Ubamatamab in Platinum-Resistant Ovarian Cancer

What is the Purpose of this Study?

The purpose of this study is to evaluate an investigational drug called ubamatamab in patients who have advanced ovarian cancer. Researchers want to determine how safe, tolerable, and effective ubamatamab is on its own and in combination with other anti-cancer drugs (bevacizumab, cemiplimab, fianlimab, and a standard chemotherapy drug, pegylated liposomal doxorubicin). The study will also examine the side effects of the study drug and its experimental combinations, as well as whether the body makes antibodies against ubamatamab (which could make the drug less effective or could lead to side effects) and its combinations. Participants will also receive another investigational drug, sarilumab, that is intended to help reduce side effects that may occur when taking ubamatamab. Ubamatamab is a type of medicine called a "bi-specific antibody." Antibodies are proteins that bodies naturally make to fight germs, but scientists can also create them in labs to help treat diseases like cancer. Ubamatamab aims to help T-cells find and destroy ovarian cancer cells.


Eligibility

  • 1. Participants with histologically or cytologically confirmed diagnosis of advanced serous or endometrioid ovarian, primary peritoneal, or fallopian tube cancer (clear cell, mucinous, and carcinosarcoma are excluded)
  • 2. 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
  • 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • 4. Adequate organ and bone marrow function, as described in the protocol
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Where can I participate?

CS Cancer at Cedars-Sinai Medical Center : Abrahm Levi

More about this Clinical Trial

What is the full name of this clinical trial?

R4018-ONC-2445: Multi-Arm Phase 2 study of Ubamatamab with or without additional agents in Platinum - Resistant Ovarian Cancer

Study Details
Disease Type/Condition

Ovary

Principal Investigator

Hafez, Navid

Co-Investigators

Andrew Li, Margaret Liang

Age Group

Adult

Phase

II

IRB Number

STUDY00003993

ClinicalTrials.gov ID

NCT06787612

Key Eligibility
ClinicalTrials.gov

How do I learn more about this study?
Name

Abrahm Levi

Email
Abrahm.Levi@cshs.org
Study Detail
Disease Type/Condition

Ovary

Principal Investigator

Hafez, Navid

Age Group

Adult

Phase

II

IRB Number

R4018-ONC-2445

ClinicalTrials.gov ID

NCT06787612

Key Eligibility
ClinicalTrials.gov

Contact
Name

Abrahm Levi

Email
Abrahm.Levi@cshs.org