Recruiting PHASE2 Ovarian Cancer

New treatment option for Ovarian Cancer

Official title Investigation of Ubamatamab Combination Therapy in Adult Participants With Platinum-Resistant Ovarian Cancer

ClinicalTrials.gov ID: NCT06787612

What this study is testing

What is Ubamatamab?

Ubamatamab is an investigational medicine, being studied as a potential treatment for ovarian cancer.

Also referred to as REGN4018.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
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.
  • Phase 2: a mid-size study of how well it works

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 and older, women only

You may be able to join if

  • Participants with histologically or cytologically confirmed diagnosis of advanced serous or endometrioid ovarian (regardless of the grade), primary...
  • Must have progression on prior therapy documented radiographically and must have at least 1 measurable lesion (not previously irradiated) that can be...
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Adequate organ and bone marrow function, as described in the protocol
  • Platinum-Resistant Ovarian Cancer, as described in the protocol Key

You likely can't join if

  • Major surgical procedure or significant traumatic injury within 4 weeks prior to first dose of study intervention(s)
  • Documented allergic or acute hypersensitivity reaction attributed to antibody treatments or doxorubicin hydrochloride or components of study...
  • Another malignancy that is progressing or requires active treatment, as described in the protocol
  • Untreated or active Central Nervous System (CNS) metastases, or carcinomatous meningitis, as described in the protocol
  • Uncontrolled infections including but not limited to human immunodeficiency virus, hepatitis B or hepatitis C infection, or diagnosis of...
  • Moderate to large or ascites, as described in the protocol
See the full eligibility criteria
Who can join
  • Participants with histologically or cytologically confirmed diagnosis of advanced serous or endometrioid ovarian (regardless of the grade), primary peritoneal, or fallopian tube cancer (clear cell, mucinous, and...
  • Must have progression on prior therapy documented radiographically and must have at least 1 measurable lesion (not previously irradiated) that can be accurately measured by RECIST 1.1
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Adequate organ and bone marrow function, as described in the protocol
  • Platinum-Resistant Ovarian Cancer, as described in the protocol Key
What rules you out
  • Major surgical procedure or significant traumatic injury within 4 weeks prior to first dose of study intervention(s)
  • Documented allergic or acute hypersensitivity reaction attributed to antibody treatments or doxorubicin hydrochloride or components of study intervention(s)
  • Another malignancy that is progressing or requires active treatment, as described in the protocol
  • Untreated or active Central Nervous System (CNS) metastases, or carcinomatous meningitis, as described in the protocol
  • Uncontrolled infections including but not limited to human immunodeficiency virus, hepatitis B or hepatitis C infection, or diagnosis of immunodeficiency
  • Moderate to large or ascites, as described in the protocol
  • Bowel obstruction within last 3 months or current need for parenteral nutrition NOTE: Other protocol-defined inclusion/exclusion criteria apply

The study team makes the final eligibility decision.

Where it's taking place

  • Birmingham, Alabama, United States
  • La Jolla, California, United States
  • Los Angeles, California, United States
  • Jacksonville, Florida, United States
  • Miami, Florida, United States
  • Orlando, Florida, United States
  • Tampa, Florida, United States
  • Chicago, Illinois, United States
  • Westwood, Kansas, United States
  • Louisville, Kentucky, United States
  • Boston, Massachusetts, United States
  • Detroit, Michigan, United States
  • Hilliard, Ohio, United States
  • Portland, Oregon, United States
  • Pittsburgh, Pennsylvania, United States
  • Sioux Falls, South Dakota, United States
  • Dallas, Texas, United States
  • Seattle, Washington, United States
  • Madison, Wisconsin, United States
  • Milwaukee, Wisconsin, United States

+ 22 more site(s).

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Birmingham, Alabama, United States; La Jolla, California, United States; Los Angeles, California, United States; Jacksonville, Florida, United States; Miami, Florida, United States; Orlando, Florida, United States and 36 more location(s). Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.