Clinical Trials

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)

Check the CCT245737 (SRA737) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

CCT245737 selectively binds to Checkpoint kinase 1 (CHK1) to inhibit its kinase activity, thereby blocking CHK1-mediated phosphorylation of cell cycle regulatory proteins and disrupting DNA damage checkpoint signaling. This disruption leads to impaired DNA repair, premature mitotic entry, and apoptosis, ultimately inhibiting tumor cell proliferation in advanced solid tumors and Non-Hodgkin's lymphoma.

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>).

Note: Technical data last updated: Sep 1, 2026.