Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
RX-3117 · 2 trials · 3 indications
Number of participants who experienced a treatment-related adverse event
Participants with adverse events coded using the MedDRA Dictionary (Version 20.0) to Investigations. Due to the underlying disease, not all abnormal labs are reported.
Number of participants with clinically significant vital sign abnormalities (Phase 1 and 2) including heart rate, respiration rate, and blood pressure
Number of participants with clinically significant ECG abnormalities (Phase 1 and 2)
Participants must have progression Free Survival (PFS) \> 4 months or objective clinical response (complete or partial response).
Number of subjects participating in Phase 1 that experienced a DLT during the first cycle of treatment (28 days)
Number of subjects participating in Phase 1 that experience any SAEs
Number of subjects participating in Phase 1 of study that discontinued study treatment due to a treatment emergent adverse event.
Number of subjects that experience any treatment-related adverse event.
Progression Free Survival in Phase 2 of the study for pancreatic and bladder cancer subjects.
| Arm | Type | Description |
|---|---|---|
| RX-3117 + Abraxane | EXPERIMENTAL | RX-3117: oral, 500 - 700 mg/ day for 5 days on/ 2 days off for 3 weeks. 1 washout week/ cycle. Abraxane: 75 - 125 mg/m\^2, infused once per week for 3 weeks. 1 washout week/ cycle. |
| RX-3117 | EXPERIMENTAL | All subjects will receive RX-3117. |
| Name | Type | Description |
|---|---|---|
| RX-3117 | DRUG | RX-3117 will be administered orally in combination with Abraxane. |
Inclusion Criteria: Disease Related 1. Subject has confirmed histologic or cytologic evidence of metastatic pancreatic cancer and has no prior treatment for metastatic pancreatic cancer. 2. Subject has measurable disease using Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1. 3. Subject...
Top 20 of 68 competitors
RX-3117 is an investigational small molecule being developed for the treatment of metastatic pancreatic cancer and solid tumors. It is currently in Phase 1 clinical development and has not been approved by the FDA. The drug is being studied in patients with advanced malignancies, including metastatic bladder cancer.
RX-3117 is a small molecule, but its specific molecular target has not been disclosed. The drug is being evaluated in Phase 1 clinical trials for its safety and efficacy in treating solid tumors and metastatic pancreatic cancer. Its mechanism of action is not publicly detailed in the available information.
RX-3117 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 to evaluate the drug's safety and efficacy in oncology indications.
RX-3117 is in Phase 1 clinical development. It is an investigational drug and has not received FDA approval. Two Phase 1 trials have been completed, including a dose-finding study in advanced malignancies and a combination study with Abraxane in metastatic pancreatic cancer.
RX-3117 has been studied in two completed Phase 1 trials. NCT02030067 was a dose-finding and safety study of oral single-agent RX-3117 in advanced malignancies, enrolling 127 patients. NCT03189914 evaluated RX-3117 in combination with Abraxane in metastatic pancreatic cancer, enrolling 46 patients.
RX-3117 is not known to have any alternative names. It is being developed as a single agent and in combination with Abraxane for the treatment of solid tumors and metastatic pancreatic cancer. No other names for this drug have been reported.