Página de ensayos clínicos Nct

Summary
EudraCT Number:2021-000857-23
Sponsor's Protocol Code Number:D7020C00001
National Competent Authority:Denmark - DHMA
Clinical Trial Type:EEA CTA
Trial Status:Trial now transitioned
Date on which this record was first entered in the EudraCT database:2021-06-23
Trial results
Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL
A. Protocol Information
A.1Member State ConcernedDenmark - DHMA
A.2EudraCT number2021-000857-23
A.3Full title of the trial
A Phase I/II, Open-label, Dose Escalation and Dose Expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of AZD2936 Anti TIGIT/Anti-PD-1 Bispecific Antibody in Participants with Advanced or Metastatic Non small Cell Lung Cancer (ARTEMIDE-01)
A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
A Study of AZD2936 Anti-TIGIT/Anti-PD-1 Bispecific Antibody in Participants with Advanced or Metastatic Non-small Cell Lung Cancer
A.3.2Name or abbreviated title of the trial where available
ARTEMIDE-01
A.4.1Sponsor's protocol code numberD7020C00001
A.7Trial is part of a Paediatric Investigation Plan No
A.8EMA Decision number of Paediatric Investigation Plan
B. Sponsor Information
B.Sponsor: 1
B.1.1Name of SponsorAstraZeneca AB
B.1.3.4CountrySweden
B.3.1 and B.3.2Status of the sponsorCommercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1Name of organisation providing supportAstraZeneca AB
B.4.2CountrySweden
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1Name of organisationAstraZeneca
B.5.2Functional name of contact pointClinical Study Information Center
B.5.3 Address:
B.5.3.1Street Address1800 Concorde Pike
B.5.3.2Town/ cityWilmington
B.5.3.3Post codeDE 19803
B.5.3.4CountryUnited States
B.5.6E-mailInformation.Center@astrazeneca.com
D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3IMP RoleTest
D.2 Status of the IMP to be used in the clinical trial
D.2.1IMP to be used in the trial has a marketing authorisation No
D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
D.2.5.1Orphan drug designation number
D.3 Description of the IMP
D.3.1Product nameAZD2936
D.3.2Product code AZD2936
D.3.4Pharmaceutical form Powder for concentrate for solution for infusion
D.3.4.1Specific paediatric formulation No
D.3.7Routes of administration for this IMPIntravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8INN - Proposed INNrilvegostomig
D.3.9.1CAS number 2640305-01-5
D.3.9.2Current sponsor codeAZD2936
D.3.9.3Other descriptive nameMonovalent bispecific humanized IgG1 antibody
D.3.10 Strength
D.3.10.1Concentration unit mg milligram(s)
D.3.10.2Concentration typeequal
D.3.10.3Concentration number250
D.3.11 The IMP contains an:
D.3.11.1Active substance of chemical origin No
D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
The IMP is a:
D.3.11.3Advanced Therapy IMP (ATIMP) No
D.3.11.3.1Somatic cell therapy medicinal product No
D.3.11.3.2Gene therapy medical product No
D.3.11.3.3Tissue Engineered Product No
D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
D.3.11.5Radiopharmaceutical medicinal product No
D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
D.3.11.7Plasma derived medicinal product No
D.3.11.8Extractive medicinal product No
D.3.11.9Recombinant medicinal product Yes
D.3.11.10Medicinal product containing genetically modified organisms No
D.3.11.11Herbal medicinal product No
D.3.11.12Homeopathic medicinal product No
D.3.11.13Another type of medicinal product No
D.IMP: 2
D.1.2 and D.1.3IMP RoleTest
D.2 Status of the IMP to be used in the clinical trial
D.2.1IMP to be used in the trial has a marketing authorisation No
D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
D.2.5.1Orphan drug designation number
D.3 Description of the IMP
D.3.1Product nameAZD2936
D.3.2Product code AZD2936
D.3.4Pharmaceutical form Concentrate for solution for infusion
D.3.4.1Specific paediatric formulation No
D.3.7Routes of administration for this IMPIntravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8INN - Proposed INNrilvegostomig
D.3.9.1CAS number 2640305-01-5
D.3.9.2Current sponsor codeAZD2936
D.3.9.3Other descriptive nameMonovalent bispecific humanized IgG1 antibody
D.3.10 Strength
D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
D.3.10.2Concentration typeequal
D.3.10.3Concentration number50
D.3.11 The IMP contains an:
D.3.11.1Active substance of chemical origin No
D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
The IMP is a:
D.3.11.3Advanced Therapy IMP (ATIMP) No
D.3.11.3.1Somatic cell therapy medicinal product No
D.3.11.3.2Gene therapy medical product No
D.3.11.3.3Tissue Engineered Product No
D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
D.3.11.5Radiopharmaceutical medicinal product No
D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
D.3.11.7Plasma derived medicinal product No
D.3.11.8Extractive medicinal product No
D.3.11.9Recombinant medicinal product Yes
D.3.11.10Medicinal product containing genetically modified organisms No
D.3.11.11Herbal medicinal product No
D.3.11.12Homeopathic medicinal product No
D.3.11.13Another type of medicinal product No
D.8 Information on Placebo
E. General Information on the Trial
E.1 Medical condition or disease under investigation
E.1.1Medical condition(s) being investigated
Advanced Non-small Cell Lung Cancer, Metastatic Non-small Cell Lung Cancer, stage III unresectable Non-small Cell Lung Cancer (Protocol Parts A-B), stage IV Non-small Cell Lung Cancer (Protocol Parts A-D).
E.1.1.1Medical condition in easily understood language
Non-small Cell Lung Cancer, which is either localized but too big to be removed by surgery (Protocol Parts A-B) or has already spread throughout the body (Protocol Parts A-D).
E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
MedDRA Classification
E.1.2 Medical condition or disease under investigation
E.1.2Version 20.1
E.1.2Level LLT
E.1.2Classification code 10080083
E.1.2Term Advanced lung cancer
E.1.2System Organ Class 100000004864
E.1.3Condition being studied is a rare disease No
E.2 Objective of the trial
E.2.1Main objective of the trial
Evaluate the safety, PK, pharmacodynamics, and efficacy of rilvegostomig in adult participants with stage III unresectable or stage IV NSCLC.
E.2.2Secondary objectives of the trial
To assess the immunogenicity of rilvegostomig and to assess the PK profile compatibility of rilvegostomig in 2L+ CPI experienced and 1L CPI naïve participants with stage III/IV unresectable NSCLC.
E.2.3Trial contains a sub-study No
E.3Principal 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.
- Confirmed progression during treatment with a CPI-including regimen
(Part A, Part B).
- No prior IO treatment for metastatic NSCLC (Part C, Part D).
- 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.
E.4Principal 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 regimens 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.
- Symptomatic central nervous system (CNS) metastasis.
- Thromboembolic event within 3 months prior to enrolment.
- Other invasive malignancy within 2 years prior to screening.
E.5 End points
E.5.1Primary end point(s)
Part A:
- Safety and tolerability of rilvegostomig, assessed by the percentage of patients with adverse events, immune-mediated adverse events and dose-limiting toxicities as well as the rate of discontinuation of rilvegostomig due to toxicity.

