Clinical Trials

A Phase 1 clinical trial sponsored by Chugai Pharmaceutical investigated the therapeutic potential of LUNA18 as monotherapy and in combination regimens for patients with locally advanced or metastatic solid tumors. Designed as an open-label, dose-escalation, and cohort expansion study, the investigation evaluated the drug's application in clinical oncology. Database records indicate that recruitment for this Phase 1 trial has been terminated.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT05012618 TERMINATED
Locally Advanced or Metastatic Solid Tumors
Chugai Pharmaceutical
 2021-10-08 PHASE1

(data from https://clinicaltrials.gov, updated on 2025-12-24)

Check the LUNA18 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

LUNA18 is a cyclic peptide inhibitor that selectively binds to the KRAS G12D mutant protein, blocking its key interaction with the guanine nucleotide exchange factor SOS1 and preventing downstream oncogenic signal transduction to halt cellular proliferation. By inhibiting KRAS-driven pathway activity, LUNA18 exerts potent antiproliferative effects in KRAS-mutant cancer cells, underscoring its therapeutic rationale for addressing locally advanced or metastatic solid tumors.

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.