Clinical trial · Interventional
RAPID: Phase 2 Platform Trial Of Promising Drugs For AYA Patients With R/R Ewing Sarcoma & DSRCT
Rapid Advancement Of Promising Innovative Drugs (RAPID): A Patient-Centric, Investigator-Initiated, Bayesian, Multi-Center, Open-Label, Phase 2 Platform Trial Of Promising Drugs For AYA Patients With Relapsed/Refractory Ewing Sarcoma & DSRCT
NCT07781891CI-TRIAL-00123470not yet recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The goal of this clinical research study is to learn if new anticancer drugs or drug combinations can help to control relapsed/refractory ES, DSRCT, or SRCS.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ewing Sarcoma | Ewing Sarcoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| LX-101 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment with LX-101
- description
- Participants will be enrolled into one of three cohorts based on their sarcoma subtype. Relapsed/refractory ES or DSRCT are assigned to receive one of several predetermined cohort-specific investigational therapies.
- interventionNames
- Drug: LX-101
Primary outcomes (1)
- measure
- Safety and Adverse Events (AEs)
- timeFrame
- Through study completion; an average of 1 year.
- description
- Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 10 Years
Show eligibility criteria text
Inclusion Criteria: Eligibility Criteria A. Age ≥ 10 years (Safety data from ≥3 adult patients must exist before enrolling children). B. Must have relapsed or chemo-refractory ES, DSRCT, or SRCS. C. Must have received at least 2 prior chemotherapy regimens (typically VIDE or VDC/IE) D. Measurable disease by RECIST (i.e., tumor ≥1 cm in minimal dimension) E. ECOG performance status is 0-2 for adults (Karnofsky/Lansky score ≥60 for children \<16 years of age) F. \>1 week washout period from any investigational agent and resolution of drug-related AE/SAE to ≤ grade 2. Exclusion Criteria: A. Uncontrolled or severe cardiac, neurologic, pulmonary, pancreatic, renal, or liver disease. B. No known personal family history of Long QT syndrome C. History of organ transplant (other than autologous stem cell transplant for cancer), active pneumonitis, myelodysplastic syndrome, or leukemia (acute or chronic) D. Immune or auto-immune-related disorders requiring treatment (treatment for eczema is allowed) E. Investigational agents within 7 days of starting study treatment. F. Major surgery within 28 days before treatment consent (Treatment cannot start with a persistent open wound) G. Leptomeningeal disease or untreated brain metastases. H. Unable to safely hold anticoagulant medication, if taken, for biopsy. I. Psychiatric illness/social situations that would limit compliance with study requirements. J. Prisoners or participants who are legally institutionalized.
References
Publications (0)
Data not yet available
No reference posted for this study.