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
Who is this study for? Patients with advanced or metastatic non-small cell lung cancer
What treatments are being studied? AZD2936
Status: Recruiting
Location: See all (48) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 130
Healthy Volunteers: f
View:
• 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
Locations
United States
California
Research Site
WITHDRAWN
Orange
Illinois
Research Site
RECRUITING
Chicago
Maryland
Research Site
WITHDRAWN
Baltimore
Minnesota
Research Site
RECRUITING
Rochester
Texas
Research Site
WITHDRAWN
Houston
Virginia
Research Site
RECRUITING
Fairfax
Other Locations
Australia
Research Site
COMPLETED
Melbourne
Belgium
Research Site
RECRUITING
Anderlecht
Research Site
RECRUITING
Leuven
Brazil
Research Site
RECRUITING
Florianópolis
Research Site
RECRUITING
Natal
Research Site
RECRUITING
Porto Alegre
Research Site
RECRUITING
Rio De Janeiro
Research Site
RECRUITING
São Paulo
China
Research Site
RECRUITING
Chengdu
Research Site
ACTIVE_NOT_RECRUITING
Chongqing
Research Site
WITHDRAWN
Wuhan
Denmark
Research Site
ACTIVE_NOT_RECRUITING
Copenhagen
France
Research Site
RECRUITING
Dijon
Research Site
RECRUITING
Toulouse
Georgia
Research Site
RECRUITING
Tbilisi
Japan
Research Site
RECRUITING
Kashiwa
Research Site
RECRUITING
Niigata
Research Site
RECRUITING
Sendai
Research Site
RECRUITING
Tokyo
Malaysia
Research Site
RECRUITING
Kuala Lumpur
Research Site
RECRUITING
Kuching
Netherlands
Research Site
RECRUITING
Groningen
Research Site
RECRUITING
Leiden
Research Site
COMPLETED
Utrecht
Republic of Korea
Research Site
RECRUITING
Seoul
Research Site
RECRUITING
Seoul
Research Site
RECRUITING
Seoul
Republic of Moldova
Research Site
RECRUITING
Chisinau
Singapore
Research Site
WITHDRAWN
Singapore
Spain
Research Site
ACTIVE_NOT_RECRUITING
Barcelona
Research Site
ACTIVE_NOT_RECRUITING
Madrid
Research Site
ACTIVE_NOT_RECRUITING
Madrid
Taiwan
Research Site
RECRUITING
Taichung
Research Site
RECRUITING
Taichung
Research Site
RECRUITING
Tainan City
Research Site
RECRUITING
Taipei
Research Site
WITHDRAWN
Taipei
Thailand
Research Site
RECRUITING
Bangkok
Research Site
RECRUITING
Chanthaburi
Research Site
RECRUITING
Muang
United Kingdom
Research Site
WITHDRAWN
Leicester
Research Site
WITHDRAWN
Manchester
Contact Information
Primary
AstraZeneca Clinical Study Information Center
information.center@astrazeneca.com
1-877-240-9479
Time Frame
Start Date:2021-09-14
Estimated Completion Date:2028-03-16
Participants
Target number of participants:210
Treatments
Experimental: Dose Escalation Part A: Checkpoint inhibitor (CPI) experienced Non-small Cell Lung Cancer (NSCLC)
Rilvegostomig Intravenous (IV) monotherapy
Experimental: Dose Expansion Part B: CPI experienced NSCLC
Rilvegostomig IV monotherapy
Experimental: Dose Expansion Part C: CPI Naive NSCLC
Rilvegostomig IV monotherapy
Experimental: Dose Expansion Part D: CPI Naive NSCLC
Rilvegostomig IV monotherapy
Experimental: Dose Expansion Part E: treatment Naive Squamous NSCLC