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    Summary
    EudraCT Number:2020-004952-14
    Sponsor's Protocol Code Number:0209-01
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2021-01-15
    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 ConcernedFrance - ANSM
    A.2EudraCT number2020-004952-14
    A.3Full title of the trial
    A Phase 1/2 Study of CPI-0209 Monotherapy and in Combination with Other Therapy in Patients with Advanced Tumors
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study of CPI-0209 in Patients With Advanced Tumors
    A.3.2Name or abbreviated title of the trial where available
    CPI-0209 in Patients with Advanced Tumors
    A.4.1Sponsor's protocol code number0209-01
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04104776
    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 SponsorConstellation Pharmaceuticals, 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 supportConstellation Pharmaceuticals, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationConstellation Pharmaceuticals, Inc.
    B.5.2Functional name of contact pointSamuel Bonilla
    B.5.3 Address:
    B.5.3.1Street Address215 First Street, Suite 200
    B.5.3.2Town/ cityCambridge
    B.5.3.3Post codeMA 02142
    B.5.3.4CountryUnited States
    B.5.4Telephone number+16178446884
    B.5.5Fax number+16175770342
    B.5.6E-mailSamuel.Bonilla@constellationpharma.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 nameCPI-0209
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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) No
    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
    advanced, solid, relapsed tumors / advanced tumors: human lymphomas / solid human tumor indications (urothelial carcinoma, ovarian clear cell cancer, endometrial carcinoma, GCB-DLBCL, small cell lung cancer, gastric or GEJ adenocarcinoma, serous ovarian cancer,)
    E.1.1.1Medical condition in easily understood language
    advanced, solid, relapsed tumors / advanced tumors
    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
    Phase 1:
    Determine maximum tolerated dose (MTD) and/or RP2D of CPI-0209 as monotherapy and in combination with irinotecan in patients with advanced tumors

    Phase 2:
    Evaluate the antitumor activity of CPI-0209 as monotherapy and in combination with irinotecan in patients with selected tumors
    E.2.2Secondary objectives of the trial
    Phase 1:
    - Characterize the safety and tolerability of CPI-0209 as monotherapy and in combination with irinotecan
    - Characterize the pharmacokinetic (PK) and pharmacodynamic (PD) profile of CPI-0209 as monotherapy and in combination with irinotecan
    - Evaluate the preliminary clinical activity of CPI-0209 as monotherapy and in combination with irinotecan in patients with advanced tumors

