Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
PCS6422 · 1 trial · 3 indications
Frequency, duration, and severity of DLTs and adverse events (AEs)
To evaluate the Maximum Plasma Concentration (Cmax) of capecitabine
| Arm | Type | Description |
|---|---|---|
| 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 is a commonly used oral fluoropyrimidine. |
Inclusion Criteria: 1. Has advanced, metastatic or unresectable GI tract tumors that are refractory or intolerant to existing available therapies and for whom the investigator recommends fluoropyrimidine monotherapy. 2. Has measurable disease in accordance with Respond Evaluation Criteria in Solid ...
Top 2 of 4 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| GE Healthcare Technologies Inc. | GEHC | 1 | PHASE1 | GEH200520/GEH200521 |
| Ascentage Pharma Group International Unsponsored ADR | AAPG | 1 | PHASE1 | Olverembatinib |
PCS6422 is being studied for use with capecitabine in patients with advanced, refractory cancers, including tumors of the gastrointestinal tract. It is an investigational small molecule developed by Processa Pharmaceuticals, Inc. (ticker PCSA) and has been tested in a Phase 1 clinical trial in adults with advanced cancer.
PCS6422 is being developed by Processa Pharmaceuticals, Inc., which trades under the ticker PCSA. The company sponsored the Phase 1 study of PCS6422 given with capecitabine in patients with advanced, refractory gastrointestinal tract tumors.
PCS6422 is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. The drug is investigational and has not been approved by the FDA for any indication.
PCS6422 has been evaluated in one completed Phase 1 trial, NCT04861987, titled a study of the safety and PK of PCS6422 (eniluracil) with capecitabine in patients with advanced, refractory GI tract tumors. The trial enrolled 23 participants in the United States and was uncontrolled, without randomization or blinding.
Yes. PCS6422 is also known as eniluracil, and it is studied in combination with capecitabine. The completed Phase 1 trial NCT04861987 is titled as a study of PCS6422 (eniluracil) with capecitabine in patients with advanced, refractory gastrointestinal tract tumors.
PCS6422 and capecitabine refers to the combination of PCS6422, also called eniluracil, with the chemotherapy agent capecitabine. This combination was tested in a completed Phase 1 trial, NCT04861987, in 23 adults with advanced, refractory gastrointestinal tract tumors in the United States.