Multiple clinical trials sponsored by Sierra Oncology LLC (a GSK company) have evaluated CCT245737 (SRA737), an oral Checkpoint kinase 1 inhibitor, across Phase I and Phase II evaluations. These completed studies investigated the safety and efficacy of the drug both as monotherapy and in combination regimens with standard chemotherapeutics like gemcitabine and cisplatin for advanced solid tumors and Non-Hodgkin's lymphoma. Overall, these clinical investigations establish the early-stage profile of CCT245737 in patients with refractory malignancies.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT02797977 | COMPLETED | Advanced Solid Tumors |
Sierra Oncology LLC - a GSK company |
2016-07 | PHASE1; PHASE2 |
| NCT02797964 | COMPLETED | Advanced Solid Tumors or Non-Hodgkin's Lymphoma (NHL) |
Sierra Oncology LLC - a GSK company |
2016-07 | PHASE1; PHASE2 |
| NCT02797964 | Completed | Advanced Solid Tumors or Non-Hodgkin''s Lymphoma (NHL) |
Sierra Oncology LLC - a GSK company |
2016-07 | Phase 1|Phase 2 |
| NCT02797977 | Completed | Advanced Solid Tumors |
Sierra Oncology LLC - a GSK company |
2016-07 | Phase 1|Phase 2 |
(data from https://clinicaltrials.gov, updated on 2023-06-22)
Mechanism and Biochemical Profile
Appendix RUO and cGMP Quality Standards
| Quality Dimension | RUO (Research Use Only) | cGMP (Current Good Manufacturing Practice) |
|---|---|---|
| Clinical Applicability | Prohibited in human clinical trials or medical diagnostics. | Mandatory for human clinical trials (Phase I–III) and therapies. |
| Regulatory Status | Non-regulated grade; exempt from drug manufacturing laws. | Legally enforced by health authorities (e.g., FDA, EMA, NMPA). |
| Facility Environment | Unclassified analytical or research laboratories. | Validated Cleanrooms (ISO Class 5–8) with continuous monitoring. |
| Quality Control | Basic purity and activity testing. | Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma). |
| Process Validation | Basic equipment calibration; no process validation required. | Full qualification (IQ/OQ/PQ) and complete batch records. |
| Quality Assurance | Vendor self-declared without required formal QMS. | Mandatory QA/QC unit, Change Control, CAPA, and vendor audits. |
| Regulatory Impact | High risk of IND rejection if used as a critical raw material. | Required for IND/NDA filings, supported by Drug Master Files (DMF). |
Footnotes
Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).