INX-315 Clinical Trials

Size	Price	Qty
5mg	USD 197
25mg	USD 497

Clinical Trials

Incyclix Bio is currently sponsoring a clinical trial to evaluate INX-315 in patients with advanced or metastatic solid tumors, specifically targeting hormone receptor-positive/HER2-negative breast cancer, ovarian cancer, and CCNE1-amplified tumors. This actively recruiting, open-label Phase I/Phase II study aims to assess the safety, tolerability, pharmacokinetics, and therapeutic efficacy of INX-315 in these patient cohorts.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05735080	RECRUITING	Breast Cancer; Breast Cancer Metastatic; Hormone Receptor Positive Tumor; Human Epidermal Growth Factor 2 Negative Carcinoma of Breast; Ovarian Cancer; CCNE1 Amplification; Solid Tumor; Advanced Cancer; Metastatic Cancer	Incyclix Bio	2023-03-28	PHASE1; PHASE2

(data from https://clinicaltrials.gov, updated on 2026-04-01)

Check the INX-315 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

INX-315 functions as an orally active, selective inhibitor of cyclin-dependent kinase 2 (CDK2) that blocks downstream CDK2 substrate phosphorylation and induces cell cycle arrest in the G1 phase. By inhibiting cell proliferation and suppressing tumor growth, this targeted kinase inhibition provides the mechanistic rationale for treating CCNE1-amplified solid tumors, metastatic ovarian cancer, and hormone receptor-positive/HER2-negative 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>).