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

Conditions

• Leptomeningeal Disease (LMD)

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• SX-682 — DRUG
  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 Details

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.

Key Dates

First listed

Sep 11, 2026

Start date

Sep 4, 2026

Status verified

Sep 2026

Primary completion

Sep 30, 2029

Completion

Sep 30, 2029

Study Design

Enrollment

40 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: SX-682 (CXCR1/2 inhibitor) Combined with Proton Craniospinal Irradiation
  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.

Primary Outcome Measure

Incidence, severity, and type of adverse event [ Time Frame: 3 years ]

Central Contacts

• Monica Chen, MD
  646-888-5108
  [email protected]
• Yao Yu, MD
  908-542-3427

Locations (7)

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