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    Summary
    EudraCT Number:2021-001789-39
    Sponsor's Protocol Code Number:LAVA1207-001
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2021-06-15
    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
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedNetherlands - Competent Authority
    A.2EudraCT number2021-001789-39
    A.3Full title of the trial
    A Phase 1 and 2a open-label trial to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and antitumor activity of LAVA-1207, a PSMA-targeting bispecific γδ-T cell engager, alone or with low dose interleukin-2 or Pembrolizumab, in patients with therapy refractory metastatic castration resistant prostate cancer
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    LAVA-1207 Open Label study in patients with therapy refractory metastatic castration resistant prostate cancer
    A.4.1Sponsor's protocol code numberLAVA1207-001
    A.5.4Other Identifiers
    Name:IND NumberNumber:154214
    Name:Merck NumberNumber:KEYNOTE F73
    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 SponsorLAVA Therapeutics N.V.
    B.1.3.4CountryNetherlands
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportLAVA Therapeutics N.V.
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLAVA Therapeutics N.V.
    B.5.2Functional name of contact pointClinical Operations
    B.5.3 Address:
    B.5.3.1Street Address520 Walnut Street, Suite 1150
    B.5.3.2Town/ cityPhiladelphia
    B.5.3.3Post codePA 1910
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1 8003116892
    B.5.6E-mailclinicaltrials@lavatherapeutics.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 nameLAVA-1207
    D.3.2Product code NA
    D.3.4Pharmaceutical form 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.3.9.3Other descriptive nameHumanised bispecific immunoglobulin VHH fragments against PSMA and Vgamma9Vdelta2 T-cell receptor
    D.3.9.4EV Substance CodeSUB224040
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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 No
    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 Yes
    D.2.1.1.1Trade name Pembrolizumab
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Sharp & Dohme B.V.
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 nameKEYTRUDA 25 mg/mL
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInfusion (Noncurrent)
    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 No
    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
    Prostate Cancer
    E.1.1.1Medical condition in easily understood language
    Prostate Cancer
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 27.0
    E.1.2Level PT
    E.1.2Classification code 10036909
    E.1.2Term Prostate cancer metastatic
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Part 1
    Dose Escalation for LAVA-1207 alone, LAVA-1207 plus LDSC IL-2, and LAVA-1207 plus pembrolizumab.
    To investigate the safety and tolerability of treatment in patients with therapy refractory mCRPC.
    To determine the preliminary RP2D in patients with therapy refractory mCRPC for LAVA-1207 monotherapy, for LAVA-1207 + LDSC IL-2, and for
    LAVA-1207 + pembrolizumab.

    Part 2

    To investigate the safety and tolerability at the RP2D in therapy refractory mCRPC patients with measurable and non-measurable
    refractory mCRPC patients with measurable and non-measurable disease.
    E.2.2Secondary objectives of the trial
    Part 1 Dose Escalation and Part 2 Expansion Cohort for LAVA-1207 alone, LAVA-1207 plus LDSC IL-2, and LAVA-1207 plus pembrolizumab
    • To explore the preliminary antitumor activity
    • To evaluate the pharmacokinetics of LAVA-1207.
    • To evaluate the pharmacodynamics of LAVA-1207.
    • To evaluate the immunogenicity of LAVA-1207.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion criteria (for patients treated with LAVA-1207 +/- LDSC IL-2):
    1. Patient must be 18 years of age inclusive or above, at the time of signing the informed consent.
    2. Male patient with mCRPC as defined by PCWG3 criteria (histologically confirmed adenocarcinoma; adenocarcinoma with ≤10% small-cell or neuroendocrine features is allowed). Brain metastasis are allowed as long as the patient’s symptoms are well controlled.
    3. Patient should have failed at least 1 line of taxane-based chemotherapy or is deemed medically unsuitable to be treated with a taxane regimen.
    4. Patient should have received a 2nd generation or later androgen receptor targeted therapy/ androgen biosynthesis inhibitor (e.g. abiraterone, enzalutamide, and/or apalutamide). Progression on novel antiandrogen therapy may have occurred in the non-metastatic CRPC setting.
    5. Patients will be unlikely to tolerate or derive clinically meaningful benefit from other available therapy.
    6. Patients for which any drug related toxicity adverse effects of any prior cancer therapy should have resolved to Grade 1 or less according CTCAE v5.0 or to baseline severity level (except for alopecia or peripheral neuropathy).
    7. Patients has evidence of progressive disease, defined as 1 or more of the following criteria:
    a. PSA level ≥1 ng/mL that has increased on at least 2 successive occasions at least 1 week apart.
    b. Computed tomography (CT) or magnetic resonance imaging (MRI) scan: nodal or visceral
    progression as defined by RECIST 1.1.
    c. Bone scintigraphy: appearance of 2 or more new metastatic lesions.
    8. Patient should have undergone bilateral orchiectomy or should be on continuous androgendeprivation therapy (ADT) with a gonadotropin-releasing hormone agonist or antagonist (surgical or medical castration).
    9. Total serum testosterone ≤ 50 ng/dL or 1.73 nmol/L.
    10. Evaluable (measurable or non-measurable) disease for prostate cancer.
    11. Predicted life-expectancy of ≥ 6 months.

    Inclusion criteria for LAVA-1207 plus pembrolizumab arm:
    1. Patient must be 18 years of age inclusive or above, at the time of signing the informed consent.
    2. Male patient with mCRPC as defined by PCWG3 criteria (histologically confirmed adenocarcinoma; adenocarcinoma with ≤10% small-cell or
    neuroendocrine features is allowed).
    Brain metastases are allowed as long as the patient's symptoms are well controlled, i.e., without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study treatment.
    3. Patient should have failed at least 1 line of taxane-based chemotherapy or is deemed medically unsuitable to be treated with a taxane regimen.
    4. Patient should have received a 2nd generation or later androgen receptor targeted therapy/androgen biosynthesis inhibitor (e.g. abiraterone, enzalutamide, and/or apalutamide). Progression on novel anti-androgen therapy may have occurred in the non-mCRPC setting.
    5. Patient is unlikely to tolerate or derive clinically meaningful benefit from other available therapy.
    6. Patient for which any drug-related toxicity adverse effects of any prior cancer therapy should have resolved to Grade 1 or less according CTCAE version 5.0 or to baseline severity level (except alopecia or peripheral neuropathy).
    7. Patient has evidence of progressive disease, defined as 1 or more of the following criteria:
    a. PSA level ≥1 ng/mL that has increased on at least 2 successive occasions at least 1 week apart.
    b. CT or MRI scan: nodal or visceral progression as defined by RECIST 1.
    8. Patient should have undergone bilateral orchiectomy or should be on continuous ADT with a gonadotropin-releasing hormone agonist or antagonist (surgical or medical castration).
    9. Total serum testosterone ≤ 50 ng/dL or 1.73 nmol/L.
    10. Evaluable (measurable or non-measurable) disease for prostate cancer.
    11. Predicted life-expectancy of ≥ 6 months.
    E.4Principal exclusion criteria
    Exclusion Criteria (for patients treated with LAVA-1207 +/- LDSC IL-2):
    1. Other malignancies within the last 2 years except adequately treated carcinoma in situ, basal or squamous cell skin carcinoma.
    2. Uncontrolled or severe intercurrent medical condition.
    3. Positive serological testing for human immunodeficiency virus (HIV) antibody.
    4. Positive serological hepatitis B surface antigen [HbsAg] and hepatitis B core antibody (anti-HBc) negative, and hepatitis C virus antibody. Patients who are positive for anti-HBc or hepatitis C antibody may be included if they have a negative polymerase chain reaction (PCR) within 6 weeks prior to initial IMP administration. Those who are PCR positive will be excluded.
    5. Patient has any active, uncontrolled, or suspected infection.
    6. Known clinically relevant immunodeficiency disorders.
    7. A significant history of renal, neurologic, psychiatric, pulmonary, endocrinologic, metabolic, immunologic, cardiovascular, or hepatic disease that in the opinion of the investigator would adversely affect participation in this trial.
    8. Unstable cardiovascular function defined as: (a) symptomatic ischemia, or (b) uncontrolled clinically significant conduction abnormalities (i.e. ventricular
    tachycardia on antiarrhythmic agents are excluded; 1st degree atrioventricular block or asymptomatic left anterior fascicular block/right bundle branch block is not excluded), or (c) congestive heart failure New York Heart Association Class ≥ 3, or (d) myocardial infarction within 3 months.
    9. Previous treatment with antitumor therapies within 2 weeks prior to initial IMP for radiotherapy and androgen receptor targeted therapy/androgen biosynthesis inhibitor, and within 4 weeks for systemic chemotherapy or targeted immunotherapy.
    10. Previous treatment with live or live attenuated vaccines within 2 weeks prior to initial IMP administration. New types of vaccines need to be evaluated as to their mode of action.
    11. Treatment with other investigational agents in the 4 weeks prior to initial IMP administration.
    12. Major surgery within 4 weeks prior to initial IMP administration.
    13. Hypersensitivity to any of the excipients present in LAVA-1207 or IL-2 (if applicable).

    Exclusion Criteria for LAVA-1207 plus pembrolizumab arm:
    1. Other malignancies within the last 2 years except adequately treated carcinoma in situ, basal or squamous cell skin carcinoma.
    2. Seropositive for and with evidence of active viral infection with hepatitis B virus (HBV). Patients who are HbsAg negative and HBV viral DNA negative are eligible. Patients who had HBV but have received an antiviral treatment and show non-detectable viral DNA for 6 months are eligible.
    Patients who are seropositive because of HBV vaccine are eligible.
    3. Seropositive for and with active viral infection with hepatitis C virus (HCV). Patients who had HCV but have received an antiviral treatment and show no detectable HCV viral DNA for 6 months are eligible.
    4. History of allogenic tissue or solid organ transplant.
    5. Positive serological testing for HIV.
    6. Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients.
    7. Hypersensitivity to any of the excipients present in LAVA-1207.
    8. Active infection requiring systemic therapy.
    9. Has a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
    10. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.
    11. Has an active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary
    insufficiency) is not considered a form of systemic treatment and is allowed.
    12. Has received prior therapy with an anti-programmed cell death 1 (PD 1), anti-programmed cell death ligand 1 (PD-L1), or anti-programmed cell death ligand 2 (PD-L2) agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX 40, CD137), and was discontinued from that treatment due to a Grade 3 or higher immune related AE.
    13. A significant history of renal, neurologic, psychiatric, pulmonary, endocrinologic, metabolic, immunologic, cardiovascular, or hepatic disease that in the opinion of the investigator would adversely affect participation in this trial.
    E.5 End points
    E.5.1Primary end point(s)
    Part 1 Dose Escalation for LAVA-1207 alone, LAVA-1207 plus LDSC IL-2, and LAVA-1207 plus pembrolizumab
    Frequency and severity of AEs using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 and ASTCT grading for CRS.
    Frequency and type of DLT.

    Part 2 Expansion Cohort for LAVA-1207 alone and/or LAVA-1207 plus LDSC IL-2, and/or LAVA-1207 plus pembrolizumab
    Frequency and severity of AEs using the CTCAE version 5.0 and ASTCT grading of CRS at the RP2D.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Both for Part 1 and Part 2: Planned treatment duration is 24 weeks; this generally is sufficient to collect information to enable the assessment of the primary and secondary endpoints for both trial parts.
    E.5.2Secondary end point(s)
    Part 1 Dose Escalation and Part 2 Expansion Cohort (for LAVA-1207 alone and/or LAVA-1207 plus LDSC IL-2 and/or LAVA-1207 plus pembrolizumab)
    Number of participants with an antitumor response according to immune response evaluation criteria in solid tumors (RECIST and iRECIST) in patients with measurable disease. Duration of response. Disease control rate (DCR) for patients with measurable disease at 8, 16 and 24 weeks.
    Number of participants who experience any PSA decrease, and number of participants who experience a PSA decrease of ≥ 50% from baseline.
    Progression free survival (using Prostate Cancer Working Group 3 [PCWG3] for bone lesions and/or iRECIST criteria for soft-tissue lesions).
    Pharmacokinetic parameters.
    Pharmacodynamic markers.
    Incidence and prevalence of anti-LAVA-1207 antibodies
    E.5.2.1Timepoint(s) of evaluation of this end point
    Both for Part 1 and Part 2: Planned treatment duration is 24 weeks; this generally is sufficient to collect information to enable the assessment of the primary and secondary endpoints for both trial parts.
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy No
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    immunogenicity, Tolerability and antitumor activity of LAVA-1207.
    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 Yes
    E.7.1.3.1Other trial type description
    A Phase 1 and 2a open-label trial
    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.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA7
    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
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months6
    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: 27
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 55
    F.2 Gender
    F.2.1Female No
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state42
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 50
    F.4.2.2In the whole clinical trial 82
    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)
    At the request of the treating physician and in consultation with the sponsor, continued access to IMP may be offered beyond the planned treatment duration of 24 weeks for individual patients with ongoing disease control.
    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 Decision2021-06-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-07-13
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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