CLINICAL TRIAL / NCT04995523

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

Interventional
Recruiting
NCT04995523

Eligibility Details Visit Clinicaltrials.gov

Contact Information

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

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.

Detailed Description

Eligibility Details

Gender
All

Age Group
18 Years to 130 Years

Accepting Healthy Volunteers
No

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. - 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. - ECOG performance status of 0 or 1 at enrolment. - Life expectancy of â‰¥ 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. - Primary or secondary resistance after treatment with 2 or more regimens including a CPI. - Symptomatic central nervous system (CNS) metastasis. - Thromboembolic event within 3 months prior to enrolment. - Other invasive malignancy within 2 years prior to screening.