Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
SRA737 · 1 trial · 1 indication
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 | - |
| 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. |
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...
SRA737 is an investigational small molecule being studied for the treatment of advanced solid tumors and advanced solid tumors or non-Hodgkin's lymphoma (NHL). It is in Phase 1 clinical development and is not yet approved by regulatory authorities.
SRA737 is being developed by GSK plc, a pharmaceutical company listed on the stock exchange under the ticker GSK. The drug is currently in Phase 1 clinical trials for advanced cancer indications.
SRA737 is in Phase 1 clinical development. It has completed two Phase 1 trials, and it remains an investigational drug, meaning it has not received regulatory approval and is still being evaluated for safety and efficacy.
SRA737 has been studied in two completed Phase 1 trials. The first, NCT02797964, evaluated SRA737 alone in subjects with advanced solid tumors or non-Hodgkin's lymphoma. The second, NCT02797977, tested SRA737 in combination with gemcitabine and cisplatin or gemcitabine alone in advanced cancer subjects.
SRA737 is a small molecule designed to target specific pathways involved in cancer cell growth. As an investigational oncology drug, it is being studied for its potential to treat advanced solid tumors and non-Hodgkin's lymphoma by interfering with cancer cell mechanisms.