Drugs / PCS6422
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT04861987 | Jun 2021 → Jun 2024 | cancer of unknown primary site, gastric neoplasm, refractory malignant neoplasm | Processa Pharmaceuticals | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT06568692 | Oct 2024 → Sep 2026 overdue | triple-negative breast carcinoma | Processa Pharmaceuticals | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 11
| Date | Issuer | Release |
|---|---|---|
| 2025-12-17 | Processa Pharmaceuticals | Results Processa Pharmaceuticals Provides Clinical Update on Phase 2 Study in Metastatic Breast Cancer processapharmaceuticals.com ↗
Data from the first 16 of 19 patients enrolled indicate that NGC-Cap significantly increases exposure to capecitabine cancer-killing drug metabolites without increasing the severity of side effects compared to standard monotherapy capecitabine therapy (Mono-Cap). |
| 2025-05-30 | Processa Pharmaceuticals | Results Processa Pharmaceuticals Announces Presentation and Publication of Three Abstracts at 2025 ASCO Annual Meeting processapharmaceuticals.com ↗
This online-only abstract provides data from the Phase 1b study that defined the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose Range (RP2DR) for NGC-Cap (eniluracil + capecitabine or 6422 + Cap), highlighting its improved safety profile and anti-tumor activity compared to standard capecitabine. |
| 2024-07-30 | Processa Pharmaceuticals | Regulatory Processa Pharmaceuticals Announces FDA Clearance of IND Application for a Phase 2 Clinical Trial of NGC-Cap in Breast Cancer processapharmaceuticals.com ↗
Processa Pharmaceuticals, Inc. (Nasdaq: PCSA) (Processa or the Company), a clinical-stage pharmaceutical company focused on developing the next generation of chemotherapeutic drugs with improved efficacy and safety, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) application for Next Generation Capecitabine (NGC-Cap), its lead product candidate. |
| 2024-06-11 | Processa Pharmaceuticals | Results Processa Pharmaceuticals Announces Positive Efficacy Results from Preliminary Evaluation of Phase 1b Dose-escalating Trial with NGC-Cap in Gastrointestinal Cancer processapharmaceuticals.com ↗
At the highest NGC-Cap dose, all three evaluable patients had PFS with two partial responses (PR) and one stable disease (SD) |
| 2024-04-11 | Processa Pharmaceuticals | Results Processa Pharmaceuticals Presents Two Abstracts at the AACR Annual Meeting 2024 Including New Data on the NGC-Cap Phase 1b Trial processapharmaceuticals.com ↗
NGC-Cap demonstrated greater 5-FU (5-fluorouracil) exposure and lower fluoro-beta-alanine (FBAL) exposure with a better or similar side effect profile compared with monotherapy capecitabine. |
| 2024-01-25 | Processa Pharmaceuticals | Results Processa Pharmaceuticals Announces Successful Completion of Phase 1b Safety Evaluation of NGC-Cap in Patients with Advanced Cancer Resulting in Recommended Phase 2 Doses processapharmaceuticals.com ↗
From the Phase 1b data, two dosage regimens have been selected for the Phase 2 trial. |
| 2023-12-19 | Processa Pharmaceuticals | Results Processa Pharmaceuticals Provides Interim Analysis from Ongoing Phase 1b Trial of Next Generation Capecitabine Showing Improved Safety Over Capecitabine processapharmaceuticals.com ↗
These initial data provide our first confirmatory clinical evidence that NGC-Cap is metabolized differently than capecitabine and, as a result, may offer significant improvements in safety and efficacy over capecitabine, a commonly used chemotherapeutic agent across multiple cancer indications. |
| 2023-08-17 | Processa Pharmaceuticals | Results Processa Pharmaceuticals Provides Data Update Supporting a Potential Personalized Treatment Approach for Improved Cancer Care processapharmaceuticals.com ↗
Processa has found that regularly measuring the concentrations of DPD, as expressed by the metabolite FBAL, may provide a method to better understand how each patient responds to different NGC-Cap dosage regimens. |
| 2022-11-08 | Processa Pharmaceuticals | Results Processa Pharmaceuticals Announces Third Quarter Financial Results and Provides Corporate Update processapharmaceuticals.com ↗
We are delighted to report our push to enroll patients in PCS12852 (Gastroparesis) and PCS6422 (Next Generation Capecitabine) has helped us get critical data and report successful preliminary results in both trials. |
| 2022-11-01 | Processa Pharmaceuticals | Results Processa Successfully Identifies Next Generation Capecitabine Dosage Regimens for Phase 2B Trial processapharmaceuticals.com ↗
NGC regimens (i.e., a variety of PCS6422 regimens combined with a variety of capecitabine regimens) were also identified that are safe with different systemic and tumor exposure profiles to 5-FU. |
| 2021-11-04 | Processa Pharmaceuticals | Results Processa Pharmaceuticals Announces Next Generation Capecitabine (Combination of PCS6422 and Capecitabine) Inhibits DPD in Phase 1b Interim Analysis processapharmaceuticals.com ↗
Next Generation Capecitabine inhibited DPD activity 24-48 hours after PCS6422 administration with < 10 % of 5-FU metabolized to FBAL compared to 80% reported for FDA approved capecitabine . |
All press releases naming this drug 14 releases
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | PCS6422 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04861987 ↗ |
| Known as | Eniluracil | “A Study of the Safety and PK of PCS6422 (Eniluracil) with Capecitabine in Patients with Advanced, Refractory GI Tract Tumors” NCT04861987 ↗ |