Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
PCS6422 and capecitabine · 2 trials · 6 indications
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
Frequency, duration, and severity of DLTs and adverse events (AEs)
To evaluate the Maximum Plasma Concentration (Cmax) of capecitabine
| 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 |
| PCS6422 + Capecitabine | EXPERIMENTAL | Fixed dose of PCS6422 combined with various doses of Capecitabine administered in 14 day cycles |
| 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...
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