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    Summary
    EudraCT Number:2018-001456-34
    Sponsor's Protocol Code Number:CTMX-M-2029-001
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2019-06-25
    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 ConcernedUK - MHRA
    A.2EudraCT number2018-001456-34
    A.3Full title of the trial
    A Phase 1-2, First-in-Human Study of CX-2029 in Adults with
    Metastatic or Locally Advanced Unresectable Solid Tumors or
    Diffuse Large B-cell Lymphomas
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A phase 1-2, first-in-human study of CX-2029 in adults with advanced solid tumors which cannot be removed completely through surgery, or cancer of B cells, a type of white blood cell responsible for producing antibodies.
    A.3.2Name or abbreviated title of the trial where available
    PROCLAIM-CX-2029
    A.4.1Sponsor's protocol code numberCTMX-M-2029-001
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03543813
    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 SponsorCytomX Therapeutics, Inc.
    B.1.3.4CountryUnited States
    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 supportCytomX Therapeutics, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCytomX Therapeutics, Inc.
    B.5.2Functional name of contact pointClinical Trial Information Desk
    B.5.3 Address:
    B.5.3.1Street Address151 Oyster Point Boulevard, Suite 400
    B.5.3.2Town/ citySouth San Francisco
    B.5.3.3Post codeCA 94080-1913
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1650515 3185
    B.5.5Fax number+1650351 0353
    B.5.6E-mailclinicaltrials@cytomx.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 nameCX-2029
    D.3.2Product code CX-2029
    D.3.4Pharmaceutical form Powder 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 INNNot established
    D.3.9.2Current sponsor codeCX-2029
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    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 Yes
    D.3.11.13.1Other medicinal product typeProbody Drug Conjugate
    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
    Metastatic or locally advanced unresectable solid tumor or diffuse large B-cell lymphoma
    E.1.1.1Medical condition in easily understood language
    Cancer
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level HLT
    E.1.2Classification code 10012819
    E.1.2Term Diffuse large B-cell lymphomas
    E.1.2System Organ Class 100000004851
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10061873
    E.1.2Term Non-small cell lung cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10067821
    E.1.2Term Head and neck cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10065147
    E.1.2Term Malignant solid tumor
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level PT
    E.1.2Classification code 10030137
    E.1.2Term Oesophageal adenocarcinoma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level PT
    E.1.2Classification code 10061534
    E.1.2Term Oesophageal squamous cell carcinoma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10066354
    E.1.2Term Adenocarcinoma of the gastroesophageal junction
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level PT
    E.1.2Classification code 10041826
    E.1.2Term Squamous cell carcinoma of lung
    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 A
    The primary objective of Part A is to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of CX-2029, by evaluating the overall safety profile and dose-limiting toxicities (DLTs).

    Part B
    The primary objectives of Part B are to:
    • Characterize the protease activity and measure the cleavage of CX-2029 in tumour biopsies and peripheral blood in subjects with histologically or cytologically confirmed metastatic or locally advanced HNSCC, DLBCL, NSCLC (squamous cell histology only), or oesophageal (EAC, ESCC, or GE function) cancer
    • Obtain additional characterization of the safety of CX-2029

    Part C
    The primary objective of Part C is to evaluate the antitumour activity of CX-2029 in subjects with histologically or cytologically confirmed metastatic or locally advanced HNSCC, DLBCL, NSCLC (squamous cell
    histology only), or esophageal (EAC, ESCC, or GE junction) cancer in
    expanded cohorts using the MTD/RP2D determined in Part A.
    E.2.2Secondary objectives of the trial
    Part A:
    • Evaluate antitumor activity based on:
    - Objective response rate (ORR) by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or tumor-specific criteria, as applicable
    - Duration of response (DOR)

    • Characterize the pharmacokinetics (PK) of CX-2029 (total and intact) and MMAE (conjugated and unconjugated)
    • Assess the incidence of antidrug antibody (ADA) formation to CX-2029


    Part B:
    • Evaluate the ORR by RECIST v1.1 for solid tumors or the modified Lugano Classification for Lymphomas for DLBCL
    • Characterize the PK of CX-2029 (total and intact) and MMAE (conjugated and unconjugated)
    • Assess the incidence of ADA formation to CX-2029


    Part C:
    • Obtain additional characterization of the safety of CX-2029
    • Evaluate antitumor activity based on:
    - TTR
    - DOR
    - PFS
    - OS
    • Characterize the PK of CX-2029 (total and intact) and MMAE (conjugated and unconjugated)
    • Assess the incidence of ADA formation to CX-2029
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion Criteria for All Study Parts (Parts A, B, and C):
    1. At least 18 years old
    2. Ability to understand and willingness to sign a written informed consent form (ICF)
    3. Screening laboratory values must meet the following criteria:
    - Absolute neutrophil count ≥1500/μL
    - Platelet count ≥100 × 10^3/μL (no transfusion within 2 weeks)
    - Haemoglobin ≥10.0 g/dL (no transfusion within 2 weeks)
    - Creatinine ≤1.5 × institution’s upper limit of normal (ULN)
    - Both aspartate aminotransferase (AST) and alanine aminotransferase
    (ALT) ≤2.5 x institution's ULN; for subjects with liver metastases, AST
    and ALT ≤5 x institution's ULN
    - Total bilirubin ≤1.5 × ULN (total bilirubin must be ≤3 × institution’s ULN in subjects with Gilbert’s syndrome)
    4. Subjects with treated brain metastases (surgery, stereotactic
    radiation, whole brain radiation or a combination of these modalities)
    are eligible if the subject's brain metastases have been documented to
    be are stable by head imaging (two scans at least 28 days apart, including the scan obtained during the screening period) and the screening clinical examination is stable and the subject does not require radiation therapy or high-dose steroids (prednisone of 10 mg/day or equivalent). Active screening for brain metastases (e.g., brain computed tomography or magnetic resonance imaging) is not required
    5. Subjects with NSCLC (Part A: any histology; Parts B and C: squamous
    histology): o Must have received prior treatment with platinum-based therapy
    (unless intolerant or not suitable) and a PD-1/PD-L1 inhibitor. A
    checkpoint inhibitor should have been administered if approved for the
    subject's indication in their locality, alone or in combination with other
    therapy
    o Subjects with non-squamous cell histology must have undergone
    specific genomic testing performed (epidermal growth factor receptor
    [EGFR], anaplastic lymphoma kinase [ALK], ROS1, B-RAF)
    o Subjects with squamous cell histology are not required to have specific
    genomic testing performed (such as EGFR, ALK, ROS1, B-RAF, Kirsten rat
    sarcoma [KRAS], MET, RET, and neurotrophic-tropomyosin receptor
    kinase [NTRK]); testing may be performed but is not required. If a
    subject is known to carry a genetic mutation or translocation, the
    subject should have received the appropriate targeted therapy and
    progressed or shown intolerance to the therapy prior to enrollment in this protocol
    o Subjects with advanced or metastatic stage IV NSCLC with known
    EGFR or ALK genomic alterations are eligible if they have progressed on
    treatment or did not tolerate appropriate targeted therapy. This would
    include osimertinib for T790M mutation-positive NSCLC.
    o Subjects with known NSCLC with known ROS1 rearrangement must
    have received prior treatment with crizotinib
    o Subjects with known B-RAF mutations must have received prior
    treatment with a B RAF inhibitor
    6. Females of childbearing potential and non-sterile males must agree to
    practice highly effective methods of birth control (as described in
    Appendix E) for the duration of the study and for 6 months after the last
    dose of study drug. In addition, non-sterile males must agree to use a
    highly effective method of contraception prior to study entry, while on
    study drug, and for a period of 50 days after the last dose of CX-2029
    and to avoid sperm donation for the duration of the study and for 6
    months after the last dose of study drug.
    Inclusion Criteria Specific for Part A, Part B, or Part C
    Part A:
    1. Histologically or cytologically confirmed metastatic or locally advanced unresectable solid tumor
    2. Documented progression or relapse after at least 1 prior systemic therapy, unless systemic therapy is not available or is not suitable. Moreover, subjects must have exhausted available life prolonging therapies
    3. Measurable or evaluable per RECIST v1.1
    4. Eastern Cooperative Oncology Group (ECOG) 0 to 1
    5. Agreement to provide tumour tissue; archival, new, or recent
    acquisition confirmed to be available prior to initiation of study drug for
    performance of correlative tissue and cellular studies from a tumor site
    not previously irradiated; biopsy should not be performed for the
    purpose of determining eligibility for this study. Biopsy should only be
    undertaken during the screening period if considered to be safe by the Investigator and with consent from the subject.
    Part B
    1. Histologically or cytologically confirmed metastatic or locally
    advanced unresectable HNSCC, DLBCL, NSCLC (squamous cell histology
    only), or esophageal (EAC, ESCC, or GE junction) cancer
    2. Subjects with HNSCC must have received a platinum-containing regimen (unless intolerant or not suitable) and a PD-1 inhibitor if approved for the subject’s indication in the subject’s locality

    Refer to study protocol for additional Part B inclusion criteria.

    Refer to study protocol for Part C inclusion criteria.
    E.4Principal exclusion criteria
    1. Neuropathy >Grade 1
    2. Serious concurrent illness, including, but not limited to, the following:
    - Clinically-relevant infection, including known active hepatitis B or C, human immunodeficiency virus, or non-viral infection requiring antibiotics
    - Significant cardiac disease, such as recent myocardial infarction (≤6 months prior to Cycle 1 Day 1), unstable angina pectoris, uncontrolled congestive heart failure (New York Heart Association >Class II), uncontrolled diabetes (hemoglobin A1c [HbA1c] >7%) uncontrolled hypertension (NCI CTCAE Version 5.0 Grade 3 or higher), uncontrolled cardiac arrhythmias, severe aortic stenosis, or ≥Grade 3 cardiac toxicity following prior chemotherapy
    - History of hemorrhagic or ischemic stroke within the last 6 months, or clinically significant alcoholic liver disease
    - History of or current active autoimmune diseases, including but not
    limited to inflammatory bowel diseases, rheumatoid arthritis,
    autoimmune thyroiditis which is not a sequela of prior immune
    checkpoint therapy, autoimmune hepatitis, systemic sclerosis, systemic
    lupus erythematosus, autoimmune vasculitis, autoimmune neuropathies,
    or type 1 insulin dependent diabetes mellitus
    - History of or current active autoimmune diseases, including but not
    limited to inflammatory bowel diseases, rheumatoid arthritis,
    autoimmune thyroiditis which is not a sequela of prior immune
    checkpoint therapy, autoimmune hepatitis, systemic sclerosis, systemic
    lupus erythematosus, autoimmune vasculitis, autoimmune neuropathies,
    or type 1 insulin dependent diabetes mellitus
    - History of or current active autoimmune diseases, including but not limited to inflammatory bowel diseases, rheumatoid arthritis, autoimmune thyroiditis which is not a sequela of prior immune checkpoint therapy, autoimmune hepatitis, systemic sclerosis, systemic lupus erythematosus, autoimmune vasculitis, autoimmune neuropathies, or type 1 insulin dependent diabetes mellitus
    - Non-healing wound(s) or ulcer(s) except for ulcerative lesions caused by the underlying neoplasm
    - Psychiatric illness/social situations that would limit compliance with study requirements
    - Interstitial lung disease irrespective of etiology
    - Hepatic impairment which is moderate (Child-Pugh B) or severe (Child-Pugh C)
    - Severe renal impairment (creatinine clearance [CrCl] <30 mL/min)
    3. Any prohibited medications as described in the protocol including but
    not limited to: Chemotherapy, non-biological anticancer therapies and
    radiotherapy within 14 days prior to Cycle 1 Day 1; biologics
    (monoclonal antibodies) require a 30 -day interval prior to receiving the
    first dose of study drug
    4. History of severe allergy or anaphylactic reaction to previous monoclonal antibodies or known hypersensitivity to auristatins
    5. Unresolved acute toxicity NCI CTCAE Version 5.0 >Grade 1 (or baseline, whichever is greater) from prior anticancer therapy. Alopecia and other non-acute toxicities are acceptable
    6. History of malignancy within the previous 2 years except for localized basal cell or squamous cell skin cancers, superficial bladder cancers, or carcinoma in situ of the prostate, cervix, or breast
    7. Concurrent anticoagulation with warfarin
    8. Inability to discontinue treatment with a strong CYP3A4 inhibitor or strong CYP3A4 inducer prior to start of treatment
    9. Clinically significant iron metabolism disorders (eg, sickle cell anemia)
    10. Transfusion dependent anaemia with transfusion of at least one unit
    of packed red blood cells required every 90 days to maintain haemoglobin
    >10 g/dL over the past 12 months
    11. Use of iron chelators (such as desferrioxamine, deferiprone, and
    deferasirox)
    11. Use of iron chelators
    12. Major surgery within 3 months prior to study enrollment
    13. Live vaccine within 28 days prior to planned dose
    14. Participation in an ongoing clinical study involving medications, radiation, or surgery
    15. Women who are pregnant or breast-feeding
    E.5 End points
    E.5.1Primary end point(s)
    Dose-limiting toxicities
    Study-drug related AEs and AEs leading to discontinuation
    Changes from baseline in clinical laboratory results and vital signs
    E.5.1.1Timepoint(s) of evaluation of this end point
    Administrative interim analyses on safety and efficacy or on PK, immunogenicity, and selected biomarkers may be performed at several times prior to completion of the study in order to facilitate program decisions and to support study presentations or publications
    E.5.2Secondary end point(s)
    Objective Response Rate (ORR) is the primary efficacy endpoint.
    Duration of response (DOR).
    Time To Tumor Response (TTR).
    Progression-free survival (PFS).
    Overall survival (OS).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Administrative interim analyses on safety and efficacy or on PK,
    immunogenicity, and selected biomarkers may be performed at several times prior to completion of the study in order to facilitate program decisions and to support study presentations or publications
    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 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 Yes
    E.6.13.1Other scope of the trial description
    Immunogenicity
    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 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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA9
    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
    Spain
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee Yes
    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 days
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months6
    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: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 state11
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 28
    F.4.2.2In the whole clinical trial 150
    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)
    After study completion, subjects who continue to receive clinical benefit (as judged by the Investigator) may rollover to a companion protocol, if available.
    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 Decision2018-12-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-03-29
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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