drugset / Trial / NCT06568692
A Phase 2 Study of PCS6422 With Capecitabine in Patients With Advanced or Metastatic Breast Cancer
RandomizedParallel-groupOpen-labelTreatment
Summary
This is an adaptive Phase 2, open-label, randomized, multi-center study evaluating up to 2 regimens of PCS6422 with capecitabine (Cap) vs. standard dose of Cap alone in patients with advanced or metastatic breast cancer. The goal of the study is to assess the efficacy and safety of PCS6422 + Cap as a treatment option for patients with advanced or metastatic breast cancer who are not eligible for anthracycline- or taxane-containing therapies, or other available therapies, including PD-1 or PARP inhibitors.
Timeline
- Start
- 2024-10-02
- Primary completion
- 2026-09
- Completion
- 2026-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Capecitabine | Small molecule | 75 mg | Oral |
| Subject | Capecitabine | Small molecule | 150 mg | Oral |
| Subject | Capecitabine | Small molecule | 225 mg | Oral |
| Subject | Capecitabine | Small molecule | 1000 mg/m2 | Oral |
| Subject | PCS6422 | Unknown | 40 mg | — |