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AZD2936

Phase 2

Locoregionally Advanced Head and Neck Squamous Cell Carcinoma (LA-HNSCC) | Monoclonal antibody | Oncology |NeoGenomics, Inc.|Last Updated: Feb 25, 2026

Success Probability

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Trial Design

RandomizedNO_TREATMENT_CONTROLLEDDMC
Total Trials1
Total Enrollment102

FDA Designations

No designations recorded

Clinical trial landscape

AZD2936 · 1 trial · 1 indication

Phase 2 1
NCT05414032Molecular Residual Disease Interception in Locoregionally-Advanced High Risk HPV+ and HPV- HNSCCLocoregionally Advanced Head and Neck Squamous Cell Carcinoma (LA-HNSCC)
RECRUITING102 Analytics
PHASE2RECRUITING
Molecular Residual Disease Interception in Locoregionally-Advanced High Risk HPV+ and HPV- HNSCC
Locoregionally Advanced Head and Neck Squamous Cell Carcinoma (LA-HNSCC)
NCT05414032102
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Study Endpoints

Primary Endpoints

Efficacy (in terms of ctDNA clearance) of AZD2936 compared to observation (Standard of Care, SOC) in LA-HNSCC patients who have MRD (MRD+) after definitive treatment.
3 years

Clearance of bespoke ctDNA at different time points (week 2 and week 10 after the end of MRD treatment). ctDNA clearance is defined as no detection of ctDNA in both of these two consecutive determinations.

Secondary Endpoints

Efficacy (in terms of delaying or preventing radiological recurrence of disease or death) of AZD2936 compared to observation (SOC) in MRD+ LA-HNSCC patients after definitive treatment.
3 years
Efficacy (in terms of MRD control) of AZD2936 compared to observation (SOC) in MRD+ LA-HNSCC patients after definitive treatment.
3 years
Efficacy (in terms of median DFS and OS) of AZD2936 compared to observation (SOC) in MRD+ LA-HNSCC patients after definitive treatment.
3 years
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
MRD positive and/or radiological/clinical progression CohortEXPERIMENTALDose formulation- AZD2936 is supplied as a liquid drug product in a 20R vial containing 750 mg (nominal) of active AZD2936. The solution contains 50 mg/mL AZD2936 in 20 mM L-histidine/L- histidine-hydrochloride, 240 mM sucrose, 0.04% (w/v) poloxamer 188, at pH 6.0. Unit dose strength(s)- 750 mg/vial (50 mg/mL) Dosage levels- 750mg administered Q3W Route of administration- IV infusion over 1 hour
MRD negative CohortNO_INTERVENTIONObservation

Interventions

NameTypeDescription
AZD2936BIOLOGICALAZD2936 is a monovalent, bispecific, humanized, IgG1 triple mutant mAb antibody against human PD 1 and TIGIT. AZD2936 was constructed on the backbone of the DuetMab molecule (Mazor et al., 2015), and its antigen binding fragment portions are comprised of the variable domains of the anti TIGIT COM902 antibody and anti PD 1 LO115 antibody. The IgG1 Fc domain carries the triple mutation (L234F/L235E/P331S) designed to reduce Fc mediated immune effector functions. In the preclinical studies, dual blockade of TIGIT and PD 1 by AZD2936 enhanced human T cell function and promoted antitumor immune responses.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria for All Parts 1. Age ≥ 18 years at the time of screening or age of consent according to law. 2. Written informed consent and any locally required authorization (e.g., data privacy) obtained from the subject prior to performing any protocol-related procedures, including screening ...

Countries:Canada
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Frequently asked questions about AZD2936

What is AZD2936 used for in Locoregionally Advanced Head and Neck Squamous Cell Carcinoma (LA-HNSCC)?

AZD2936 is a monoclonal antibody being studied for the treatment of Locoregionally Advanced Head and Neck Squamous Cell Carcinoma (LA-HNSCC). It is currently in Phase 2 clinical development as an investigational therapy. The drug is being evaluated in a randomized trial for patients with this condition.

Who makes AZD2936?

AZD2936 is being developed by NeoGenomics, Inc., a company traded on the stock exchange under the ticker symbol NEO. The company is conducting clinical research on this monoclonal antibody for the treatment of Locoregionally Advanced Head and Neck Squamous Cell Carcinoma (LA-HNSCC).

What phase is AZD2936 in?

AZD2936 is in Phase 2 clinical development. It is an investigational monoclonal antibody being studied for Locoregionally Advanced Head and Neck Squamous Cell Carcinoma (LA-HNSCC). The drug is not yet approved and is currently being evaluated in an active clinical trial.

What clinical trials is AZD2936 in?

AZD2936 is being studied in clinical trial NCT05414032, titled "Molecular Residual Disease Interception in Locoregionally-Advanced High Risk HPV+ and HPV- HNSCC." This Phase 2 trial is recruiting participants in Canada and has an enrollment target of 102 patients. The trial is randomized and does not use a double-blind design.

Is AZD2936 FDA approved?

AZD2936 is not FDA approved. It is an investigational monoclonal antibody currently in Phase 2 clinical development for Locoregionally Advanced Head and Neck Squamous Cell Carcinoma (LA-HNSCC). The drug is being evaluated in an active clinical trial and has not yet received regulatory approval.

How does AZD2936 work?

AZD2936 is a monoclonal antibody, a type of drug designed to target specific proteins involved in disease. As a monoclonal antibody, it works by binding to its target to modulate the immune system's response against cancer cells. The specific molecular target of AZD2936 has not been disclosed.