MEN2501 for Ovarian Cancer

Overseen By Stemline Trials

Age: 18+

Sex: Female

Trial Phase: Phase 1

Sponsor: Stemline Therapeutics, Inc.

Disqualifiers: Primary platinum-refractory disease, others

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

Compensation: Varies

Number of Visits: Unknown

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called MEN2501 for certain types of ovarian cancer, specifically those resistant to platinum-based chemotherapy. The goal is to assess the treatment's safety and effectiveness and determine the right dose for patients. The trial consists of two parts: one to test different doses and another to optimize the best dose. Ideal participants are those diagnosed with high-grade serous ovarian, primary peritoneal, or fallopian tube cancer who have not responded to platinum-based treatments. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive it.

Will I have to stop taking my current medications?

The trial information does not specify if 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 MEN2501 is likely to be safe for humans?

Since this is the first time MEN2501 is being tested in humans, information about its safety is not yet available. The trial aims to assess how well participants can tolerate MEN2501, a new treatment for ovarian cancer. In this early stage of testing, the study primarily focuses on determining the safest dose and identifying any side effects. Researchers closely observe participants' responses to the treatment. This phase is crucial to ensure MEN2501 is safe enough for future testing in larger groups. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for ovarian cancer, which often involve chemotherapy and targeted therapies like PARP inhibitors, MEN2501 is unique because it focuses on a novel mechanism of action. Researchers are excited about MEN2501 because it targets specific cancer cell processes that are not effectively addressed by existing options. This could potentially lead to better outcomes for patients, particularly those who do not respond well to current therapies. Additionally, MEN2501 is being optimized for dosage and effectiveness, aiming to maximize benefits while minimizing side effects, which is a significant advancement over traditional treatments.

What evidence suggests that MEN2501 might be an effective treatment for ovarian cancer?

Research shows that MEN2501 is a new treatment under testing for ovarian cancer. This trial consists of two parts: Part A focuses on MEN2501 dose escalation, and Part B involves dose expansion and optimization. As this is the first time MEN2501 is being tested in humans, direct evidence on its effectiveness for this condition is not yet available. However, MEN2501 is designed to target specific parts of the cancer that aid its growth, with the aim of slowing or stopping the cancer's progression. Early studies concentrate on its safety and behavior in the body, which are crucial steps before understanding its full potential in treating ovarian cancer. ^{1 5 6 7 8}

Who Is on the Research Team?

Medical Director

Principal Investigator

Stemline Therapeutics, Inc.

Are You a Good Fit for This Trial?

This trial is for adults with ovarian cancer that has stopped responding to platinum-based chemotherapy. Specific eligibility details are not provided, but typically participants must be in good health aside from their cancer and meet certain lab test criteria.

Inclusion Criteria

I have been diagnosed with high-grade serous ovarian, primary peritoneal, or fallopian tube cancer.

Exclusion Criteria

My cancer did not respond to platinum-based chemotherapy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive escalating doses of MEN2501 to evaluate safety and tolerability

8-12 weeks

Dose Expansion & Optimization

Participants receive optimized doses of MEN2501 to further evaluate safety and antitumor activity

12-16 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• MEN2501

Trial Overview The study is testing MEN2501, a new potential treatment for ovarian cancer. It's an early-stage trial assessing how safe the drug is, what dose should be used, and if it works against tumors.

How Is the Trial Designed?

Group I: Part B: MEN2501 Dose Expansion & Optimization Experimental Treatment 1 Intervention

Group II: Part A: MEN2501 Dose Escalation Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Stemline Therapeutics, Inc.

Lead Sponsor

Trials

24

Recruited

6,500+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07226427

A First-in-Human Study of MEN2501 in Participants With ... This is a first-in-human, open-label, dose-escalation, dose-optimization trial designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics ...

2. medical.menarinistemline.com medical.menarinistemline.com/Pipeline/StemlinePipeline

Clinical Trial & Study Pipeline Updates - Menarini Stemline Stay informed about Menarini Oncology's robust clinical trial pipeline and investigational therapies from Stemline Therapeutics. Access detailed updates on ...

3. mdanderson.org mdanderson.org/newsroom/new-genetic-marker-linked-to-improved-survival-with-immunotherapy-in-ovarian-and-other-cancers.h00-159778023.html

New genetic marker linked to improved survival with ... Results of the study found that patients with PPP2R1A-mutant OCCC had a median overall survival (OS) of more than five years (66.9 months) after ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40680290/

Superior Survival Outcomes of Epithelial Ovarian Cancer ... Epithelial ovarian cancer patients in ACTUR had better 5-year overall survival than those in SEER (53.2% vs. 47.7%, log-rank P = .0010). The AHR ...

5. facingourrisk.org facingourrisk.org/research-clinical-trials/results

Research & Clinical Trials Search Results: A First-in-Human Study of MEN2501 in Participants With Platinum-Resistant Ovarian Cancer. NCT07044336, Puxitatug Samrotecan (AZD8205) Monotherapy vs ...

6. meddatax.com meddatax.com/clinical-trials/NCT07226427

A First-in-Human Study of MEN2501 in Participants With ... This is a first-in-human, open-label, dose-escalation, dose-optimization trial designed to evaluate the safety, tolerability, ...

7. facingourrisk.org facingourrisk.org/research-clinical-trials/results/printable

Force Research Search Results | Printable This study will test the safety and effectiveness of the drug sovilnesib in patients with ovarian cancer. High Dose Testosterone Treatment for People with ...

8. stemline.com stemline.com/product-pipeline/

Product Pipeline MEN1309 is currently being tested as a potential treatment for patients with solid tumors. NCT04064359 - Safety and Preliminary Efficacy of OBT076 in Recurrent/ ...