NCT07814352

Brief Summary

The researchers are doing this study to find out whether SX-682 in combination with proton craniospinal irradiation (pCSI) is a safe treatment approach for people with melanoma or non-small cell lung cancer (NSCLC) with leptomeningeal disease (LMD). The researchers will also look at whether the treatment combination is effective against participants' cancer.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
35mo left

Started Sep 2026

Typical duration for phase_1

Geographic Reach
1 country

7 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress3%
Sep 2026Sep 2029

First Submitted

Initial submission to the registry

September 4, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

September 4, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 11, 2026

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2029

Last Updated

September 11, 2026

Status Verified

September 1, 2026

Enrollment Period

3 years

First QC Date

September 4, 2026

Last Update Submit

September 4, 2026

Conditions

Leptomeningeal Disease (LMD)

Keywords

Proton Craniospinal IrradiationSX-682

Outcome Measures

Primary Outcomes (1)

  • Incidence, severity, and type of adverse event

    will be graded per CTCAE v 6.0

    3 years

Secondary Outcomes (1)

  • Overall survival (OS)

    3 years

Study Arms (1)

SX-682 (CXCR1/2 inhibitor) Combined with Proton Craniospinal Irradiation

EXPERIMENTAL

Patients will receive SX-682 200 mg by mouth twice a day up to cycle 3. The total prescribed dose will be 30Gy (RBE) in 3Gy (RBE) daily fractions.

Drug: SX-682Radiation: Proton Craniospinal Irradiation (pCSI)

Interventions

SX-682DRUG

Patients will receive SX-682 200 mg by mouth twice a day up to cycle 3. Subsequently, all patients will receive systemic therapy of the investigator's choice.

SX-682 (CXCR1/2 inhibitor) Combined with Proton Craniospinal Irradiation
Proton Craniospinal Irradiation (pCSI)RADIATION

The total prescribed dose will be 30Gy (RBE) in 3Gy (RBE) daily fractions.

SX-682 (CXCR1/2 inhibitor) Combined with Proton Craniospinal Irradiation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 18
  • Written informed consent
  • ECOG 0-2
  • Patients must have radiographic and/or pathologically confirmed leptomeningeal metastasis established through at least one of the following:
  • Positive CSF cytology for malignancy and/or positive CSF circulating tumor cells
  • CSF cytology with suspicious cells is considered positive; CSF cytology with atypical cells is considered equivocal and not positive
  • Unequivocal radiographic diagnosis of leptomeningeal metastasis on contrast- enhanced MRI
  • Patients may receive steroids to control symptoms related to CNS involvement, but the dose must be \<= 8 mg per 24 hours of dexamethasone (or the equivalent). Patient's symptoms should experience stability of neurological symptoms for at least 7 days, or on a tapering dose of steroids Patients must have a confirmed pathological diagnosis of a metastatic or recurrent melanoma or non-small cell lung cancer
  • Patients will have progressed on standard of care therapies
  • Patients who have been treated with an approved oral targeted therapy (i.e. BRAF/MEKi, EGFR TKI, etc) will be allowed to remain on concurrent approved targeted therapy up until the start of the trial, with no washout
  • Washout for all other systemic treatment (i.e., chemotherapy, immunotherapy, VEGF): 14 days
  • Required Organ Function
  • o Adequate hematologic function is defined as follows:
  • Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3
  • Platelets ≥ 100,000 cells/mm3 (Note: use of transfusion or other intervention to achieve is acceptable)
  • +27 more criteria

You may not qualify if:

  • Patient who is unable to undergo MRI brain and spine with gadolinium contrast
  • Previous radiotherapy to the intended treatment site that precludes developing a treatment plan that respects normal tissue tolerances
  • Multiple, serious neurologic deficits, including encephalopathy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, 07920, United States

RECRUITING

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Middletown, New Jersey, 07748, United States

RECRUITING

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, New Jersey, 07645, United States

RECRUITING

Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Limited protocol activities)

Commack, New York, 11725, United States

RECRUITING

Memorial Sloan Kettering Commack (Limited Protocol Activities)

Commack, New York, 11725, United States

RECRUITING

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Harrison, New York, 10604, United States

RECRUITING

Memorial Sloan Kettering Nassau (Limited Protocol Activities)

Uniondale, New York, 11553, United States

RECRUITING

Related Links

MeSH Terms

Conditions

Meningeal Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsNervous System Diseases

Study Officials

  • Monica Chen, MD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Monica Chen, MD

CONTACT

646-888-5108chenm9@mskcc.org

Yao Yu, MD

CONTACT

908-542-3427

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Single-arm, prospective trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 4, 2026

First Posted

September 11, 2026

Study Start

September 4, 2026

Primary Completion (Estimated)

September 1, 2029

Study Completion (Estimated)

September 1, 2029

Last Updated

September 11, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will share

Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Locations

US(7)