Ubamatamab Combination Therapy for Ovarian Cancer

Recruiting at 32 trial locations

Overseen By Clinical Trials Administrator

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: Regeneron Pharmaceuticals

Disqualifiers: Other malignancy, Brain tumor, Infections, others

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

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

220 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores an experimental drug called ubamatamab for individuals with advanced ovarian cancer. Researchers aim to assess the safety and effectiveness of this drug both alone and in combination with other cancer treatments. They also monitor side effects and the body's response to the drug. This trial may suit those with advanced ovarian cancer that has progressed despite previous treatments and who have at least one measurable tumor. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group of participants.

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 this trial's treatments are likely to be safe?

Research has shown that ubamatamab has a good safety record from earlier studies. Patients with advanced ovarian cancer tolerated the treatment well, even after other therapies. This indicates that the side effects were manageable and did not outweigh the potential benefits. The studies also found that ubamatamab could lead to lasting improvements, offering hope for those with limited options. While experimental treatments always carry risks, current evidence suggests that ubamatamab is generally well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Ubamatamab is unique because it offers a fresh approach to treating ovarian cancer by targeting specific proteins that are overexpressed in cancer cells. Unlike traditional chemotherapy, which affects both cancerous and healthy cells, Ubamatamab aims to selectively bind to these cancer cell proteins, potentially reducing side effects and improving treatment precision. Researchers are excited about this treatment as it represents a novel mechanism of action that could enhance effectiveness and provide new hope for patients who may not respond well to existing therapies.

What evidence suggests that this trial's treatments could be effective for ovarian cancer?

Research has shown that ubamatamab may help treat advanced ovarian cancer. In studies, about 14% of patients experienced improvement with ubamatamab alone, with benefits lasting around 12 to 14 months. In this trial, participants will receive ubamatamab combined with other treatments, which previous studies suggest may slightly increase the improvement rate to about 18%. The drug enhances the body's immune system to better target cancer cells. While these results are promising, effectiveness can vary, and further research is needed to fully understand its benefits. ^{2 3 6 7 8}

Who Is on the Research Team?

Clinical Trial Management

Principal Investigator

Regeneron Pharmaceuticals

Are You a Good Fit for This Trial?

This trial is for adults with advanced serous or endometrioid ovarian, primary peritoneal, or fallopian tube cancer that's resistant to platinum-based treatments. Participants should be in good physical condition (ECOG 0-1) and have proper organ/bone marrow function. They must show disease progression on prior therapy and have at least one measurable lesion.

Inclusion Criteria

I have advanced ovarian, peritoneal, or fallopian tube cancer, but not clear cell, mucinous, or carcinosarcoma.

My cancer has grown despite treatment, and I have at least one tumor that can be measured.

I am fully active or restricted in physically strenuous activity but can do light work.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive ubamatamab alone or in combination with other anti-cancer drugs

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Ubamatamab

Trial Overview The study tests ubamatamab alone and combined with other anti-cancer drugs: bevacizumab, cemiplimab, fianlimab, and PLD (a standard chemo). It aims to assess the safety, tolerability, effectiveness of these combinations and how they affect the body including side effects and immune responses.

How Is the Trial Designed?

Group I: Arm D Experimental Treatment 3 Interventions

Randomization as described in the protocol

Group II: Arm C Experimental Treatment 4 Interventions

Randomization as described in the protocol

Group III: Arm B Experimental Treatment 3 Interventions

Randomization as described in the protocol

Group IV: Arm A2 Experimental Treatment 2 Interventions

Randomization as described in the protocol

Group V: Arm A1 Experimental Treatment 2 Interventions

Randomization as described in the protocol

Who Is Running the Clinical Trial?

Regeneron Pharmaceuticals

Lead Sponsor

Trials

690

Recruited

948,000+

Founded

1988

Headquarters

Tarrytown, USA

Known For

Precision medicine

Top Products

Dupixent, EYLEA, Libtayo, Praluent

Leonard Schleifer

Regeneron Pharmaceuticals

Chief Executive Officer since 1988

MD and PhD in Medicine

George Yancopoulos

Regeneron Pharmaceuticals

Chief Medical Officer since 1997

MD from Harvard Medical School

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S1048891X24114028

Ovarian Cancer PO011LBA/#1512 Ubamatamab ... In efficacy analyses (n=42 monotherapy/n=22 combination), ORR was 14.3%/18.2%, median duration of response was 13.7/8.3 months, and CA125 response (GCIG ...

2. esmoopen.com esmoopen.com/article/S2059-7029(23)00041-8/fulltext

41P Phase I analysis of ubamatamab (MUC16xCD3 ... In 42 pts receiving ≥1 full dose of ≥20 mg, ORR was 14.3% (95% CI, 5.4–28.5), disease control rate was 57.1% (41–72.3), and median duration of response was 12.2 ...

3. onclive.com onclive.com/view/investigation-of-ubamatamab-with-or-without-cemiplimab-continues-in-recurrent-ovarian-cancer

Investigation of Ubamatamab With or Without Cemiplimab ... “Particularly in patients with high-grade serous ovarian cancer, we've seen modest to no efficacy for traditional checkpoint inhibitors, as we ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12316166/

Mucin 16–Directed Therapy in Pediatric Sarcomas The selected dose of ubamatamab (250 mg once per week) was previously demonstrated to be tolerable in adult patients with ovarian cancer.

5. ascopubs.org ascopubs.org/doi/10.1200/JCO.2024.42.16_suppl.TPS5632

A phase 1/2 study of ubamatamab (REGN4018), a MUC16 ... Ubamatamab is a MUC16 × cluster of differentiation 3 (MUC16×CD3) bispecific antibody that bridges MUC16 on tumor cells and CD3 on T cells to promote T-cell– ...

6. annalsofoncology.org annalsofoncology.org/article/S0923-7534(23)02770-9/fulltext

754P Ubamatamab (MUC16xCD3 bispecific antibody) with ... In phase 1 (NCT03564340), ubamatamab monotherapy resulted in an acceptable safety profile and durable responses. ... Patients (pts) with recurrent platinum- ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11627180/

Translational findings support regimen selection for first‐in ... Our findings demonstrate the value of ubamatamab preclinical data to aid efficient FIH study design. Some aspects may be generalized ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT03564340

NCT03564340 | Study of REGN4018 (Ubamatamab) ... Learn about the safety of ubamatamab and to find out what dose of ubamatamab can be given alone or with cemiplimab to patients with ovarian cancer or cancer of ...