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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04995523




Registration number
NCT04995523
Ethics application status
Date submitted
16/07/2021
Date registered
9/08/2021
Date last updated
23/04/2024

Titles & IDs
Public title
A Study of AZD2936 Anti-TIGIT/Anti-PD-1 Bispecific Antibody in Participants With Advanced or Metastatic NSCLC
Scientific title
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
Secondary ID [1] 0 0
2021-000857-23
Secondary ID [2] 0 0
D7020C00001
Universal Trial Number (UTN)
Trial acronym
ARTEMIDE-01
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-Small-Cell Lung Carcinoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Non small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - AZD2936

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


Treatment: Drugs: AZD2936
Anti-TIGIT/Anti-PD-1 Bispecific Antibody
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of participants with adverse events (AEs) and immune mediated AEs (imAEs), serious AEs (SAEs), dose limiting toxicities (DLTs), vital signs, and abnormal laboratory parameters
Timepoint [1] 0 0
Part A, B, C and D: From the time of informed consent until 90 days after the last dose of rilvegostomig
Primary outcome [2] 0 0
Rate of rilvegostomig discontinuation due to toxicity
Timepoint [2] 0 0
Part A, B, C and D: From first dose to the last dose of rilvegostomig (an average of 6 months)
Primary outcome [3] 0 0
Objective Response Rate (ORR)
Timepoint [3] 0 0
Part B, C and D: From first dose of rilvegostomig to progressive disease (PD) or death in the absence of disease progression (approximately 2 years)
Secondary outcome [1] 0 0
ORR
Timepoint [1] 0 0
Part A: From first dose of rilvegostomig to PD or death in the absence of disease progression (approximately 2 years).
Secondary outcome [2] 0 0
Disease control rate (DCR)
Timepoint [2] 0 0
Part A, B, C: From first dose of rilvegostomig to PD or death in the absence of disease progression (approximately 2 years). Part D: From randomization to PD or death in the absence of disease progression (approximately 2 years).
Secondary outcome [3] 0 0
Duration of response (DoR)
Timepoint [3] 0 0
Part A, B, C and D: From first dose of rilvegostomig to PD or death in the absence of disease progression (approximately 2 years).
Secondary outcome [4] 0 0
Durable response rate (DRR)
Timepoint [4] 0 0
Part A, B, C and D: From first dose of rilvegostomig to PD or death in the absence of disease progression (approximately 2 years).
Secondary outcome [5] 0 0
Progression-free survival (PFS)
Timepoint [5] 0 0
Part B, C: From first dose of rilvegostomig to PD or death in the absence of disease progression (approximately 2 years). Part D: From randomization to PD or death in the absence of disease progression (approximately 2 years).
Secondary outcome [6] 0 0
Measure the receptor occupancy (RO) of TIGIT and PD-1 on peripheral blood
Timepoint [6] 0 0
Part A, B: From first dose of study intervention, at predefined intervals throughout the administration of rilvegostomig (approximately 2 years). The predefined intervals for Part A will be different from Part B.
Secondary outcome [7] 0 0
PK of rilvegostomig: Maximum plasma concentration of the study drug (Cmax)
Timepoint [7] 0 0
From first dose of study intervention, at predefined intervals throughout the administration of rilvegostomig (approximately 2 years). The predefined intervals for Part A will be different from Part B, C and D.
Secondary outcome [8] 0 0
PK of rilvegostomig: Area under the concentration-time curve (AUC)
Timepoint [8] 0 0
From first dose of study intervention, at predefined intervals throughout the administration of rilvegostomig (approximately 2 years). The predefined intervals for Part A will be different from Part B, C and D.
Secondary outcome [9] 0 0
PK of rilvegostomig: Clearance
Timepoint [9] 0 0
From first dose of study intervention, at predefined intervals throughout the administration of rilvegostomig (approximately 2 years). The predefined intervals for Part A will be different from Part B, C and D.
Secondary outcome [10] 0 0
PK of rilvegostomig: Terminal elimination half-life (t 1/2)
Timepoint [10] 0 0
From first dose of study intervention, at predefined intervals throughout the administration of rilvegostomig (approximately 2 years). The predefined intervals for Part A will be different from Part B, C and D.
Secondary outcome [11] 0 0
Incidence of anti-drug antibodies (ADA) against rilvegostomig in serum
Timepoint [11] 0 0
From first dose of study intervention, at predefined intervals throughout the administration of rilvegostomig (approximately 2 years). The predefined intervals for Part A will be different from Part B, C and D.

Eligibility
Key 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 = 12 weeks at enrolment.

- Have at least 1 measurable lesion per RECIST v1.1.

- Adequate bone marrow, liver and kidney function
Minimum age
18 Years
Maximum age
130 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1/Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
14/09/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
27/11/2025
Actual
Sample size
Target
Accrual to date
Final
179
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Melbourne
Recruitment postcode(s) [1] 0 0
3000 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Illinois
Country [2] 0 0
United States of America
State/province [2] 0 0
Minnesota
Country [3] 0 0
United States of America
State/province [3] 0 0
Virginia
Country [4] 0 0
Belgium
State/province [4] 0 0
Anderlecht
Country [5] 0 0
Belgium
State/province [5] 0 0
Leuven
Country [6] 0 0
Brazil
State/province [6] 0 0
Florianópolis
Country [7] 0 0
Brazil
State/province [7] 0 0
Natal
Country [8] 0 0
Brazil
State/province [8] 0 0
Porto Alegre
Country [9] 0 0
Brazil
State/province [9] 0 0
Rio de Janeiro
Country [10] 0 0
Brazil
State/province [10] 0 0
Sao Paulo
Country [11] 0 0
China
State/province [11] 0 0
Chengdu
Country [12] 0 0
China
State/province [12] 0 0
Chongqing
Country [13] 0 0
Denmark
State/province [13] 0 0
Copenhagen
Country [14] 0 0
France
State/province [14] 0 0
Dijon
Country [15] 0 0
France
State/province [15] 0 0
Toulouse Cedex 09
Country [16] 0 0
Japan
State/province [16] 0 0
Kashiwa
Country [17] 0 0
Japan
State/province [17] 0 0
Niigata-shi
Country [18] 0 0
Japan
State/province [18] 0 0
Sendai-shi
Country [19] 0 0
Japan
State/province [19] 0 0
Tokyo
Country [20] 0 0
Korea, Republic of
State/province [20] 0 0
Seoul
Country [21] 0 0
Malaysia
State/province [21] 0 0
Kuala Lumpur
Country [22] 0 0
Malaysia
State/province [22] 0 0
Kuching
Country [23] 0 0
Netherlands
State/province [23] 0 0
Groningen
Country [24] 0 0
Netherlands
State/province [24] 0 0
Leiden
Country [25] 0 0
Netherlands
State/province [25] 0 0
Utrecht
Country [26] 0 0
Spain
State/province [26] 0 0
Barcelona
Country [27] 0 0
Spain
State/province [27] 0 0
Madrid
Country [28] 0 0
Taiwan
State/province [28] 0 0
Taichung
Country [29] 0 0
Taiwan
State/province [29] 0 0
Tainan City
Country [30] 0 0
Taiwan
State/province [30] 0 0
Taipei City
Country [31] 0 0
Thailand
State/province [31] 0 0
Bangkok
Country [32] 0 0
Thailand
State/province [32] 0 0
Muang
Country [33] 0 0
Thailand
State/province [33] 0 0
Mueang Chanthaburi

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
AstraZeneca
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04995523
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04995523