Nirogacestat in Patients With Kaposi Sarcoma

Conditions

• AIDS-Related Kaposi Sarcoma
• Skin Kaposi Sarcoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Biospecimen Collection — PROCEDURE
  Undergo collection of blood
• Chest Radiography — PROCEDURE
  Undergo chest X-ray
• Computed Tomography — PROCEDURE
  Undergo CT
• Nirogacestat — DRUG
  Given PO
• Skin Biopsy — PROCEDURE
  Undergo skin biopsy

Study Details

This phase II trial studies how well nirogacestat works in treating patients with skin Kaposi sarcoma (KS). Several anti-cancer drugs work well in treating KS, but there is no treatment that cures KS. Nirogacestat binds to a protein called gamma secretase, which blocks the activation of other proteins called Notch receptors. Blocking these proteins may help keep tumor cells from growing and may kill them. Nirogacestat is a type of gamma secretase inhibitor. Nirogacestat may be effective in shrinking the size of KS lesions and reducing the spread of lesions.

Key Dates

Start date

Sep 17, 2026

Status verified

May 2026

Primary completion

Feb 17, 2030

Completion

Feb 17, 2030

Study Design

Enrollment

28 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Treatment (nirogacestat)
  Patients receive nirogacestat PO BID on days 1-28 of each cycle. Cycles repeat every 28 days for 12 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo skin biopsy and chest X-ray during screening as well as blood sample collection throughout the study. Patients may also undergo an additional optional skin biopsy on study and CT throughout the study.

Primary Outcome Measure

Overall response rate (ORR) [ Time Frame: Up to 5 years after completion of study treatment ]

Locations (1)

Find similar trials in St Louis, MO