Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44341   clinical trials with a EudraCT protocol, of which   7370   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).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2021-001308-14
    Sponsor's Protocol Code Number:PT-112-101
    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:2021-09-01
    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 number2021-001308-14
    A.3Full title of the trial
    A Phase 1, Open-Label, Study Evaluating the Safety, Pharmacokinetics, and Clinical Effects of Intravenously Administered PT-112 Injection in Patients with Advanced Solid Tumors and Subsequent Expansion Cohorts
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study of PT-112 injection in patients with advanced tumors
    A.4.1Sponsor's protocol code numberPT-112-101
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02266745
    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 SponsorPromontory 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 supportPromontory Therapeutics Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPromontory Therapeutics Inc.
    B.5.2Functional name of contact pointClinical Operations
    B.5.3 Address:
    B.5.3.1Street Address1350 Avenue of the Americas, 23rd Fl.
    B.5.3.2Town/ cityNew York, NY
    B.5.3.3Post code10019
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1332-206-4039
    B.5.6E-mailclinops@promontorytx.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 namePT-112 Injection (5 mg/mL)
    D.3.2Product code PT-112
    D.3.4Pharmaceutical form Injection
    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 INNImifoplatin
    D.3.9.1CAS number 1339960-28-9
    D.3.9.2Current sponsor codePT-112
    D.3.9.4EV Substance CodeSUB204142
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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
    metastatic Castration-Resistant 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 20.0
    E.1.2Level SOC
    E.1.2Classification code 10029104
    E.1.2Term Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    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
    Expansion cohort D (metastatic Castration-Resistant Prostate Cancer): To define the recommended dose and schedule for PT-112 for pivotal studies, administered either as 250 mg/m2 on Days 1 and 15 of each 28-day cycle (Arm 2) or as 360 mg/m2 on Days 1 and 15 of Cycle 1, then 250 mg/m2 on Day 15 of each subsequent 28-day cycle (Arm 3), where the primary endpoint (benefit) is defined as DCR4.

    (Dose escalation and Cohorts A, B, and C have been closed).
    E.2.2Secondary objectives of the trial
    Expansion cohort D (metastatic Castration-Resistant Prostate Cancer): assess treatment effects on individual disease manifestations, evaluated overall and for each treatment arm: determine Disease control rate (DCR) by disease manifestation, ORR in patients with RECIST-measurable disease, median duration of response (DOR) for soft (non bone) tissue lesions, % of patients who are CTC nonzero at baseline and with 0 CTCs/mL in one or more post-baseline samples, % of patients who have ≥ 3 CTCs at baseline and ≤ 3 CTCs in one or more post-baseline samples, percentage of patients achieving PSA50, median radiographic progression-free survival (rPFS), median OS, time to PSA progression by PCWG3 criteria, change in disease-related pain, number of TRAEs as a measure of safety and tolerability, pharmacokinetics of PT-112 following dosing on Days 1 and 15 of Cycle 1, exposure-response and exposure-safety relationships for PT-112.
    (Dose escalation and Cohorts A, B, and C have been closed).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Expansion cohort D (metastatic Castration-Resistant Prostate Cancer):
    Documented current evidence of metastatic castration-resistant prostate cancer (mCRPC), Ongoing androgen deprivation therapy with a GnRH analog or a bilateral orchiectomy (i.e., surgical or medical castration), Serum testosterone level ≤ 1.73 nmol/L (50 ng/dL) at screening, Patients who have received at least three prior intended life-prolonging therapies for metastatic disease, Progressive disease at study entry, defined as either / both of the following criteria that occurred on or after the most recent therapy: soft-tissue disease progression, defined by RECIST v1.1, Bone disease progression, defined by PCWG3 as ≥ 2 new lesions confirmed on bone scan, Estimated life expectancy of ≥16 weeks, Adequate bone marrow, liver, and renal function, Must use a condom during study treatment and 6 months after the last dose of PT-112 when having intercourse with a pregnant woman or a woman of childbearing potential. Female partners of male patients also should use a highly effective form of contraception if they are of childbearing potential

    (Dose escalation and Cohorts A, B, and C have been closed).
    E.4Principal exclusion criteria
    Expansion cohort D (metastatic Castration-Resistant Prostate Cancer):
    Carcinomatous meningitis, Known brain metastases and/or active epidural disease (exceptions are described in protocol), Any minor surgical procedure within <5 days or any major surgical procedure within <28 days before the first dose of PT-112, Received treatment with chemotherapy, immunotherapy, gene therapy, vaccine therapy, angiogenesis inhibitors, radiation, experimental drug, or PARP inhibitors within ≤ 14 days of receiving the first dose of PT-112, Active infection requiring systemic therapy or significant acute or chronic infection including, among others Active hepatitis B virus (HBV) infection, Active hepatitis C virus (HCV) infection, Known history or testing positive for human immunodeficiency virus (HIV), Resting ECG indicating uncontrolled cardiac condition, including unstable ischemia, uncontrolled asymptomatic arrhythmia, congestive heart failure (New York Heart Association functional classification Grade II or higher), or QTcF prolongation >450 ms, or patients with congenital long QT syndrome.