Part B and Part C:
- Safety and tolerability of rilvegostomig at the recommended Phase II dose, assessed by the percentage of patients with adverse events, immune-mediated adverse events and dose-limiting toxicity-like events as well as the rate of discontinuation of rilvegostomig due to toxicity.
- Preliminary anti-tumour activity of rilvegostomig, assessed by objective response rate (ORR) according to RECIST 1.1

Part D:
-Safety and tolerability of rilvegostomig at the recommended Phase II dose and a higher dose, assessed by the percentage of patients with adverse events, immune-mediated adverse events and dose-limiting toxicity-like events as well as the rate of discontinuation of rilvegostomig due to toxicity.
- Preliminary anti-tumour activity of rilvegostomig, assessed by objective response rate (ORR) according to RECIST 1.1

All parts of study: Vital signs and abnormal laboratory parameters
E.5.1.1Timepoint(s) of evaluation of this end point
Safety: from time of informed consent until 90 days after the last dose of study intervention.
Efficacy: from first dose of study intervention to progressive disease or death (in absence of disease progression).
E.5.2Secondary end point(s)
Part A:
- Preliminary anti-tumour activity of rilvegostomig, assessed by objective response rate (ORR), disease control rate (DCR), duration of response (DoR) and durable response rate (DRR) according to RECIST 1.1
- Target engagement of rilvegostomig in peripheral blood, assessed by TIGIT and PD-1 receptor occupancy (RO) on peripheral blood T cells
Part B:
- Preliminary anti-tumour activity of rilvegostomig at the recommended Phase II dose, assessed by disease control rate (DCR), duration of response (DoR), durable response rate (DRR) and progression-free survival (PFS) according to RECIST 1.1
- Target engagement of rilvegostomig in peripheral blood, assessed by TIGIT and PD-1 receptor occupancy (RO) on peripheral blood T cells

Part C:
- Preliminary anti-tumour activity of rilvegostomig at the recommended Phase II dose, assessed by disease control rate (DCR), duration of response (DoR), durable response rate (DRR) and progression-free survival (PFS) according to RECIST 1.1

Part D:
- Preliminary anti-tumour activity of rilvegostomig at the recommended Phase II dose and a higher dose, assessed by disease control rate (DCR), duration of response (DoR), durable response rate (DRR) and progression-free survival (PFS) according to RECIST 1.1

