Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06568692 | A Phase 2 Study of PCS6422 With Capecitabine in Patients With Advanced or Metastatic Breast Cancer | PHASE2 | RECRUITING | 90 | — | — | Oct 2, 2024 | Oct 1, 2026 | Jun 19, 2025 | 13 | United States |
The proportion of patients who achieved a confirmed complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1)
Frequency, duration, and severity of AEs across treatment groups
| Arm | Type | Description |
|---|---|---|
| PCS6422 40 mg + Capecitabine 300 mg | EXPERIMENTAL | Fixed single dose of PCS6422 administered with Capecitabine 150 mg BID over 7 days |
| PCS6422 40 mg + Capecitabine 450 mg or 150 mg | EXPERIMENTAL | Fixed single dose of PCS6422 administered with Capecitabine 225 mg or 75 mg BID over 7 days |
| Capecitabine 2000 mg/m2 | ACTIVE_COMPARATOR | Standard capecitabine dose at 1000 mg/m2 BID |
| Name | Type | Description |
|---|---|---|
| PCS6422 and capecitabine | DRUG | PCS6422 is an experimental drug that, when combined with capecitabine, may make the immune response more active against cancer. |
| Capecitabine | DRUG | Commercially available capecitabine is a commonly used oral fluoropyrimidine. |
Inclusion Criteria: 1. Aged ≥18 years at Screening 2. Diagnosis of histologically confirmed breast cancer that is unresectable. The following subsets of breast cancer are included: 1. Patients with triple-negative breast cancer, advanced or metastatic 2. Patients with hormone receptor (HR) p...