Clinical Trials

Multiple clinical trials sponsored by Redx Pharma have evaluated the small-molecule inhibitor zamaporvint (RXC004) for colorectal cancer and advanced solid malignancies across Phase 1 and Phase 2 studies. Phase 1 trials have assessed the agent's safety, tolerability, and combination regimens, with recruitment recorded as completed or active, not recruiting. Additionally, Phase 2 studies have evaluated its preliminary efficacy both as a monotherapy and in combination with nivolumab.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT04907539 COMPLETED
Colorectal Cancer
Redx Pharma Ltd
 2021-11-08 PHASE2
NCT04907851 COMPLETED
Advanced Solid Tumours
Redx Pharma Ltd
 2021-12-10 PHASE2
NCT03447470 COMPLETED
Cancer; Solid Tumor
Redx Pharma Ltd
 2019-03-18 PHASE1
NCT04907539 Completed
Colorectal Cancer
Redx Pharma Plc
 2021-11-08 Phase 2
NCT03447470 Active not recruiting
Cancer|Solid Tumor
Redx Pharma Plc
 2019-03-18 Phase 1

(data from https://clinicaltrials.gov, updated on 2025-04-16)

Check the Zamaporvint (RXC004) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Zamaporvint (RXC004) selectively binds to and inhibits membrane-bound O-acyltransferase Porcupine, thereby preventing the palmitoylation and subsequent secretion of Wnt ligands required for downstream pathway activation. This blockade suppresses proliferation in Wnt ligand-dependent tumor cell lines, providing a therapeutic rationale for inhibiting tumor growth in clinical conditions such as colorectal cancer and advanced 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.