    Phase 2:
    - Further characterize the safety and tolerability of CPI-0209 as monotherapy and in combination with irinotecan in patients with selected tumors
    - Further characterize the PK and PD profile of CPI-0209 as monotherapy and in combination with irinotecan
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Eligible Phase 1 monotherapy and combination patients are adults who have a confirmed locally advanced or metastatic tumors (solid tumors or lymphoma) that have relapsed following standard therapy or progressed through standard therapy or who have a disease for which no standard effective therapy exists.
    Eligible Phase 2 monotherapy patients in cohorts M1 to M3 are adults who are known to have the ARID1A mutation, have measurable disease per RECIST 1.1 and who have confirmed relapsed urothelial (M1), ovarian clear cell carcinoma (M2), or endometrial carcinoma (M3).
    Eligible Phase 2 monotherapy patients in cohort M4 are adults who have relapsed or refractory GCB-DLBCL with at least 2 prior lines of standard therapy who are not considered candidates to receive CAR-T or ASCT therapy.
    Eligible Phase 2 combination therapy patients in cohorts C1-C3 are adults who have measurable disease per RECIST 1.1 and who have confirmed small cell lung cancer (C1), gastric or GEJ adenocarcinoma (C2), or serous ovarian cancer (C3). All patients will have Eastern Cooperative Oncology Group (ECOG) performance status of ≥ 1, absolute neutrophil count (ANC) ≥ 1.5 × 109/L, platelet count of ≥ 100 × 109/L, and hemoglobin of ≥ 9.0 g/dL.
    All patients will have adequate renal function defined as creatinine clearance >40 mL/min or serum creatinine ≤ 1.5 × ULN, and adequate hepatic function defined as serum total bilirubin ≤ 1.5 × upper limit of normal (ULN), AST/ALT ≤ 2.5 × ULN (or ≤ 5 × ULN in patients with liver metastases); for patients in combination therapy (CPI-0209 + irinotecan) serum total bilirubin ≤ 1.5 ULN, or ≤ 2.0 mg/dL, whichever is lower.
    E.4Principal exclusion criteria
    1. Previous solid organ or hematopoietic cell transplant.
    2. Known symptomatic untreated brain metastases. Patients with CNS metastases must have stable neurologic status following local therapy for at least 4 weeks on stable or decreasing dose of steroid ≤ 10 mg daily prednisone (or equivalent). Patients in the M4 lymphoma cohort will not be eligible if they have CNS involvement by lymphoma.
    3. Clinically significant cardiovascular disease including:
    a. Myocardial infarction (MI)/stroke within 3 months prior to Day 1 of treatment
    b. Unstable angina within 3 months prior to Day 1 of treatment
    c. Congestive heart failure (CHF) or cardiomyopathy with New York Heart Association Class 3 or 4
    d. History of clinically significant ventricular arrhythmias (eg, ventricular tachycardia, ventricular fibrillation, torsades de pointes)
    e. Uncontrolled hypertension (as defined per institutional standards) despite 2 concomitant antihypertensive therapies
    f. QT interval corrected by the Fridericia correction formula ≥ 480 msec on the screening ECG
    4. Major surgery within 4 weeks before starting study drug or not recovered from any effects of prior major surgery (uncomplicated central line placement or fine needle aspirate are not considered major surgery)
    5. Gastrointestinal disorders ie, ulcerative colitis, malabsorption syndrome, refractory nausea and vomiting, biliary shunt, significant bowel resection, or any other condition that may significantly interfere with absorption of the study medication by Investigator’s assessment
    6. Uncontrolled active infection requiring IV antibiotic, antiviral, or antifungal medications within 14 days before the first dose of study drug. Infections (eg, urinary tract infection) controlled on concurrent antimicrobial agents and antimicrobial prophylaxis per institutional guidelines are acceptable.
    7. Suspected pneumonitis or interstitial lung disease (confirmed radiography or CT) or a history of pneumonitis or interstitial lung disease
    8. Have a history of a concurrent or second malignancy except for adequately treated local basal cell or squamous cell carcinoma of the skin, cervical carcinoma in situ, superficial bladder cancer, asymptomatic prostate cancer without known metastatic disease and with no requirement for therapy or requiring only hormonal therapy and with normal prostate-specific antigen for ≥ 1 year prior to randomization, adequately treated Stage 1 or 2 cancer currently in complete remission, or any other cancer that has been in complete remission for ≥ 3 years. Patients with a history of t-cell lymphoblastic lymphoma or T-Cell lymphoblastic leukemia are not eligible.
    9. Have current known active or chronic infection with HIV, hepatitis B, or hepatitis C
    10. Clinically active or symptomatic viral hepatitis or chronic liver disease
    11. Unstable or severe uncontrolled medical condition or any important medical or psychiatric illness or abnormal laboratory finding that would, in the Investigator’s judgment, increase the risk to the patient associated with his or her participation in the study
    12. Prior anticancer treatment as follows:
    a. Prior systemic anticancer treatment with chemotherapy, targeted therapy, small molecule, antibody, or investigational anticancer therapy (includes prior PD-1 or PD-L1 therapy), or other anticancer therapeutic within 4 weeks (or 5 half-lives), whichever is shorter, before the first dose of study drug (6 weeks washout for nitrosoureas or mitomycin C)
    b. Previous treatment with an EZH2 inhibitor
    c. Prior radiation therapy (including radiofrequency ablation) within 4 weeks before first dose of study drug
    d. Prior stereotactic body radiation therapy within 2 weeks before first dose of study drug
    e. Prior chemoembolization or radioembolization within 4 weeks before first dose of study drug
    13. Concomitant medication(s) or food or beverage that are moderate or strong CYP3A inducers or inhibitors within 2 weeks prior to the first dose of study drug
    14. Women who are lactating or pregnant. Female patients with β-hCG values that are within the range for pregnancy but are not pregnant (false-positives) may be enrolled with written consent of the Sponsor’s Medical Monitor, after pregnancy has been excluded.
    15. Are unwilling or unable to comply with this study protocol or study requirements.
    Additional Exclusion Criteria for Cohorts C1 to C3 only
    16. Known Gilbert’s disease or known homozygosity for UGT1A1*28 allele.
    17. Prior irinotecan or topotecan therapy
    E.5 End points
    E.5.1Primary end point(s)
    Phase 1:
    Dose limiting toxicities

    Phase 2:
    ORR, defined as proportion of patients with:
    - a best overall response of complete response (CR) or partial response (PR), per Investigator assessment based on RECIST 1.1 or applicable response criteria in patients with solid tumors
    - a best overall response per complete response or partial response, per Investigator assessment based on the 2014 Lugano criteria in patients with lymphoma
    E.5.1.1Timepoint(s) of evaluation of this end point
    End of study
    E.5.2Secondary end point(s)
    Phase 1:
    - Adverse events (AEs) and change in laboratory values
    - PK and PD parameters
    - Objective response rate (ORR), defined as proportion of patients with a best overall response of complete response (CR) or partial response (PR), per Investigator assessment based on RECIST 1.1 or applicable response criteria
    - ORR per Gynecologic Cancer Intergroup (GCIG)-defined CA-125 response criteria (ovarian cancer patients)
    - ORR per PCWG3 (in Phase 1 prostate cancer patients only)
    - Progression-free Survival (PFS), defined as the time from first dose to confirmed disease progression or death
    - Duration of response (DOR), defined as the time from the date of first response to the date of confirmed disease progression
    - Time to response (TTR), defined as the time from first dose to date of first response
    - Disease control rate, defined as the proportion of patients with a best overall response of complete response (CR), partial response (PR) or stable disease (SD)

    Phase 2:
    - PFS, defined as the time from first dose to confirmed disease progression or death
    - Time-to-progression
    - DOR, defined as the time from the date of first response to the date of confirmed disease progression
    - TTR, defined as the time from first dose to date of first response
    - Disease control rate, defined as the proportion of patients with a best overall response of complete response (CR), partial response (PR) or stable disease (SD)
    - ORR per GCIG-defined CA-125 response criteria (ovarian cancer patients)
    - Overall survival (OS), defined as the time from first dose to death
    - AEs and changes in laboratory values
    - PK and PD parameters
    E.5.2.1Timepoint(s) of evaluation of this end point
    End of study
    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 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 trial2
    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 EEA10
    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
    France
    Italy
    Poland
    Spain
    United Kingdom
    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 months3
    E.8.9.1In the Member State concerned days7
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months3
    E.8.9.2In all countries concerned by the trial days24
    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: 142
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 142
    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 state7
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 35
    F.4.2.2In the whole clinical trial 284
    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 Decision2021-03-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-07-07
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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