    (Dose escalation and Cohorts A, B, and C have been closed).
    E.5 End points
    E.5.1Primary end point(s)
    Expansion cohort D (metastatic Castration-Resistant Prostate Cancer):
    Define the recommended dose and schedule for PT-112 for pivotal studies, administered either as 250 mg/m2 on Days 1 and 15 of each 28-day cycle (Arm 2) or as 360 mg/m2 on Days 1 and 15 of Cycle 1, then 250 mg/m2 on Day 15 of each subsequent 28-day cycle (Arm 3), where the primary endpoint (benefit) is defined as DCR4.
    E.5.1.1Timepoint(s) of evaluation of this end point
    End of study
    E.5.2Secondary end point(s)
    Expansion cohort D (metastatic Castration-Resistant Prostate Cancer):
    • Disease control rate (DCR) by disease manifestation, defined as follows:
    - For patients with RECIST-evaluable disease, the percentage of patients with confirmed complete response (CR), confirmed partial response (PR), or disease stabilization (SD) lasting at least 4 months, based on tumor assessments by CT with contrast at baseline and after every 2 cycles (8±1 weeks) of treatment, evaluated using PCWG3-modified RECIST criteria;
    - For patients with bone-only disease that is not measurable by RECIST, disease control will be assessed by disease stabilization, defined as the absence of progression for at least 4 months (or 4 months or greater), progression being defined by 2 or more new lesions on the 8-week and the 16-week technetium bone scan (to exclude flare), or the first appearance of 2 or more new lesions on a scan performed at week 16 or later, when compared to week 8 baseline, and confirmed subsequently. Scans should be performed at baseline and after every 2 cycles (8±1 weeks) of treatment through the first 6 months, and every 3 cycles (12±1 weeks) thereafter, and evaluated by PCWG3 criteria;
    • Objective response rate (ORR) in patients with RECIST-measurable disease, defined as the percentage of patients achieving a confirmed PR and CR, based on tumor assessments by CT with contrast at baseline and after every 2 cycles (8±1 weeks) of treatment through the first 6 months, then every 3 cycles (12±1 weeks), evaluated using PCWG3-modified RECIST criteria;
    • The median duration of response (DOR) for soft tissue (non bone) lesions, calculated as from the first observation of response to the first observation of disease progression using PCWG3-modified RECIST criteria;
    • Percentage of patients who are CTC nonzero at baseline and with 0 CTCs/mL in one or more post-baseline samples (i.e., CTC0);
    • Percentage of patients who have ≥ 3 CTCs at baseline and ≤ 3 CTCs in one or more post-baseline samples (i.e., CTC conversion);
    • Percentage of patients achieving PSA50 defined as ≥ 50% reduction in serum PSA from Cycle 1 Day 1 that is confirmed at the start of a subsequent cycle as defined by PCWG3 criteria;
    • Median radiographic progression-free survival (rPFS), calculated from the start of study drug to the first observation of radiographic disease progression by PCWG3 criteria;
    • Median overall survival (OS);
    • Time to PSA progression by PCWG3 criteria, calculated from the start of study drug to the first observation of PSA progression by PCWG3 criteria;
    • Change in disease-related pain, based on American Cancer Society Daily Pain Diary assessment of worst pain over the past 24 hours (11 point scale) and analgesic consumption
    • Number of treatment-related adverse events (TRAEs) as a measure of safety and tolerability;
    • Determine the pharmacokinetics of PT-112 following dosing on Days 1 and 15 of Cycle 1;
    • Assess exposure-response and exposure-safety relationships for PT-112;
    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 No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    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 No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Phase 1 study: only in the US
    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 No
    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
    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 years2
    E.8.9.1In the Member State concerned months8
    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 months10
    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: 18
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 72
    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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 15
    F.4.2.2In the whole clinical trial 109
    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)
    When the clinical study ends, the study doctor will discuss treatment choices with the trial participant.
    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 Decision2023-02-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-10-08
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Mon Jun 09 11:37:05 CEST 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA