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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PCS6422 and capecitabine is an investigational combination being studied for the treatment of advanced cancer and breast cancer. In clinical trials, it is being evaluated in patients with advanced, refractory gastrointestinal tract tumors and in patients with advanced or metastatic breast cancer, including triple-negative breast cancer and HER2-negative breast cancer.
PCS6422 and capecitabine is being developed by Processa Pharmaceuticals, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker symbol PCSA. The company is conducting clinical trials of this combination in the United States.
PCS6422 and capecitabine is in clinical development. A Phase 1 study of the combination in patients with advanced, refractory gastrointestinal tract tumors has been completed, and a Phase 2 study in patients with advanced or metastatic breast cancer is currently recruiting participants. The drug is investigational and not yet approved.
PCS6422 and capecitabine has been studied in two clinical trials. NCT04861987 was a completed Phase 1 study in patients with advanced, refractory GI tract tumors, enrolling 23 participants. NCT06568692 is a recruiting Phase 2 study in patients with advanced or metastatic breast cancer, with a planned enrollment of 90 participants.
Yes, PCS6422 is also known as eniluracil. The Phase 1 clinical trial NCT04861987 is titled 'A Study of the Safety and PK of PCS6422 (Eniluracil) with Capecitabine in Patients with Advanced, Refractory GI Tract Tumors,' confirming that PCS6422 and eniluracil refer to the same compound.