drugset / Trial / NCT04997993

Leflunomide in Patients With PTEN-Altered Advanced Solid Malignancies and HER2 Negative Breast Cancer

NCT04997993

Phase 1 Recruiting 23 enrolled Deborah Doroshow
NaSingle-groupOpen-labelTreatment

Summary

Leflunomide in patients with PTEN-Altered advanced solid tumors or HER2 negative breast cancer. Phase 1A objectives are to determine the safety, tolerability, and the MTD of leflunomide in patients with PTEN-Altered advanced solid malignancies and HER2 negative breast cancer. Phase 1B objective is to assess preliminary evidence of clinical activity of leflunomide in these patient populations.

Timeline

Start
2023-12-13
Primary completion
2027-07
Completion
2028-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Leflunomide Small molecule 20 mg Oral
Subject Leflunomide Small molecule 50 mg Oral