Phase II Study of Ubamatamab Alone or with Cemiplimab for MUC16-Expressing SMARCB1-Deficient Cancers

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0

ClinicalTrials ID:NCT06444880

Provider View

This clinical trial is exploring whether the drug ubamatamab, either by itself or combined with cemiplimab, can help manage renal medullary carcinoma (RMC) and epithelioid sarcoma (ES) in patients whose cancer has progressed after previous treatments.

Patient Parameters

Program Overview

The study aims to find out if ubamatamab, alone or with cemiplimab, can effectively control cancer in patients with advanced or metastatic MUC16-expressing SMARCB1-deficient cancers, specifically renal medullary carcinoma (RMC) or epithelioid sarcoma (ES). Researchers will measure how well the treatment works by looking at the response rate and disease control rate, as well as overall survival, progression-free survival, and how long the response lasts. The study will also explore potential biomarkers to better understand how the treatment works and why some patients may not respond.

Description

This trial is testing the effectiveness of ubamatamab, alone or with cemiplimab, in treating certain advanced cancers that express the MUC16 protein and lack the SMARCB1 gene. The main goal is to see how many patients experience a reduction in tumor size or disease stabilization. Researchers will also assess the safety of the treatment and how long patients live without the disease getting worse. The study will explore how the treatment affects cancer cells and identify any markers that might predict treatment success or resistance. Participants will be monitored for side effects and overall health throughout the study.

Eligibility Criteria

Inclusion Criteria

  • Have advanced or metastatic renal medullary carcinoma (RMC) or epithelioid sarcoma (ES) confirmed by pathology.
  • Show specific levels of the MUC16 protein in blood or tumor tissue.
  • Have at least one measurable tumor that can be tracked by scans.
  • Have tried at least one previous cancer treatment.
  • Be in good general health, able to perform daily activities with minimal assistance.
  • Be 18 years or older, with potential inclusion of adolescents aged 12 and older if certain safety criteria are met.
  • Agree to provide a tumor sample for research purposes.
  • Have adequate blood counts and organ function.
  • If there are brain metastases, they must be treated and stable.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective birth control during and after the study.
  • Men must agree to use effective birth control during and after the study.
  • Be willing to sign a consent form and follow study procedures.

Exclusion Criteria

  • Have had another cancer within the past 2 years, except for certain skin or cervical cancers.
  • Have received certain types of cancer treatments recently, such as T-cell therapies or MUC16-targeted therapies.
  • Have ongoing side effects from previous cancer treatments that could interfere with the study.
  • Have had major surgery or significant injury recently.
  • Have organ transplants or autoimmune diseases that are not well-controlled.
  • Have uncontrolled infections like HIV, hepatitis B, or hepatitis C.
  • Have any medical condition that could make the study treatment unsafe or difficult to interpret.
  • Be pregnant or breastfeeding, or not willing to use birth control.
  • Have a history of severe allergic reactions to similar drugs.
  • Be unable to comply with study visits and procedures.

Locations

FACILITYZIPCITYSTATE
MD Anderson Cancer Center77030HoustonTexas

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