All parts of study:
- PK profile compatibility of rilvegostomig with the study dosing schedule in patients with stage III/IV unresectable NSCLC, assessed by serum concentrations, PK parameters (Cmax, AUC, clearance, etc.)
- Immunogenicity of rilvegostomig, assessed by the incidence of ADAs against rilvegostomig in serum
E.5.2.1Timepoint(s) of evaluation of this end point
Safety: from time of informed consent until 90 days after the last dose of study intervention.
Efficacy: For Part A, B and C, from first dose of study intervention to progressive disease or death (in absence of disease progression) ; For Part D, from randomization to progressive disease or death (in absence of disease progression)
E.6 and E.7 Scope of the trial
E.6Scope of the trial
E.6.1Diagnosis No
E.6.2Prophylaxis No
E.6.3Therapy Yes
E.6.4Safety Yes
E.6.5Efficacy Yes
E.6.6Pharmacokinetic Yes
E.6.7Pharmacodynamic Yes
E.6.8Bioequivalence No
E.6.9Dose response Yes
E.6.10Pharmacogenetic No
E.6.11Pharmacogenomic No
E.6.12Pharmacoeconomic No
E.6.13Others No
E.7Trial type and phase
E.7.1Human pharmacology (Phase I) Yes
E.7.1.1First administration to humans Yes
E.7.1.2Bioequivalence study No
E.7.1.3Other No
E.7.1.3.1Other trial type description
E.7.2Therapeutic exploratory (Phase II) Yes
E.7.3Therapeutic confirmatory (Phase III) No
E.7.4Therapeutic use (Phase IV) No
E.8 Design of the trial
E.8.1Controlled No
E.8.1.1Randomised Yes
E.8.1.2Open Yes
E.8.1.3Single blind No
E.8.1.4Double blind No
E.8.1.5Parallel group Information not present in EudraCT
E.8.1.6Cross over No
E.8.1.7Other Yes
E.8.1.7.1Other trial design description
Part A: Dose escalation; B & C: Dose expansion non-randomized; D: Randomized RP2D & alternative dose
E.8.2 Comparator of controlled trial
E.8.2.1Other medicinal product(s) No
E.8.2.2Placebo Information not present in EudraCT
E.8.2.3Other Information not present in EudraCT
E.8.2.4Number of treatment arms in the trial12
E.8.3 The trial involves single site in the Member State concerned Yes
E.8.4 The trial involves multiple sites in the Member State concerned No
E.8.5The trial involves multiple Member States Yes
E.8.5.1Number of sites anticipated in the EEA11
E.8.6 Trial involving sites outside the EEA
E.8.6.1Trial being conducted both within and outside the EEA Yes
E.8.6.2Trial being conducted completely outside of the EEA No
E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
Malaysia
Singapore
Taiwan
Australia
Brazil
China
Japan
Korea, Republic of
Thailand
United States
Belgium
Denmark
France
Netherlands
Spain
E.8.7Trial has a data monitoring committee No
E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
The end of the study is defined as the date of the last visit of the last participant in the study or last scheduled procedure shown in the SoA for the last participant in the study globally.
E.8.9 Initial estimate of the duration of the trial
E.8.9.1In the Member State concerned years2
E.8.9.1In the Member State concerned months2
E.8.9.1In the Member State concerned days
E.8.9.2In all countries concerned by the trial years2
E.8.9.2In all countries concerned by the trial months2
F. Population of Trial Subjects
F.1 Age Range
F.1.1Trial has subjects under 18 No
F.1.1.1In Utero No
F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
F.1.1.3Newborns (0-27 days) No
F.1.1.4Infants and toddlers (28 days-23 months) No
F.1.1.5Children (2-11years) No
F.1.1.6Adolescents (12-17 years) No
F.1.2Adults (18-64 years) Yes
F.1.2.1Number of subjects for this age range: 96
F.1.3Elderly (>=65 years) Yes
F.1.3.1Number of subjects for this age range: 96
F.2 Gender
F.2.1Female Yes
F.2.2Male Yes
F.3 Group of trial subjects
F.3.1Healthy volunteers No
F.3.2Patients Yes
F.3.3Specific vulnerable populations Yes
F.3.3.1Women of childbearing potential not using contraception No
F.3.3.2Women of child-bearing potential using contraception Yes
F.3.3.3Pregnant women No
F.3.3.4Nursing women No
F.3.3.5Emergency situation No
F.3.3.6Subjects incapable of giving consent personally No
F.3.3.7Others No
F.4 Planned number of subjects to be included
F.4.1In the member state3
F.4.2 For a multinational trial
F.4.2.1In the EEA 80
F.4.2.2In the whole clinical trial 192
F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
None
G. Investigator Networks to be involved in the Trial
N. Review by the Competent Authority or Ethics Committee in the country concerned
N.Competent Authority Decision Authorised
N.Date of Competent Authority Decision2022-07-06
N.Ethics Committee Opinion of the trial applicationFavourable
N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
N.Date of Ethics Committee Opinion2021-09-03
P. End of Trial
P.End of Trial StatusTrial now transitioned

Patrocinadores y Colaboradores

Condiciones médicas

Intervenciones de drogas

3
Suscribir