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NCT06444880

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

StatusRecruiting
PhasePhase 2
Primary completion (estimated)
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Record History

All 19 versions: 10 with changes below, 9 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Notable Enrollment reopened
    • Enrollment increased: 15 → 40 participants
    • Site details revised
  2. Notable Eligibility criteria expanded, about 38 words
    • Publications: details revised at 1 of 1 entry
    • Study description expanded, about 2 words
  3. Notable Enrollment reduced: 40 → 15 participants
    • Primary completion moved earlier from Jul 31, 2028 to Jul 31, 2027
    • Enrollment closed, study ongoing
    • Site details revised
    v17
  4. Minor Site contact updatedv13
  5. Minor Site contact updatedv12
Show 4 earlier versionsHide 4 earlier versions
  1. Minor Site contact updatedv9
  2. Minor Site contact updatedv8
  3. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Nov 29, 2024 to Oct 9, 2024
    • Site details revised
    v5
  4. Notable Primary completion date: Jul 31, 2026 to Jul 31, 2028v2
  1. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Safety and adverse events (AEs)
Timeframe: Through study completion; an average of 1 year.

Arms and interventions

Stage IExperimental

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.

Stage 2Experimental

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.

Drugs: Ubamatamab, Cemiplimab

Sites

1 site in 1 country

  • MD Anderson Cancer CenterHouston, Texas, United States