NCT07438626

Phase II Trial of Sacituzumab Tirumotecan in Patients With SMARCB1-Deficient Renal Medullary Carcinoma

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To learn if sacituzumab tirumotecan can help to control advanced or metastatic SMARCB1-deficient RMC in patients whose disease has progressed after receiving at least 1 treatment.

Detailed description

Primary Objectives To determine the objective response rate (ORR) at any time and disease control rate (DCR) through 18 weeks from treatment initiation, as assessed by independent reviewer per RECIST 1.1, of sacituzumab tirumotecan in participants with locally advanced or metastatic SMARCB1-deficient RMC who have progressed on at least one prior line of therapy. Secondary Objectives To determine the efficacy and safety of sacituzumab tirumotecan in participants with locally advanced or metastatic SMARCB1-deficient RMC who have progressed on at least one prior line of therapy. Efficacy will be measured by overall survival (OS), progression-free survival (PFS), and duration of response (DOR).

Conditions

• Phase II
• Sacituzumab
• Tirumotecan
• SMARCB1-deficient Renal Medullary Carcinoma

Interventions

Type	Name	Description
DRUG	Sacituzumab tirumotecan	Given by IV

Timeline

• Start date: 2026-06-01
• Primary completion: 2028-06-01
• Completion: 2030-02-01
• First posted: 2026-02-27
• Last updated: 2026-03-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study