G1T38 Clinical Trials

Size	Price	Qty
2mg	USD 147
5mg	USD 247

Clinical Trials

Multiple clinical trials sponsored by G1 Therapeutics Inc. evaluate G1T38 (lerociclib) across Phase 1 and Phase 1/2 studies in healthy volunteers and patients with solid tumors. These include completed investigations assessing safety, pharmacokinetics, and food effect in healthy subjects, as well as combination regimens in EGFR mutation-positive metastatic non-small-cell lung cancer. Additionally, an active, non-recruiting trial evaluates the drug in patients with hormone receptor-positive breast cancer to characterize its safety and preliminary antitumor activity.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT03455829	Completed	Carcinoma Non-Small-Cell Lung\|Lung Cancer\|Non-small Cell Lung Cancer	G1 Therapeutics Inc.	2018-03-29	Phase 1\|Phase 2
NCT02983071	Active not recruiting	Carcinoma Ductal Breast\|Breast Cancer\|Breast Neoplasm	G1 Therapeutics Inc.	2017-01	Phase 1\|Phase 2
NCT02821624	Completed	Healthy Volunteers	G1 Therapeutics Inc.	2016-05	Phase 1

(data from https://clinicaltrials.gov, updated on 2024-05-22)

Check the G1T38 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

G1T38 (Lerociclib) selectively binds to cyclin-dependent kinases 4 and 6 (CDK4/6), inhibiting the phosphorylation of retinoblastoma protein and preventing transition from the G1 to the S phase of the cell cycle to induce G1 arrest. By suppressing CDK4/6-dependent cell proliferation, lerociclib halts tumor cell growth, demonstrating therapeutic relevance in clinical trial indications such as non-small-cell lung cancer and hormone receptor-positive breast cancer.

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>).