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NCT04830592: MOAT
A Study of NG-641 and Pembrolizumab in Squamous Cell Carcinoma of the Head and Neck
Phase 1 trial testing NG-641 in Squamous Cell Carcinoma of the Head and Neck in 36 participants. Completed in 4 October 2024.
7 December 2023
Quick facts
| Lead sponsor | Akamis Bio |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | sequential |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 36 |
| Start date | 4 November 2021 |
| Primary completion | 7 December 2023 |
| Estimated completion | 4 October 2024 |
| Sites | 4 locations across United Kingdom |
Drugs / interventions tested
- NG-641 — full drug profile →
- Pembrolizumab (pembrolizumab) — full drug profile →
Conditions studied
- Squamous Cell Carcinoma of the Head and Neck — all drugs for Squamous Cell Carcinoma of the Head and Neck →
Sponsor
Akamis Bio — full company profile →
Who can join
18 and older, any sex, with Squamous Cell Carcinoma of the Head and Neck. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
A multicentre, open-label, non-randomized, phase Ib neoadjuvant study of intravenous NG-641, as monotherapy or in combination with pembrolizumab, in patients with surgically resectable squamous cell carcinoma of the head and neck (SCCHN).
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Targeting cytokine and chemokine signaling pathways for cancer therapy.
Yi M, Li T, Niu M, Zhang H, et al · · 2024 · cited 264× · PMID 39034318 · DOI 10.1038/s41392-024-01868-3 -
Concepts in Oncolytic Adenovirus Therapy.
Mantwill K, Klein FG, Wang D, Hindupur SV, et al · · 2021 · cited 75× · PMID 34638863 · DOI 10.3390/ijms221910522 -
Safety and efficacy of the tumor-selective adenovirus enadenotucirev with or without paclitaxel in platinum-resistant ovarian cancer: a phase 1 clinical trial.
Moreno V, Barretina-Ginesta MP, García-Donas J, Jayson GC, et al · · 2021 · cited 42× · PMID 34893524 · DOI 10.1136/jitc-2021-003645 -
Cancer-associated fibroblasts: protagonists of the tumor microenvironment in gastric cancer.
Ozmen E, Demir TD, Ozcan G. · · 2024 · cited 30× · PMID 38562556 · DOI 10.3389/fmolb.2024.1340124 -
Current development in adenoviral vectors for cancer immunotherapy.
Biegert GWG, Rosewell Shaw A, Suzuki M. · · 2021 · cited 19× · PMID 34938857 · DOI 10.1016/j.omto.2021.11.014 -
Targeting Tumour-Associated Fibroblasts in Cancers.
Shah K, Mallik SB, Gupta P, Iyer A. · · 2022 · cited 18× · PMID 35814453 · DOI 10.3389/fonc.2022.908156 -
Clinical Advances and Future Directions of Oncolytic Virotherapy for Head and Neck Cancer.
Wang Z, Sun P, Li Z, Xiao S. · · 2023 · cited 13× · PMID 37958464 · DOI 10.3390/cancers15215291 -
A tumor-selective adenoviral vector platform induces transient antiphospholipid antibodies, without increased risk of thrombosis, in phase 1 clinical studies.
Khalil DN, Prieto González-Albo I, Rosen L, Lillie T, et al · · 2023 · cited 9× · PMID 36897458 · DOI 10.1007/s10637-023-01345-8
Verify or expand the search:
- PubMed search for NCT04830592
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of NG-641
Trials testing the same drug.
- NCT04053283 — First in Human Study With NG-641, a Tumour Selective Transgene Expressing Adenoviral Vector · Phase 1 · completed
Other recruiting trials for Squamous Cell Carcinoma of the Head and Neck
Currently open trials in the same condition.
- NCT07465276 — Neoadjuvant Ficerafusp Alfa With Pembrolizumab in Resectable SCC · Phase 2 · recruiting
- NCT06736379 — Intratumoral Delivery of Viral Replicon (saRNA) Particles Expressing IL-12 in Head and Neck Cancer · Phase 1 · recruiting
- NCT06223568 — Phase II Trial of Neoadjuvant Chemotherapy (NAC) Alone or in Combination With Immunotherapy Vaccine PRGN-2009 in Subject · Phase 2 · recruiting
- NCT05983133 — A Study of PF-08046052/SGN-EGFRd2 in Advanced Solid Tumors · Phase 1 · active not recruiting
- NCT05208762 — A Study of PF-08046054/SGN-PDL1V in Advanced Solid Tumors · Phase 1 · recruiting
Other Akamis Bio trials
Trials by the same sponsor.
- NCT06459869 — NG-350A Plus Chemoradiotherapy for Locally Advanced Rectal Cancer · Phase 1 · recruiting
- NCT05165433 — Study of NG-350A Plus Pembrolizumab in Metastatic or Advanced Epithelial Tumours (FORTIFY) · Phase 1 · completed
- NCT05043714 — Study of NG-641 in Combination With Nivolumab in Metastatic or Advanced Epithelial Tumours · Phase 1 · completed
- NCT04053283 — First in Human Study With NG-641, a Tumour Selective Transgene Expressing Adenoviral Vector · Phase 1 · completed
- NCT03852511 — First in Human Study of NG-350A (an Oncolytic Adenoviral Vector Which Expresses an Anti-CD40 Antibody) · Phase 1 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04830592 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 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 Akamis Bio
- Last refreshed: 24 March 2025
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/NCT04830592.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing