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    The EU Clinical Trials Register currently displays   43719   clinical trials with a EudraCT protocol, of which   7255   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    EudraCT Number:2021-000036-57
    Sponsor's Protocol Code Number:D9570C00001
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-04-29
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedNetherlands - Competent Authority
    A.2EudraCT number2021-000036-57
    A.3Full title of the trial
    A Phase I/IIa Open-label Dose Escalation and Expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of AZD7789, an anti-PD-1 and anti-TIM-3 Bispecific Antibody, in Participants with Advanced or Metastatic Solid Tumors
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to assess the safety and efficacy of AZD7789 in participants with advanced or metastatic solid cancer
    A.4.1Sponsor's protocol code numberD9570C00001
    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.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.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 Centre
    B.5.3 Address:
    B.5.3.1Street AddressNot applicable
    B.5.3.2Town/ cityNot applicable
    B.5.3.3Post codeNot applicable
    B.5.3.4CountryUnited States
    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 nameAZD7789
    D.3.2Product code AZD7789
    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 INNN/A
    D.3.9.2Current sponsor codeAZD7789
    D.3.9.3Other descriptive nameAZD7789
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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 Yes
    D. medicinal product typeBispecific antibody
    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 or Metastatic Non-small Cell Lung Carcinoma
    Solid Tumors
    E.1.1.1Medical condition in easily understood language
    Lung Cancer
    Solid Tumors
    Non-Small Cell Lung Carcinoma (NSCLC)
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    For Part A Dose Escalation:
    To assess the safety and tolerability, characterize the Dose Limiting Toxicities (DLTs), and determine the Maximum Tolerated Dose (MTD) or Optimal Biological Dose (OBD) and a Recommended Phase 2 Dose (RP2D) of AZD7789 in participants with advanced or metastatic solid tumors

    For Part B Dose Expansion:
    To assess the safety, tolerability and preliminary antitumor activity of AZD7789 in participants with advanced or metastatic solid tumors
    E.2.2Secondary objectives of the trial
    For Part A Dose Escalation:
    To assess the preliminary antitumor activity of AZD7789 in participants with advanced or metastatic solid tumours

    For Part B Dose Expansion:
    To further assess the preliminary antitumor activity of AZD7789 in participants with advanced or metastatic solid tumours

    For both Part A Dose Escalation and Part B Dose Expansion:
    To assess the PK and immunogenicity of AZD7789 in participants with advanced or metastatic solid tumours
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    General Inclusion Criteria for all cohorts:
    o Must be ≥ 18 years of age
    o Histologically or cytologically documented Stage IIIB to IV non-small cell lung carcinoma (NSCLC) not amenable to curative surgery or radiation
    o Must have at least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
    o Provision of archival or fresh tumor tissue sample and/or consent to undergo mandatory on-treatment biopsy for participants enrolled in Part A Dose-escalation
    o Provision of archival tumor tissue sample or fresh tissue sample for Part B Dose-expansion participants
    o Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
    o Non-pregnant women and willingness of female participants to avoid pregnancy or male participants willing to avoid fathering children through highly effective methods of contraception
    o Adequate organ and bone marrow function measured within 28 days prior to first dose

    o Part A Dose Escalation Additional Inclusion Criteria:
    • May have squamous or non-squamous NSCLC
    • Must have received at least one prior line of systemic therapy, of which at least one prior line of therapy contained approved anti-PD-1/PD-L1
    • Must have had immune-oncology (IO) acquired or primary resistance
    • PD-L1 expression < 1% or ≥ 1% documented

    o Part B Dose Expansion Cohort B1 Additional Inclusion Criteria:
    • May have squamous or non-squamous NSCLC
    • Must have received at least one prior line of systemic therapy, of which only one prior line of therapy contained approved anti-PD-1/PD-L1
    • Must have had IO acquired resistance
    • PD- L1 expression ≥ 1% documented

    o Part B Dose Expansion Cohort B2 Additional Inclusion Criteria:
    • May have squamous or non-squamous NSCLC
    • Must not have received prior systemic therapy including IO therapy in the first-line setting
    • PD-L1 expression ≥ 50% documented
    E.4Principal exclusion criteria
    o Patients with sensitizing epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) fusions
    o Documented test result for any other known genomic alteration for which a targeted first line therapy is approved per local standard of care (SoC)
    o Unresolved toxicities of ≥ Grade 2 from prior therapy
    o Any prior ≥ Grade 3 immune-mediated adverse event (imAE) while receiving immunotherapy or any unresolved imAE ≥ Grade 2
    o Must not have experienced a toxicity that led to permanent discontinuation of prior immunotherapy
    o Symptomatic central nervous system (CNS) metastasis or leptomeningeal disease
    o History of symptomatic and objectively confirmed arterial (including myocardial infarction) or venous thromboembolic event within 6 months prior to the first dose of study intervention
    o History of organ transplant or allogenic haematopoietic stem cell transplant
    o Infectious disease exclusions: Active infection including TB, HIV, hepatitis A, chronic or active hepatitis B, chronic or active hepatitis C, active COVID-19 infection
    o History of arrhythmia which is symptomatic or requires treatment; symptomatic or uncontrolled atrial fibrillation despite treatment, or asymptomatic sustained ventricular tachycardia
    o Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, cardiomyopathy of any etiology, symptomatic congestive heart failure, uncontrolled hypertension, uncontrolled diabetes mellitus, unstable angina pectoris, history of myocardial infarction within the past 6 months, serious chronic gastrointestinal conditions associated with diarrhea, active non infectious skin disease
    o Active or prior documented autoimmune or inflammatory disorders, including inflammatory bowel disease (eg, colitis or Crohn's disease), diverticulitis (with the exception of diverticulosis), systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome (granulomatosis with polyangiitis), Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc.. Some exceptions have been specified in the protocol
    o Past medical history of interstitial lung disease (ILD), drug-induced ILD, radiation pneumonitis requiring steroid treatment, or any evidence of clinically active ILD
    o Major surgical procedure within 28 days prior to the first dose of study intervention or still recovering from prior surgery
    o Other invasive malignancy within 2 years prior to screening
    o Congenital long QT syndrome or history of QT prolongation associated with other medications that cannot be changed or discontinued based on a cardiologist assessment
    o Previous treatment with anti-TIM-3 therapy in any setting
    o Current or prior use of immunosuppressive medication within 14 days prior to the first dose of study intervention
    o Any concurrent chemotherapy, radiotherapy, investigational, biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for noncancer-related conditions is acceptable.
    o Receipt of live attenuated vaccine within 30 days prior to the first dose of study intervention Note: Participants should not receive live vaccine while receiving study intervention and up to 30 days after the last dose of study intervention
    o Radiotherapy treatment to the lung within ≤ 4 weeks of the first dose of AZD7789. Palliative bone radiotherapy is allowed if ≥ 2 weeks prior to the first dose of AZD7789.
    E.5 End points
    E.5.1Primary end point(s)
    o Adverse Events (AEs), imAEs, Serious Adverse Events (SAEs), and DLTs
    o AEs leading to discontinuation of AZD7789
    o Clinically significant alterations in vital signs, laboratory parameters, and ECG results
    o Part B Dose Expansion: Objective Response Rate (ORR) according to RECIST v1.1
    E.5.1.1Timepoint(s) of evaluation of this end point
    From time of informed consent to study completion as defined in the protocol
    E.5.2Secondary end point(s)
    For Dose Escalation:
    o ORR, Disease Control Rate (DCR), Duration of Response (DoR), and Progression-free Survival (PFS) according to RECIST v1.1, changes in ctDNA and Overall Survival (OS)

    For Dose Expansion:
    o DCR, DoR, PFS according to RECIST v1.1, changes in ctDNA and OS

    For Dose Escalation and Expansion:
    o PK parameters including Cmax, AUC, clearance, and t 1/2
    o Incidence of ADAs against AZD7789 in serum
    E.5.2.1Timepoint(s) of evaluation of this end point
    From time of informed consent to study completion as defined in the protocol
    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 Yes
    E.6.11Pharmacogenomic Yes
    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. 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 No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    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 EEA3
    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
    United States
    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
    End of the trial is defined as the date of the last visit of the last participant in the study or last scheduled procedure shown in the schedule of assessments 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 years4
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    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: 41
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 40
    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 state5
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 35
    F.4.2.2In the whole clinical trial 81
    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)
    Provisions will be in place for participants still enrolled at the end of the trial to continue to receive study intervention if, in the opinion of the Investigator, they are continuing to receive benefit from treatment.
    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 Decision2021-04-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-05-12
    P. End of Trial
    P.End of Trial StatusOngoing
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