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Molecular Residual Disease Interception in Locoregionally-Advanced High Risk HPV+ and HPV- HNSCC

NCT05414032 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 102

Last updated 2026-02-25

No results posted yet for this study

Summary

This is a phase II, open-label study to assess the efficacy of AZD2936 in terms of molecular residual disease (MRD) clearance and treatment outcome in patients with MRD after definitive treatment for high risk locoregionally advanced head and neck squamous cell carcinoma (LA-HNSCC). MRD is defined as ctDNA detection in plasma after definitive treatment. Approximately 100 patients are expected to be enrolled.

Conditions

  • Locoregionally Advanced Head and Neck Squamous Cell Carcinoma (LA-HNSCC)

Interventions

BIOLOGICAL

AZD2936

AZD2936 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.

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • NeoGenomics Laboratories, Inc.

    collaborator UNKNOWN

  • Personalis Inc.

    collaborator INDUSTRY

  • University Health Network, Toronto

    lead OTHER

Principal Investigators

  • Lillian Siu, MD · Princess Margaret Cancer Centre

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-12
Primary Completion
2027-09-30
Completion
2028-07-31

Countries

  • Canada

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05414032 on ClinicalTrials.gov