RecruitingPhase 1Phase 2NCT04995523
A Study of AZD2936 Anti-TIGIT/Anti-PD-1 Bispecific Antibody in Participants With Advanced or Metastatic NSCLC
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
Sponsor
AstraZeneca
Enrollment
210 participants
Start Date
Sep 14, 2021
Study Type
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Min Age: 18 YearsMax Age: 130 Years
Inclusion Criteria11
- 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 Criteria11
- 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.
Interventions
DRUGAZD2936
Anti-TIGIT/Anti-PD-1 Bispecific Antibody
Locations(48)
View Full Details on ClinicalTrials.gov
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NCT04995523