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Leptomeningeal Disease (LMD)Phase 1NCT07814352

A Study of SX-682 in Combination With Proton Craniospinal Irradiation (pCSI) in People With Leptomeningeal Disease

A Phase 1 study testing SX-682 and Proton Craniospinal Irradiation (pCSI) in people with Leptomeningeal Disease (LMD), run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Leptomeningeal Disease (LMD)
What is being tested?
SX-682 and Proton Craniospinal Irradiation (pCSI)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
7 sitesUnited States
Study dates
4 Sep 2026to Sep 2029
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 42Show fewer
  • 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)
  • Hemoglobin ≥ 8 g/dl (Note: use of transfusion or other intervention to achieve is acceptable)
  • o Adequate renal function is defined as follows:
  • Creatinine clearance (CrCL) of ≥30 mL/min by institutional standard (i.e. the Cockcroft-Gault formula or 24-hour urine collection)
  • o Adequate hepatic function is defined as follows:
  • Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) (patients with known Gilbert's disease who have bilirubin level ≤ 3 x ULN may be enrolled)
  • AST and ALT ≤3 x institutional ULN (patients with known liver mets ≤5 x institutional ULN)
  • o Adequate cardiac function is defined as follows: No history of unstable angina requiring hospitalization in the last 3 months;
  • No history of myocardial infarction within the last 3 months;
  • New York Heart Association Functional Classification II or better (NYHA Functional Classification III/IV are not eligible) (Note: Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification.)
  • Must be able to swallow pills
  • Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
  • Subjects with major medical, neurologic, or psychiatric condition who are judged as unable to fully comply with study therapy or assessments should not be enrolled.
  • For patients with known HIV, HBV, and/or HCV infection [HIV, HBV, and HCV testing do not need to be performed as part of the study; the below language provides guidelines for inclusivity of patients with known HIV, HBV, and/or HCV infection]:
  • HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.
  • For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.
  • Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.
  • The effects of proton CSI and CXCR1/2 inhibition on the developing human fetus are unknown. For this reason and because radiation as well as other therapeutic agents used in this trial are known to be teratogenic, participants of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) during study therapy and for 3 months following the completion of study therapy. Should a participant become pregnant or suspect pregnancy while participating in this study, they should inform their treating physician immediately.
  • Before enrollment, a women must be either:
  • Not of childbearing potential: premenarchal; postmenopausal (>45 years of age with amenorrhea for at least 12 months); permanently sterilized (e.g., bilateral tubal occlusion [which includes tubal ligation procedures as consistent with local regulations], hysterectomy, bilateral salpingectomy, bilateral oophorectomy); or otherwise be incapable of pregnancy
  • Of childbearing potential and practicing effective method(s) of birth control consistent with local regulations regarding the use of birth control methods for subjects participating in clinical studies, as described below:
  • Practicing true abstinence (when this is in line with the preferred and usual lifestyle of the subject), which is defined as refraining from heterosexual intercourse during the entire period of the study, including up to 6 months after the last dose of study drug is given. Periodic abstinence (calendar, symptothermal, post-ovulation methods) is not considered an acceptable contraceptive method
  • Have a sole partner who is vasectomized Practicing 2 methods of contraception, including one highly effective method (i.e., established use of oral, injected or implanted hormonal methods of contraception; placement of intrauterine device [IUD] or intrauterine system [IUS], AND, a second method (e.g., condom with spermicidal foam/gel/film/cream/suppository or collusive cap [diaphragm or cervical/vault caps] with spermicidal foam/gel/film/ cream/suppository)
  • Subjects must agree to continue contraception throughout the study and continuing through 6 months after the last dose of study drug
  • NOTE: If the childbearing potential changes after start of the study (e.g., woman who is not heterosexually active becomes active, premenarchal woman experiences menarche) the woman must begin a highly effective method of birth control, as described above.
  • A woman of childbearing potential must have a negative serum (b-human chorionic gonadotropin [b-hCG]) at Screening
  • A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for 6 months after receiving the last dose of study drug
  • A man who is sexually active with a woman of childbearing potential must agree to use a condom with spermicidal foam/gel/film/cream/suppository and his partner must also be practicing a highly effective method of contraception (i.e., established use of oral, injected or implanted hormonal methods of contraception; placement of an intrauterine device [IUD] or intrauterine system [IUS]). If the subject is vasectomized, he must still use a condom (with or without spermicide), but his female partner is not required to use contraception. The subject must also not donate sperm during the study and for 6 months after receiving the last dose of study drug

Who cannot join

  • 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

Trial locations and contacts

7 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Monica Chen, MD contact

646-888-5108

chenm9@mskcc.org

Yao Yu, MD contact

908-542-3427

7 sites in 1 country

United States7 sites, 7 recruiting

  • Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

    Basking Ridge, New Jersey, 07920

    Monica Chen, MD, 646-888-5108

    Recruiting

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

    Commack, New York, 11725

    Monica Chen, MD, 646-888-5108

    Recruiting

  • Memorial Sloan Kettering Commack (Limited Protocol Activities)

    Commack, New York, 11725

    Monica Chen, MD, 646-888-5108

    Recruiting

  • Memorial Sloan Kettering Westchester (Limited Protocol Activities)

    Harrison, New York, 10604

    Monica Chen, MD, 646-888-5108

    Recruiting

  • Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

    Middletown, New Jersey, 07748

    Monica Chen, MD, 646-888-5108

    Recruiting

  • Memorial Sloan Kettering Bergen (Limited Protocol Activities)

    Montvale, New Jersey, 07645

    Monica Chen, MD, 646-888-5108

    Recruiting

  • Memorial Sloan Kettering Nassau (Limited Protocol Activities)

    Uniondale, New York, 11553

    Monica Fornier, MD, 646-888-4563

    Recruiting

Other trials in United States

About this study

Official title: A Phase Ib Trial of SX-682 (CXCR1/2 Inhibitor) Combined With Proton Craniospinal Irradiation for Patients With Leptomeningeal Disease

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.

Being tested
SX-682, Proton Craniospinal Irradiation (pCSI)
Keywords
Proton Craniospinal Irradiation, SX-682
Medical subject headings
Meningeal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

  • Proton Craniospinal Irradiation (pCSI)Radiation

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

Study groups in NCT07814352
Study groupRoleWhat they receive
SX-682 (CXCR1/2 inhibitor) Combined with Proton Craniospinal IrradiationExperimentalPatients 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.
Receives: Drug: SX-682; Radiation: Proton Craniospinal Irradiation (pCSI)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence, severity, and type of adverse event

    will be graded per CTCAE v 6.0

    Measured: 3 years

Secondary outcomes (1)

  1. Overall survival (OS)

    OS will be defined as the time from initiation of SX-682 to death from any cause. Patients alive at last follow-up will be censored at that date.

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Sep 2026
  2. Study start4 Sep 2026
  3. Primary completionSep 2029 (estimated)
  4. Study completionSep 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Single-arm, prospective trial
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07814352
Sponsor's protocol ID
26-263
Status last verified
Sep 2026
First submitted
4 Sep 2026
Last updated
11 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing SX-682 and Proton Craniospinal Irradiation (pCSI) in people with Leptomeningeal Disease (LMD), run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 42 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Monica Chen, MD (646-888-5108, chenm9@mskcc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence, severity, and type of adverse event (time frame: 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07814352.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.

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