trial?

Genmab

Lead Sponsor

Trials

76

Recruited

15,300+

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

1. ir.genmab.com ir.genmab.com/news-releases/news-release-details/genmab-announces-new-data-demonstrating-investigational

Genmab Announces New Data Demonstrating ... The study showed that at a median study follow-up of one year, treatment with Rina-S 100 mg/m² every 3 weeks (Q3W) resulted in a 50.0% confirmed ...

2. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.3039

Rinatabart sesutecan (Rina-S) for patients with advanced ... Conclusions: Rina-S showed encouraging anti-tumor activity in pts with heavily pretreated EC and had a manageable safety profile consistent with ...

3. curetoday.com curetoday.com/view/rina-s-yields-50-response-rate-in-advanced-endometrial-cancer

Rina-S Yields 50% Response Rate in Advanced ... Rina-S showed a 50% confirmed response rate in heavily pretreated advanced endometrial cancer patients, with two complete responses observed.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT07166094

NCT07166094 | Study to Assess the Efficacy and Safety of ... There is an equal (50:50) chance of getting either Rina-S or a chemotherapy agent as treatment in this study. The study duration will be approximately 3 years.

5. cancernetwork.com cancernetwork.com/view/rina-s-earns-fda-breakthrough-therapy-designation-in-endometrial-cancer

Rina-S Earns FDA Breakthrough Therapy Designation in ... Data from the phase 1/2 RAINFOL-01 trial support the agency's regulatory decision on rinatabart sesutecan in advanced endometrial cancer.

6. annalsofoncology.org annalsofoncology.org/article/S0923-7534(24)02300-7/fulltext

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 EC ...