Clinical Trials

Multiple clinical trials across Phase I and Phase II evaluate lunresertib (RP-6306) as monotherapy and in combination regimens with chemotherapeutic agents or second-site targeted inhibitors. These studies investigate the compound primarily for advanced solid tumors, recurrent TP53-mutated ovarian and uterine cancers, and ER+/HER2- metastatic breast cancer. Sponsored by pharmaceutical companies such as Repare Therapeutics and Debiopharm alongside academic institutions including the University Health Network and the Canadian Cancer Trials Group, trial recruitment statuses range from actively recruiting and active not recruiting to terminated.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT05601440 RECRUITING
Breast Cancer
Canadian Cancer Trials Group
 2023-06-13 PHASE2
NCT05605509 COMPLETED
Advanced Cancer
Canadian Cancer Trials Group
 2023-05-24 PHASE2
NCT06107868 ACTIVE_NOT_RECRUITING
Recurrent Ovarian Cancer; Recurrent Uterine Cancer; Metastatic Cancer; Advanced Cancer
University Health Network, Toronto
 2024-03-20 PHASE1
NCT05147350 TERMINATED
Advanced Solid Tumor
Debiopharm International SA
 2022-08-09 PHASE1
NCT05147272 TERMINATED
Adult Solid Tumor
Debiopharm International SA
 2021-12-16 PHASE1
NCT06107868 Active not recruiting
Recurrent Ovarian Cancer|Recurrent Uterine Cancer|Metastatic Cancer|Advanced Cancer
University Health Network Toronto
 2024-03-20 Phase 1
NCT05147350 Active not recruiting
Advanced Solid Tumor
Repare Therapeutics
 2022-08-09 Phase 1
NCT05147272 Active not recruiting
Adult Solid Tumor
Repare Therapeutics
 2021-12-16 Phase 1
NCT04855656 Recruiting
Advanced Solid Tumor
Repare Therapeutics|Debiopharm International SA
 2021-04-30 Phase 1

(data from https://clinicaltrials.gov, updated on 2026-05-07)

Check the RP-6306 (lunresertib) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Lunresertib (RP-6306) selectively binds to and inhibits protein kinase, membrane associated tyrosine/threonine 1 (PKMYT1), preventing the inhibitory phosphorylation of CDK1 and forcing tumor cells into premature mitosis. This targeted disruption leads to severe mitotic catastrophe and unscheduled cell death, offering therapeutic relevance for clinical trials treating advanced solid tumors, recurrent ovarian and uterine cancers, and metastatic 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>).

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