Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
SRF617 · 1 trial · 1 indication
Evaluation of dose-limiting toxicity (DLT).
| Arm | Type | Description |
|---|---|---|
| Monotherapy Dose Escalation | EXPERIMENTAL | The monotherapy dose escalation portion of the study will evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary efficacy of SRF617 as monotherapy in up to 36 patients with advanced solid tumors. |
| Monotherapy Tumor Biopsy Expansion | EXPERIMENTAL | The monotherapy tumor biopsy expansion portion of the study will further evaluate the safety and intratumoral pharmacodynamics of SRF617 monotherapy in up to 20 patients at cleared and recommended phase 2 dose levels. |
| Combination Therapy - SRF617 with Gemcitabine + Albumin-bound Paclitaxel Dose Escalation | EXPERIMENTAL | This portion of the study will evaluate the safety, tolerability, PK, and preliminary efficacy of SRF617 in combination with gemcitabine + albumin-bound paclitaxel in patients with locally advanced or metastatic solid tumors. |
| Combination Therapy - SRF617 with Pembrolizumab Dose Escalation | EXPERIMENTAL | This portion of the study will evaluate the safety, tolerability, PK, and preliminary efficacy of SRF617 in combination with pembrolizumab (Keytruda®) in patients with locally advanced or metastatic solid tumors. |
| Combination Therapy - SRF617 with Gemcitabine + Albumin-bound Paclitaxel Dose Expansion | EXPERIMENTAL | Enrollment at the recommended phase 2 combination dose may be expanded to include approximately 10 additional patients with advanced pancreatic ductal adenocarcinoma (PDAC) to further evaluate safety with SRF617 and gemcitabine + albumin-bound paclitaxel combination therapy. |
| Combination Therapy - SRF617 with Pembrolizumab Dose Expansion GC/GEJ | EXPERIMENTAL | Enrollment at the recommended phase 2 combination dose may be expanded to include approximately 28 additional patients with 2 anti-PD-(L) 1 naive HER2 negative gastric cancer (GC) or gastroesophageal junction (GEJ) adenocarcinoma to further evaluate safety with SRF617 and pembrolizumab combination therapy. |
| SRF617 + Pembrolizumab + Gemcitabine + Albumin-bound Paclitaxel Quadruplet Dose Expansion | EXPERIMENTAL | Enrollment at the recommended phase 2 combination dose established in the combination dose escalation arms (if recommended phase 2 combination doses differ, the lower of the starting 2 doses will be used) may be expanded to include up to approximately 30 additional patients with advanced 1L PDAC. |
| Combination Therapy - SRF617 with Pembrolizumab Dose Expansion anti-PD-L1 GC/GEJ, PD-L1+ NSCLC | EXPERIMENTAL | Enrollment at the recommended phase 2 combination dose may be expanded to include approximately 29 additional patients with anti-PD-(L) 1 relapsed/refractory PD-L1+ HER2 negative gastric cancer (GC) or gastroesophageal junction (GEJ) adenocarcinoma or advanced PD-L1+ NSCLC to further evaluate safety with SRF617 and pembrolizumab combination therapy. |
| Name | Type | Description |
|---|---|---|
| SRF617 | DRUG | SRF617 prevents CD39 mediated conversion of adenosine triphosphate (ATP) and adenosine diphosphate (ADP) to adenosine monophosphate (AMP) and phosphate, leading to an increase in extracellular ATP and a reduction in adenosine levels within the tumor microenvironment (TME). There is an important role for extracellular ATP and adenosine in cancer maintenance and progression, and maintaining high levels of ATP (and low levels of adenosine) in the TME may have anticancer therapeutic activity. |
| Gemcitabine | DRUG | Gemcitabine as an intravenous (IV) infusion |
| Albumin-Bound Paclitaxel | DRUG | Albumin-bound paclitaxel as an IV infusion |
| Pembrolizumab | DRUG | Pembrolizumab as an IV infusion . |
Abbreviated Inclusion Criteria: 1. Be ≥ 18 years of age on day of signing the informed consent 2. Experienced disease progression during or after standard therapy or were intolerant of standard therapy, and for whom no appropriate therapies are available (based on the judgment of the Investigator)....
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 2 | PHASE2 | pembrolizumab |
| Incyte Corporation | INCY | 1 | PHASE2 | Chemotherapy, Retifanlimab |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | E7 TCR-T cells, Aldesleukin |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115, pembrolizumab |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
SRF617 is an investigational small molecule being studied for the treatment of advanced solid tumors. It is currently in Phase 1 clinical development. The drug has been evaluated in a completed clinical trial involving patients with advanced solid tumors.
SRF617 is being developed by Coherus Oncology, Inc., a subsidiary of Coherus BioSciences (NASDAQ: CHRS). The company is conducting clinical research on this investigational oncology drug for advanced solid tumors.
SRF617 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. A Phase 1 clinical trial of SRF617 in patients with advanced solid tumors has been completed.
SRF617 has been studied in one clinical trial, identified as NCT04336098, titled 'Study of SRF617 in Patients With Advanced Solid Tumors.' This Phase 1 trial was completed and enrolled 85 participants in the United States and Canada.
SRF617 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The completed clinical trial for SRF617 was a Phase 1 study, and the drug has not yet received approval for any indication.