Actively Recruiting
Phase II Trial of Ubamatamab Alone or in Combination With Cemiplimab in MUC16-Expressing SMARCB1-Deficient Malignancies
Led by M.D. Anderson Cancer Center · Updated on 2026-01-08
40
Participants Needed
1
Research Sites
198 weeks
Total Duration
On this page
Sponsors
M
M.D. Anderson Cancer Center
Lead Sponsor
R
Regeneron Pharmaceuticals
Collaborating Sponsor
AI-Summary
What this Trial Is About
To find out if ubamatamab, given by itself or in combination with cemiplimab, can help to control the disease in participants with renal medullary carcinoma (RMC) and epithelioid sarcoma (ES).
CONDITIONS
Official Title
Phase II Trial of Ubamatamab Alone or in Combination With Cemiplimab in MUC16-Expressing SMARCB1-Deficient Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must have locally advanced or metastatic renal medullary carcinoma (RMC) or epithelioid sarcoma (ES) confirmed by expert pathology review and loss of SMARCB1 staining.
- Participants may have unclassified renal cell carcinoma with medullary phenotype for the RMC cohort.
- Participants must show serum CA-125 levels ≥ 70 units/ml or MUC16 expression with H score > 25 within 12 months prior to screening.
- Participants must have at least one measurable disease site with lesions ≥ 15 mm by conventional methods or ≥ 10 mm by sensitive imaging.
- Participants must have progressed on at least one prior therapy and show disease progression after last treatment.
- Participants must have ECOG performance status 0-1 (ambulatory, including wheelchair mobility).
- Participants must be 18 years or older, with possible inclusion of adolescents ≥ 12 years old weighing over 40 kg after interim safety review.
- Participants must consent to companion laboratory protocols.
- Participants must have adequate organ and marrow function as defined by specific blood counts and liver and kidney function tests.
- Participants with controlled brain metastases without recurrence or edema for at least 4 weeks are eligible.
- Women of childbearing potential must have a negative pregnancy test and agree to contraception.
- Women must not be breastfeeding.
- Participants must be willing and able to provide informed consent.
You will not qualify if you...
- Participants with other malignancies within 2 years except certain in situ or treated cancers.
- Prior treatment with T-cell-redirecting bispecific antibodies or MUC16-targeted therapies; recent CAR-T therapy within 30 days.
- Receiving anticancer therapies within 14 days before study start.
- Persistent grade ≥ 2 adverse events from prior therapies that interfere with study.
- Recent major surgery or significant injury within 28 days before study start.
- Organ transplant recipients.
- Known or suspected autoimmune diseases except certain mild or controlled autoimmune conditions.
- Uncontrolled infections including HIV, hepatitis B or C, or immunodeficiency.
- Medical conditions that may interfere with study or pose risks, including active COVID-19 infection.
- Concurrent participation in other experimental drug studies.
- Use of high-dose steroids or potent immune suppressants beyond allowed exceptions.
- Significant heart conditions, including low ejection fraction, myocarditis, pericardial effusion, or arrhythmias.
- Severe or uncontrolled medical or psychiatric conditions limiting study participation.
- Immunization with live vaccines within 30 days before study drug start.
- Pregnant or breastfeeding women or those unwilling to use contraception.
- History of allergic reactions to ubamatamab or cemiplimab or related compounds.
- Psychiatric or social situations limiting compliance with study requirements.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
P
Pavlos Msaouel, MD,PHD,PHD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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