A Study of AZD2936 Anti-TIGIT/Anti-PD-1 Bispecific Antibody in Participants With Advanced or Metastatic NSCLC

Description

This is a Phase I/II study designed to evaluate if experimental anti-TIGIT/anti-PD-1 bispecific antibody rilvegostomig (AZD2936) is safe, tolerable and efficacious in participants with Advanced or Metastatic Non-small Cell Lung Cancer.

Conditions

Non-Small-Cell Lung Carcinoma

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Study Overview

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Study Details

Study overview

This is a Phase I/II study designed to evaluate if experimental anti-TIGIT/anti-PD-1 bispecific antibody rilvegostomig (AZD2936) is safe, tolerable and efficacious in participants with Advanced or Metastatic Non-small Cell Lung Cancer.

Phase I/II, Open-label, Dose Escalation and Dose Expansion Study to Evaluate Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of AZD2936 Anti-TIGIT/Anti-PD-1 Bispecific Antibody in Participants With Advanced or Metastatic NSCLC

A Study of AZD2936 Anti-TIGIT/Anti-PD-1 Bispecific Antibody in Participants With Advanced or Metastatic NSCLC

Condition
Non-Small-Cell Lung Carcinoma
Intervention / Treatment

-

Contacts and Locations

Orange

Research Site, Orange, California, United States, 92868

Chicago

Research Site, Chicago, Illinois, United States, 60637

Baltimore

Research Site, Baltimore, Maryland, United States, 21201

Rochester

Research Site, Rochester, Minnesota, United States, 55905

Houston

Research Site, Houston, Texas, United States, 77030

Fairfax

Research Site, Fairfax, Virginia, United States, 22031

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Written informed consent
  • * Aged 18 or above
  • * Part A and Part B: Unresectable stage III or stage IV squamous or non-squamous NSCLC not amenable to curative surgery or radiation. Part C and Part D: Stage IV squamous or non-squamous NSCLC not amenable to curative surgery or radiation. Part E: Stage IV squamous NSCLC not amenable to curative surgery or radiation.
  • * Documented PD-L1 expression by PD-L1 IHC per local report.
  • * Part A and Part B: Confirmed progression during treatment with a CPI-including regimen.
  • * Part C and Part D: No prior I/O treatment for metastatic NSCLC.
  • * Part E: No prior treatment for metastatic NSCLC.
  • * ECOG performance status of 0 or 1 at enrolment.
  • * Life expectancy of ≥ 12 weeks at enrolment.
  • * Have at least 1 measurable lesion per RECIST v1.1.
  • * Adequate bone marrow, liver and kidney function
  • * Sensitizing epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) fusion
  • * Documented test result for any other known genomic alteration for which a targeted therapy is approved in first line per local standard of care (e.g. ROS1, NTRK fusions, BRAF, V600E mutation)
  • * Previous treatment with an anti-TIGIT therapy
  • * Any concurrent chemotherapy, radiotherapy, investigational, biologic, or hormonal therapy for cancer treatment.
  • * Part A and Part B: Primary or secondary resistance after treatment with 2 or more regiments including a CPI.
  • * Part C and Part D: Any prior systemic treatment with an immune oncology agent (prior administration of immune-oncology agent for curative intent to treat other invasive malignancy is permitted).
  • * Part E: Any prior systemic treatment for metastatic NSCLC, including but not limited to chemotherapy, anti-PD-1, anti-PD-L1, anti-CTLA-4.
  • * Symptomatic central nervous system (CNS) metastasis.
  • * Thromboembolic event within 3 months prior to enrolment.
  • * Other invasive malignancy within 2 years prior to screening.

Ages Eligible for Study

18 Years to 130 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

AstraZeneca,

Study Record Dates

2028-03-16