Ubamatamab Combination Therapy for Ovarian Cancer

Overseen ByClinical Trials Administrator

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: Regeneron Pharmaceuticals

Disqualifiers: Other malignancy, Brain tumor, Infections, others

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

Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This study is researching an experimental drug called ubamatamab, also referred to as "study drug". The study is focused on patients who have advanced ovarian cancer.The aim of the study is to see how safe, tolerable, and effective the study drug is on its own and in combination with other anti-cancer drugs (bevacizumab, cemiplimab, fianlimab and a standard chemotherapy drug, pegylated liposomal doxorubicin \[PLD\]), referred to as "combination drugs'.The study is looking at several other research questions, including:* What side effects may happen from taking the study drug and its experimental combinations* How much study drug and fianlimab is in the blood at different times* Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects) and its combinations

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.

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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?

5Treatment groups

Experimental Treatment

Group I: Arm DExperimental Treatment3 Interventions