Lurbinectedin in FET-Fused Tumors (NCT05918640) | Clinical Trial Compass
RecruitingPhase 1/2
Lurbinectedin in FET-Fused Tumors
United States63 participantsStarted 2023-07-27
Plain-language summary
The purpose of this study is to find out if a drug called lurbinectedin (the "study drug") is safe and effective at treating people with recurrent or relapsed solid tumors, including Ewing sarcoma.
Who can participate
Age range10 Years
SexALL
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Inclusion criteria
✓. Age ≥ 10 years.
✓. Phase 1: Histological confirmed diagnosis of recurrent or relapsed solid tumor failing primary therapy. Patients must have a known FET fusion (fusion that contains EWSR1, FUS, or TAF15) as documented by next generation sequencing, polymerase chain reaction (PCR) or Fluorescence in situ hybridization (FISH). Patients with a histological diagnosis of Ewing sarcoma with EWS-FLI1 are eligible for dose escalation but not for the exploratory cohort. Please note patients with Ewing sarcoma and alternative FET-ETS fusions (including but not limited to EWS-ERG, EWS-ETV1, EWS-ETV4, EWS-FEV, FUS-ERG, FUS-FEV) are eligible for the exploratory cohort.
✓. Phase 2: Histologically confirmed diagnosis of recurrent or relapsed Ewing sarcoma failing primary therapy with confirmation of EWS-FLI1 fusion and breakpoint by Next generation sequencing or PCR or EWSR1 rearrangement confirmed by FISH and available tissue for central confirmation of EWS-FLI1 fusion and breakpoint.
✓. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 (age \>16 years) or Lansky of at least 70 (age \<16 years).
✓. Disease status (baseline imaging must be performed within 28 days of Day 1 of study treatment):
✓. Phase 1: At least one site of measurable disease on CT or MRI as defined by RECIST 1.1 OR evaluable disease with at least one site of disease that has not been previously radiated
✓. Phase 2: At least one site of measurable disease on CT or MRI as defined by RECIST 1.1
✓. Meets organ function requirements as outlined below:
Exclusion criteria
✕
What they're measuring
1
Phase 1: Dose Limiting Toxicities (DLTs)
Timeframe: within 28 days of the first dose
2
Phase 1: Frequency of adverse events
Timeframe: 28 days after last dose
3
Phase 1: Complete Response or Partial Response
Timeframe: through the end of treatment, an average of 1 year