Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as SRA737
SRA737, gemcitabine, cisplatin · 2 trials · 2 indications
Treatment-emergent adverse events (TEAEs) were reported until the safety Follow up (SFU) visit, 30 days after the last dose of SRA737 or prior to the initiation of a new anticancer treatment, whichever came first.
The highest dose at which ≤ 33% of subjects have a dose limiting toxicity (DLT) in a cohort of up to 6 subjects.
The RP2D and schedule were defined by the Cohort Review Committee at the end of the study and took all clinically relevant toxicity, PK and PDn data into account. The RP2D was to be a dose equal to or less than the MTD for the selected schedule.
The disease control rate (DCR) was defined as the number of subjects achieving complete response (CR) + partial response (PR) + stable disease (SD) per RECIST 1.1 criteria. Since no subjects achieved CR or PR in this study, the DCR represents the proportion of subjects in each group who achieved SD.
Time to progression (TTP) was defined as the time from Cycle 1 Day 1 to the earliest date of radiographic disease progression per RECIST 1.1, or if the subject did not experience disease progression, to the last imaging assessment. TTP was analyzed using the K-M method.
Progression free survival (PFS) was defined as time from Cycle 1 Day 1 to the earliest date of radiographic disease progression per RECIST 1.1 or death, whichever happened first. Censoring rules are defined in the SAP. PFS was analyzed using the K-M method.
Overall survival (OS) was defined as time from Cycle 1 Day 1 to the date of death (or date last known to be alive). OS was analyzed using the K-M method.
| Arm | Type | Description |
|---|---|---|
| Open label | EXPERIMENTAL | - |
| Standard-Dose Triplet Combination | EXPERIMENTAL | SRA737 will be administered orally on Days 2, 3, 9, and 10 of each 21-day cycle. Subjects will receive a single dose of SRA737 between 4 to 7 days prior to starting the first cycle for PK profiling. Gemcitabine will be administered intravenously on Days 1 and 8 of each 21-day cycle. Cisplatin will be administered on Day 1 of each 21-day cycle. Subjects can continue taking the study treatment if they are safely receiving clinical benefit and able to follow the requirements of the study. |
| Low-Dose Gemcitabine Combination | EXPERIMENTAL | SRA737 will be administered orally on Days 2, 3, 9, 10, 16, and 17 of each 28-day cycle. Subjects will receive a single dose of SRA737 between 4 to 7 days prior to starting the first cycle. Gemcitabine will be administered intravenously on Days 1, 8, and 15 of each 28-day cycle. Subjects can continue taking the study treatment if they are safely receiving clinical benefit and able to follow the requirements of the study. |
| Name | Type | Description |
|---|---|---|
| SRA737 | DRUG | SRA737 will be administered orally on each day of a 28-day cycle. Subjects will receive a single dose of SRA737 between 4 to 7 days prior to starting the first cycle for PK profiling. Subjects can continue taking SRA737 if they are receiving clinical benefit and able to safely take the drug and follow the requirements of the study. |
| SRA737, gemcitabine, cisplatin | DRUG | - |
| SRA737, gemcitabine | DRUG | - |
Key Inclusion Criteria: 1. For Dose Escalation Only: any locally advanced or metastatic, histologically or cytologically proven solid tumor or NHL, relapsed after or progressing despite conventional treatment 2. Life expectancy of at least 12 weeks 3. World Health Organization (WHO) performance sta...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 2 | PHASE2 | Pembrolizumab, Gardasil 9 |
| Incyte Corporation | INCY | 1 | PHASE2 | Retifanlimab |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | Aldesleukin |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115 |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
SRA737 is an investigational small molecule being studied in oncology for the treatment of advanced solid tumors and non-Hodgkin's lymphoma. It has been evaluated in Phase 1 clinical development, both as a single agent and in combination with gemcitabine and cisplatin, in adult patients with advanced cancer.
SRA737 is being developed by GSK plc, which trades under the ticker GSK. The company has sponsored Phase 1 clinical trials of the compound in advanced solid tumors and non-Hodgkin's lymphoma, including studies conducted in Spain and the United Kingdom.
SRA737 is in Phase 1 clinical development. It is an investigational agent and has not been approved for any indication. Two Phase 1/2 trials have been completed, one evaluating SRA737 with gemcitabine and cisplatin or gemcitabine alone, and another evaluating SRA737 in advanced cancer.
SRA737 has been studied in two completed Phase 1/2 trials. NCT02797977 evaluated SRA737 in combination with gemcitabine and cisplatin or gemcitabine alone in advanced solid tumors, enrolling 153 patients in Spain and the United Kingdom. NCT02797964 evaluated SRA737 in advanced solid tumors or non-Hodgkin's lymphoma, enrolling 107 patients in the United Kingdom.
No. SRA737 is a distinct investigational small molecule developed by GSK. Gemcitabine and cisplatin are separate chemotherapy agents that were administered in combination with SRA737 in the Phase 1/2 trial NCT02797977, which studied the combination regimen in patients with advanced solid tumors.