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NCT05227651
AK104 in Neoadjuvant Treatment of Cervical Cancer
Completed
Phase 2
Last updated 1 November 2024
What this trial tests
Phase 2 trial testing AK104 in Cervical Cancer in 14 participants. Completed in 27 September 2024.
Timeline
10 February 2023
Primary endpoint
27 September 2024
27 September 2024
27 September 2024
Quick facts
| Lead sponsor | Akeso |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 14 |
| Start date | 10 February 2023 |
| Primary completion | 27 September 2024 |
| Estimated completion | 27 September 2024 |
| Sites | 1 location across China |
Drugs / interventions tested
- AK104 — full drug profile →
Conditions studied
- Cervical Cancer — all drugs for Cervical Cancer →
Sponsor
Akeso — full company profile →
Who can join
Adults 18 to 75, female only, with Cervical Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Phase II open label study to evaluate the safety and efficacy of AK104 (anti-PD-1 and CTLA-4 bispecific antibody) in neoadjuvant treatment of cervical cancer.
Publications & conference data
5 peer-reviewed publications reference this trial (live from Europe PMC):
-
Bispecific antibodies in cancer therapy: Target selection and regulatory requirements.
Sun Y, Yu X, Wang X, Yuan K, et al · · 2023 · cited 62× · PMID 37719370 · DOI 10.1016/j.apsb.2023.05.023 -
Bispecific antibodies targeting immunomodulatory checkpoints for cancer therapy.
Zhang T, Lin Y, Gao Q. · · 2023 · cited 47× · PMID 36971124 · DOI 10.20892/j.issn.2095-3941.2023.0002 -
Bispecific Antibodies in Cancer Immunotherapy: A Novel Response to an Old Question.
Ordóñez-Reyes C, Garcia-Robledo JE, Chamorro DF, Mosquera A, et al · · 2022 · cited 22× · PMID 35745815 · DOI 10.3390/pharmaceutics14061243 -
Immunotherapy in cervical cancer: From the view of scientometric analysis and clinical trials.
Xing Y, Yasinjan F, Du Y, Geng H, et al · · 2023 · cited 9× · PMID 36817443 · DOI 10.3389/fimmu.2023.1094437 -
Comprehensive overview of antibody drug-related clinical studies in gynecology: insights from ClinicalTrials.gov.
Zhou X, Xiao L, Lai F, Chen W, et al · · 2025 · cited 1× · PMID 40417700 · DOI 10.3389/fmed.2025.1521587
Verify or expand the search:
- PubMed search for NCT05227651
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of AK104
Trials testing the same drug.
- NCT07052253 — A Phase II Clinical Study of AK104/AK112 in Combination With TT-00420 Tablet for Advanced HCC. · Phase 2 · recruiting
- NCT06946836 — Comparison of Neoadjuvant Cadonilimab Versus Chemotherapy Combined With PD-1 in the Treatment of Resectable Non-Small Ce · Phase 2 · not yet recruiting
- NCT06560112 — An Exploratory, Multi-cohort Phase II Study of Combination Therapy With AK104 and AK112 for Recurrent Ovarian Cancer · Phase 2 · recruiting
- NCT06542549 — Efficacy and Safety of AK104 (PD-1/CTLA-4 Bispecial Antibody) Combined With Chemotherapy for Neoadjuvant Treatment of Ad · Phase 3 · not yet recruiting
- NCT06371157 — A Study of AK104+Lenvatinib in Combination With Transarterial Chemoembolization (TACE) Versus TACE in Participants With · Phase 3 · recruiting
Other recruiting trials for Cervical Cancer
Currently open trials in the same condition.
- NCT07276360 — Hypofractionated Radiotherapy for the Treatment of Locally Advanced Cervical Cancer in Uganda · Phase 2 · recruiting
- NCT05570422 — A Study to Evaluate the Safety, Tolerability, Preliminary Efficacy of KRC-01 · Phase 1 · recruiting
- NCT07225530 — Implementation of Screen, Treat, and Triage for Women Living With HIV in La Romana (iSTAR) · NA · recruiting
- NCT07209917 — Secondary Cervical Cancer Prevention of Vulnerable Women With HPV and HIV Co-infection in India · NA · recruiting
- NCT07256236 — SKB264 Plus QL1706 in Recurrent or Metastatic Cervical Cancer · Phase 2 · recruiting
Other Akeso trials
Trials by the same sponsor.
- NCT07449780 — A Study of AK104 (SC) in Combination With Oxaliplatin and Capecitabine (XELOX) Versus AK104 (IV) in Combination With XEL · Phase 3 · not yet recruiting
- NCT07412613 — Neoadjuvant/Adjuvant AK104 in Microsatellite Instability-high or Mismatch Repair-deficient, Resectable Colon Cancer · Phase 3 · not yet recruiting
- NCT07357220 — A Study of AK112 in Combination With VG2025 in Colorectal Cancer With Liver Metastases · Phase 1, PHASE2 · not yet recruiting
- NCT07436234 — A Study to Evaluate the Efficacy and Safety of AK139 in Participants With Seasonal Allergic Rhinitis · Phase 2 · not yet recruiting
- NCT07436221 — A Study to Evaluate the Efficacy and Safety of AK139 in Participants With Asthma · Phase 2 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
Data sources for this page
- Trial protocol + status: ClinicalTrials.gov NCT05227651 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Akeso
- Last refreshed: 1 November 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05227651.
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