Clinical Trials

A Phase 1 open-label clinical trial sponsored by Erasca, Inc. is actively recruiting participants with advanced metastatic solid tumors driven by oncogenic RAS signaling to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and early therapeutic efficacy of ERAS-0015. By establishing the compound's safety profile and optimal dosing parameters, the study seeks to clarify its therapeutic potential in treating complex solid tumor malignancies.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06983743 RECRUITING
Metastatic Solid Tumors
Erasca, Inc.
 2025-06-05 PHASE1

(data from https://clinicaltrials.gov, updated on 2026-09-01)

Check the ERAS-0015 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

ERAS-0015 operates as a tricomplex inhibitor that binds to Cyclophilin A to form a high-affinity complex with active GTP-bound RAS, effectively preventing RAS from interacting with downstream effector proteins. This steric blockade interrupts downstream oncogenic signaling cascades to induce apoptosis and inhibit cellular proliferation, demonstrating direct therapeutic relevance for suppressing tumor growth in 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.