NCT04659369 is a Phase 1 clinical trial of CMAB819 in Squamous Cell Carcinoma of the Head and Neck, sponsored by Taizhou Mabtech Pharmaceutical Co.,Ltd.

Who is sponsoring NCT04659369?

NCT04659369 is sponsored by Taizhou Mabtech Pharmaceutical Co.,Ltd.

What drugs are being tested in NCT04659369?

Interventions in NCT04659369: CMAB819, Nivolumab.

What condition does NCT04659369 study?

NCT04659369 studies Squamous Cell Carcinoma of the Head and Neck.

Is NCT04659369 still recruiting?

NCT04659369 is currently terminated. Last updated 9 April 2024.

Last reviewed 2024-04-09 · How we verify

NCT04659369

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Study of Pharmacokinetic, Safety, Immunogenicity and Efficacy of CMAB819 and Nivolumab in R/M HNSCC

Terminated Phase 1 Last updated 9 April 2024

What this trial tests

Phase 1 trial testing CMAB819 in Squamous Cell Carcinoma of the Head and Neck in 21 participants. Terminated before completion.

Timeline

24 September 2020

Primary endpoint
16 October 2023

16 October 2023

Quick facts

Lead sponsor	Taizhou Mabtech Pharmaceutical Co.,Ltd
Phase	Phase 1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	21
Start date	24 September 2020
Primary completion	16 October 2023
Estimated completion	16 October 2023
Sites	1 location across China

Drugs / interventions tested

CMAB819 — full drug profile →
Nivolumab (nivolumab) — 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

Taizhou Mabtech Pharmaceutical Co.,Ltd — full company profile →

Who can join

Adults 18 to 75, any sex, with Squamous Cell Carcinoma of the Head and Neck. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of this study is to compare the pharmacokinetic, safety, immunogenicity and efficacy of CMAB819 and Nivolumab in subjects with recurrent or metastatic head and neck squamous cell carcinoma., after failure of prior platinum-based chemotherapy.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Monoclonal antibody biosimilars for cancer treatment.
Broer LN, Knapen DG, de Groot DA, Mol PGM, et al · · 2024 · cited 4× · PMID 38974466 · DOI 10.1016/j.isci.2024.110115

Verify or expand the search:

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 Taizhou Mabtech Pharmaceutical Co.,Ltd trials

Trials by the same sponsor.

NCT07254325 — Pharmacokinetic, Safety and Immunogenicity Study of New Process CMAB015 and Cosentyx in Healthy Volunteers · Phase 1 · not yet recruiting
NCT07246291 — Comparative Study of EnliTuo® Before and After Technology Change in Healthy Male Volunteers · Phase 1 · recruiting
NCT06933069 — Safety and Tolerability of CMAB017 In Patients With Advanced Solid Tumors · Phase 1 · recruiting
NCT06398652 — Comparative Study of CMAB015 and Secukinumab for Patients With Moderate to Severe Plaque Psoriasis · Phase 3 · active not recruiting
NCT06365879 — To Compare Efficacy and Safety of CMAB007 and Xolair® in Patients With Chronic Spontaneous Urticaria · Phase 3 · 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 NCT04659369 (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 Taizhou Mabtech Pharmaceutical Co.,Ltd
Last refreshed: 9 April 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/NCT04659369.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing