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

Sponsor: AstraZeneca

Sponsor score: 40

ClinicalTrials ID:NCT04995523

This Phase I/II open-label study evaluates the safety, PK, pharmacodynamics, and efficacy of rilvegostomig (AZD2936) in adults with advanced NSCLC. Participants must have documented PD-L1 expression, an ECOG status of 0 or 1, and a life expectancy of ≥12 weeks. The study includes dose escalation and expansion phases, requiring measurable lesions and adequate organ function.

Patient Parameters

Program 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.

Description

This is a first-time-in-human (FTIH), open-label, multicenter, multi-part, dose-escalation and dose-expansion study to evaluate the safety, pharmacokinetics (PK), pharmacodynamics, and efficacy of rilvegostomig (AZD2936) in adult participants with stage III unresectable or stage IV NSCLC. The study includes 4 parts: Part A (dose escalation) and Parts B-E (dose expansion).

Eligibility Criteria

Inclusion 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

Exclusion Criteria

  • 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).

Treatment with one previous systemic chemotherapy will be allowed.

  • 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.

Locations

FACILITYZIPCITYSTATE
Research Site92868OrangeCalifornia
Research Site60637ChicagoIllinois
Research Site21201BaltimoreMaryland
Research Site55905RochesterMinnesota
Research Site77030HoustonTexas
Research Site22031FairfaxVirginia

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