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 | 3 | PHASE2 | Pembrolizumab, Gardasil 9 |
| Incyte Corporation | INCY | 1 | PHASE2 | Retifanlimab |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115 |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | Aldesleukin |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
SRF617 is an investigational small molecule being studied in adults with advanced solid tumors. It was evaluated in a Phase 1 clinical trial that enrolled 85 patients in the United States and Canada. It is not an approved therapy and remains in clinical development for oncology indications.
SRF617 is being developed by Coherus Oncology, Inc., which trades on the Nasdaq under the ticker CHRS. The company sponsored the Phase 1 study of SRF617 in patients with advanced solid tumors.
SRF617 is in Phase 1 development. Its single clinical trial, NCT04336098, was a Phase 1 study in advanced solid tumors that has been completed, with 85 patients enrolled. No later-phase trials of SRF617 have been initiated.
SRF617 has been studied in one clinical trial, NCT04336098, titled Study of SRF617 in Patients With Advanced Solid Tumors. The Phase 1 trial enrolled 85 participants aged 18 years and older across the United States and Canada and is now completed.
No. SRF617 is an investigational small molecule and has not been approved by the FDA. It has completed a single Phase 1 trial in advanced solid tumors and remains in clinical development.
The Phase 1 trial of SRF617, NCT04336098, was a controlled study but was not randomized and not double blinded. It enrolled 85 patients with advanced solid tumors and used biomarker-based selection for study eligibility.