Phase II Trial of Ubamatamab Alone or in Combination With Cemiplimab in MUC16-Expressing SMARCB1-Deficient Malignancies

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT06444880
Phase
PHASE2
Status
Recruiting
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Conditions

  • Epithelioid Sarcoma
  • Medullary Carcinoma
  • SMARCB1-Deficient Malignancies

Eligibility Criteria

Sex
ALL
Age
12 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ubamatamab — DRUG
    Given by IV
  • Cemiplimab — DRUG
    Given by IV

Study Details

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).

Key Dates

Start date
Oct 9, 2024
Status verified
Jan 2026
Primary completion
Jul 31, 2028
Completion
Jul 31, 2028

Study Design

Enrollment
40 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Stage I
    Stage 1 of study treatment involves being given ubamatamab by itself by vein. The first dose will be given over about 4 hours. Depending on how participants respond, later doses may be given over shorter periods of time (possibly down to 30 minutes per infusion). Participants dose of ubamatamab will be increased from a starting dose on Day 1 to a full dose on Day 15. Participants will receive ubamatamab 1 time every week for the first 4 weeks, then every 3 weeks after that, unless the disease gets worse or intolerable side effects occur. • If the disease gets worse after completing 6 weeks of treatment, participants will move to Stage 2 and receive combination therapy.
  • Experimental: Stage 2
    Participants in Stage 2 will begin receiving ubamatamab and cemiplimab. * If participants are enrolled directly into Stage 2, but did not have therapy with ubamatamab alone, participants will receive ubamatamab 1 time each week for 4 weeks, before beginning combination therapy. * If participants have already completed Stage 1 and are moving on to Stage 2, participants will begin with combination therapy. During Stage 2, ubamatamab is given by vein over 30 minutes to 4 hours, as described above. Cemiplimab is given by vein over 30 minutes.

Primary Outcome Measure

Safety and adverse events (AEs) [ Time Frame: Through study completion; an average of 1 year. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
MD Anderson Cancer CenterHoustonTexas77030
Pavlos Msaouel, MD,PHD,PHD
[email protected]
713-563-4585
Pavlos Msaouel, MD,PHD,PHD (PRINCIPAL_INVESTIGATOR)

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By research site
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