RAPID: Phase 2 Platform Trial Of Promising Drugs For AYA Patients With R/R Ewing Sarcoma & DSRCT

NCT07781891 | Not Yet Recruiting Phase 2 FDA Drug

• 2 other identifiers: 2024-1944NCI-2026-06305
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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

Ewing Sarcoma

Keywords

Relapsed; Refractory

Outcome Measures

Primary Outcomes (1)

• Safety and Adverse Events (AEs)

  Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

  Through study completion; an average of 1 year.

Study Arms (1)

Treatment with LX-101

EXPERIMENTAL

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.

Drug: LX-101

Interventions

LX-101 DRUG

Given by injection

Treatment with LX-101

Eligibility Criteria

• Age: 10 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

MD Anderson Cancer Center

Houston, Texas, 77090, United States

Location

Related Links

• UT MD Anderson Website

MeSH Terms

Conditions

Sarcoma, Ewing; Recurrence

Condition Hierarchy (Ancestors)

Osteosarcoma; Neoplasms, Bone Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Joseph Ludwig, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joseph Ludwig, MD

CONTACT

(713) 792-3626; jaludwig@mdanderson.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2026
• First Posted: August 24, 2026
• Study Start (Estimated): February 1, 2027
• Primary Completion (Estimated): June 30, 2031
• Study Completion (Estimated): June 30, 2033
• Last Updated: August 24, 2026

Record last verified: 2026-08

Locations

US (1)