Safety and Efficacy of Oral Artesunate for Pre-cervical Cancer

NCT07095478 | Not Yet Recruiting Phase 2

• 2 other identifiers: 2023-MHL-002NMRR ID-24-01779-UWV
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 5

Brief Summary

NeoART-CIN is a Phase II clinical study evaluating the safety and effectiveness of oral artesunate in patients with pre-cancerous cervical intra-epithelial neoplasia (CIN2/3), to investigate if a course of treatment with oral artesunate can reverse pre-cancerous changes in the cervix and prevent the development and progression of invasive cancer. Findings from this study will increase our understanding of the effects of artesunate on CIN2/3 and if confirmatory inform future clinical studies.

Conditions

CIN 2/3

Keywords

CIN; HPV; drug repurposing; Artesunate; antimalarial

Outcome Measures

Primary Outcomes (1)

• Histological regression of CIN2/3 on colposcopy and biopsy at Day 90

  Histological regression will be defined as histologic regression to CIN1 or less.

  From enrolment to end of trial at Day 90

Secondary Outcomes (12)

• HPV DNA viral clearance at Day 90.

  Measured at the end of the trial at Day 90

• Change in Vaginome Composition

  At Day 1 , Day 64 of enrolment and at the end of the trial at Day 90

• Change in Gut Microbiome Composition Assessed

  At Day 1 , Day 64 of enrolment and at the end of the trial at Day 90

• Adverse events affecting patients as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v5.0

  Assessment at Day 90 following study intervention

• Patient-Reported Quality of Life (QoL) Assessed by Validated Questionnaires at Baseline

  Assessment at Day 1 of study intervention (baseline)

Study Arms (1)

Artesunate

EXPERIMENTAL

200mg oral tablets once daily for 14 days, with 7 days break for 3 cycles.

Drug: Artesunate

Interventions

Artesunate DRUG

Patients with HPV positive CIN2/3 will receive 3 cycles of oral artesunate 200mg OD prior to standard of care therapeutic LLETZ. Each 21 day treatment cycle will comprise oral artesunate 200mg OD for 14 days followed by a 7 day treatment break.

Artesunate

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 or over
• Histologically proven HPV positive cervical CIN2/3
• WHO performance status 0-2
• Adequate full blood count:
• White Cell Count (WCC) \>3.0 x 109 /l;
• Platelets \>100 x 109/l;
• Haemoglobin (Hb) \>80g/L
• Adequate renal function:
• Glomerular Filtration Rate \>30ml/min
• Adequate hepatobiliary function:
• Total bilirubin \< 3 x Upper limit normal
• Female participants of child bearing potential must have a negative pregnancy test \< 72 hours prior to initiating study intervention and agree to avoid pregnancy using adequate, medically approved contraceptive precautions for up to 6 weeks after the last dose of study treatment intervention
• Patient able and willing to provide written, informed consent for the study

You may not qualify if:

• Contraindication to the use of artesunate due to hypersensitivity
• Pregnancy or lactation
• Weight \< 52 kg
• History of previous CIN
• Immunocompromised patients

Sponsors & Collaborators

• Metanoic Health Ltd.: lead
• Clinical Research Malaysia: collaborator

Study Sites (5)

Pusat Perubatan Universiti Malaya

Kuala Lumpur, Kuala Lumpur, 59100, Malaysia

Location

Institut Kanser Negara

Putrajaya, Kuala Lumpur, 62250, Malaysia

Location

Hospital Umum Sarawak

Kuching, Sarawak, 93586, Malaysia

Location

Hospital Ampang

Ampang, Selangor, 68000, Malaysia

Location

Hospital Selayang

Batu Caves, Selangor, 68100, Malaysia

Location

Related Publications (10)

• Liu Z, Zhang J, Li S, Jiang J. Artesunate Inhibits Renal Ischemia Reperfusion-Stimulated Lung Inflammation in Rats by Activating HO-1 Pathway. Inflammation. 2018 Feb;41(1):114-121. doi: 10.1007/s10753-017-0669-3.

  PMID: 28921399 BACKGROUND

• Krishna S, Bustamante L, Haynes RK, Staines HM. Artemisinins: their growing importance in medicine. Trends Pharmacol Sci. 2008 Oct;29(10):520-7. doi: 10.1016/j.tips.2008.07.004. Epub 2008 Aug 25.

  PMID: 18752857 BACKGROUND

• Kay J, Thadhani E, Samson L, Engelward B. Inflammation-induced DNA damage, mutations and cancer. DNA Repair (Amst). 2019 Nov;83:102673. doi: 10.1016/j.dnarep.2019.102673. Epub 2019 Jul 25.

  PMID: 31387777 BACKGROUND

• Jansen FH, Adoubi I, J C KC, DE Cnodder T, Jansen N, Tschulakow A, Efferth T. First study of oral Artenimol-R in advanced cervical cancer: clinical benefit, tolerability and tumor markers. Anticancer Res. 2011 Dec;31(12):4417-22.

  PMID: 22199309 BACKGROUND

• Ho WE, Peh HY, Chan TK, Wong WS. Artemisinins: pharmacological actions beyond anti-malarial. Pharmacol Ther. 2014 Apr;142(1):126-39. doi: 10.1016/j.pharmthera.2013.12.001. Epub 2013 Dec 6.

  PMID: 24316259 BACKGROUND

• Heinonen A, Gissler M, Riska A, Paavonen J, Tapper AM, Jakobsson M. Loop electrosurgical excision procedure and the risk for preterm delivery. Obstet Gynecol. 2013 May;121(5):1063-1068. doi: 10.1097/AOG.0b013e31828caa31.

  PMID: 23635744 BACKGROUND

• Hanahan D, Weinberg RA. Hallmarks of cancer: the next generation. Cell. 2011 Mar 4;144(5):646-74. doi: 10.1016/j.cell.2011.02.013.

  PMID: 21376230 BACKGROUND

• Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12.

  PMID: 30207593 BACKGROUND

• Deeken JF, Wang H, Hartley M, Cheema AK, Smaglo B, Hwang JJ, He AR, Weiner LM, Marshall JL, Giaccone G, Liu S, Luecht J, Spiegel JY, Pishvaian MJ. A phase I study of intravenous artesunate in patients with advanced solid tumor malignancies. Cancer Chemother Pharmacol. 2018 Mar;81(3):587-596. doi: 10.1007/s00280-018-3533-8. Epub 2018 Feb 1.

  PMID: 29392450 BACKGROUND

• Augustin Y, Staines HM, Krishna S. Artemisinins as a novel anti-cancer therapy: Targeting a global cancer pandemic through drug repurposing. Pharmacol Ther. 2020 Dec;216:107706. doi: 10.1016/j.pharmthera.2020.107706. Epub 2020 Oct 16.

  PMID: 33075360 BACKGROUND

MeSH Terms

Interventions

Artesunate

Intervention Hierarchy (Ancestors)

Artemisinins; Reactive Oxygen Species; Free Radicals; Inorganic Chemicals; Organic Chemicals; Sesquiterpenes; Terpenes; Hydrocarbons

Study Officials

• Professor Sanjeev Krishna, FRCP, ScD

  Centre of Diagnostics and Therapeutics

  STUDY CHAIR

• Dr Yolanda Augustin

  Centre of Diagnostics and Therapeutics

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Professor Sanjeev Krishna, FRCP,ScD

CONTACT

+442087250446; skrishna@cadt.org.uk

Dr Yolanda Augustin

CONTACT

yaugustin@cadt.org.uk

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2025
• First Posted: July 31, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2028
• Last Updated: July 31, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR

Locations

MY (5)