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    Clinical Trial Results:
    A Phase 1-2 Study of Ti-061 Alone and in combination with other anti-cancer agents in Patients with Advanced Malignancies

    Summary
    EudraCT number
    		 2016-004372-22
    Trial protocol
    		 GB  
    Global end of trial date
    02 Aug 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    08 Aug 2018
    First version publication date
    08 Aug 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    Ti-061-101
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Tioma Therapeutics, Inc.
    Sponsor organisation address
    2000 Sierra Point Parkway, Suite 700, Brisbane, United States, CA 94005
    Public contact
    Clinical Trial Information Desk, Tioma Therapeutics, Inc., 001 4156714027, clinical@tiomatx.com
    Scientific contact
    Clinical Trial Information Desk, Tioma Therapeutics, Inc., 001 4156714027, clinical@tiomatx.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    29 May 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    02 Aug 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    02 Aug 2017
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    - To evaluate the safety and tolerability of Ti-061 in adult patients with advanced malignancies - To evaluate the safety and tolerability of Ti-061 combined with pembrolizumab in adult patients with advanced malignancies.
    Protection of trial subjects
    A DRC was established to monitor and evaluate the safety of patients and to maintain oversight of study data and monitoring process. If an infusion related reaction occurred, patients would be monitored until complete resolution of symptoms and treated as clinically indicated, including interruption and/or slowing of infusion rate as necessary. During the first treatment period, patients provided with a study information card to be carried at all times until completion of the follow-up visit.
    Background therapy
    		 None
    Evidence for comparator
    		 No comparator used
    Actual start date of recruitment
    15 Apr 2017
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 1
    Worldwide total number of subjects
    1
    EEA total number of subjects
    1
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    0
    From 65 to 84 years
    1
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Recruitment was initiated in the UK on 23 May 2017. Only one patient was recruited in the UK on 24 May 2017.

    Pre-assignment
    Screening details
    		 -

    Pre-assignment period milestones
    Number of subjects started
    		 2 [1]
    Number of subjects completed
    		 1

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 Screen failure: 1
    Notes
    [1] - The number of subjects reported to have started the pre-assignment period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: The pre-assignment period includes the patient numbers for the screening period – i.e. the number of patients who entered screening. The worldwide number enrolled in the trial is the number of patients who passed screening and were then enrolled into the trial.
    Period 1
    Period 1 title
    Treatment period (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    Open, no blinding

    Arms
    Arm title
    		 Part A - Ti-061
    Arm description
    		 Escalating repeat doses of Ti-061 monotherapy by intravenous administration to identify the maximum tolerated dose and recommended phase 2 dose, followed by expansion into 4 or more specific tumor type cohorts to examine preliminary efficacy and further document tolerability in patients with advanced malignancies
    Arm type
    		 Experimental

    Investigational medicinal product name
    Humanized monoclonal antibody targeting the CD47 cell surface protein
    Investigational medicinal product code
    Ti-061
    Other name
    None
    Pharmaceutical forms
    Solution for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Ti-061 was to be administered IV over at least 1 hour at escalating doses of 1 to 20 mg/kg weekly on days 1, 8 and 15 of each 3-week cycle or every 2 weeks on days 1 and 15 of each 4-week cycle in the exploratory Q2W cohort.

    Number of subjects in period 1
    		Part A - Ti-061
    Started
    1
    Completed
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Treatment period
    Reporting group description
    		 Ti-061 monotherapy

    Reporting group values
    		 Treatment period Total
    Number of subjects
    		 1 1
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 0 0
        From 65-84 years
    		 1 1
        85 years and over
    		 0 0
    Age continuous
    Units: years
        arithmetic mean (full range (min-max))
    		 73 (73 to 73) -
    Gender categorical
    Units: Subjects
        Female
    		 1 1
        Male
    		 0 0

    End points

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    End points reporting groups
    Reporting group title
    Part A - Ti-061
    Reporting group description
    		 Escalating repeat doses of Ti-061 monotherapy by intravenous administration to identify the maximum tolerated dose and recommended phase 2 dose, followed by expansion into 4 or more specific tumor type cohorts to examine preliminary efficacy and further document tolerability in patients with advanced malignancies

    Primary: Safety and tolerability of Ti-061 alone and in combination with pembrolizumab.

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    End point title
    		 Safety and tolerability of Ti-061 alone and in combination with pembrolizumab. [1]
    End point description
    Safety and tolerability of Ti-061 alone and in combination with pembrolizumabt - the primary analysis of safety was a comprehensive evaluation of AEs and/or toxicity, presented by dose, regimen and tumor type cohort and overall, based on: • Recording of AEs by CTCAE V4 • Recording of IRRs • Results of monitoring vital signs • Occurrence of late or cumulative AEs • Occurrence of autoimmune AEs • Results of clinical chemistry, hematology/coagulation, and urine analysis tests • ECG results • Changes in physical examination • Markers of inflammation and immunogenicity • Need for concomitant medications
    End point type
    Primary
    End point timeframe
    Ti-061 administered at escalating doses of 1-20mg/kg weekly on d1, 8 & 15 of each 3-wk cycle or every 2 wks on d1 & 15 of each 4-wk cycle in the exploratory Q2W cohort. If no MTD established 20mg/kg dose, higher doses up to 40mg/kg may have been explored
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical analysis was not appropriate for this end point, so was therefore not performed.
    End point values
    		 Part A - Ti-061
    Number of subjects analysed
    1
    Units: mg/kg
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    AEs and SAEs (including abnormal laboratory test results) will be collected from the time of signing the informed consent until 30 days after the last Ti-061 dose.
    Adverse event reporting additional description
    Only AEs/abnormalities occurring after the first dose of Ti-061 will be considered treatment-emergent.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.0
    Reporting groups
    Reporting group title
    Part A - Ti-061
    Reporting group description
    		 Escalating repeat doses of Ti-061 monotherapy by intravenous administration to identify the maximum tolerated dose and recommended phase 2 dose, followed by expansion into 4 or more specific tumor type cohorts to examine preliminary efficacy and further document tolerability in patients with advanced malignancies

    Serious adverse events
    		 Part A - Ti-061
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 1 (100.00%)
         number of deaths (all causes)
    1
         number of deaths resulting from adverse events
    1
    Vascular disorders
    Red blood cell agglutination
         subjects affected / exposed
    1 / 1 (100.00%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    1 / 1
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Part A - Ti-061
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 1 (100.00%)
    Investigations
    Transaminitis (transaminase increase)
         subjects affected / exposed
    1 / 1 (100.00%)
         occurrences all number
    1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 1 (100.00%)
         occurrences all number
    1
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    1 / 1 (100.00%)
         occurrences all number
    1
    Vomiting
         subjects affected / exposed
    1 / 1 (100.00%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    26 May 2017
    Notification of Substantial Amendment Number 1- Temporary halt of the trial

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    24 May 2017
    Only one patient was enrolled and treated in the trial; the patient completed the first study drug infusion but died on cycle 1, day 2, and the study was discontinued as a precautionary measure in light of this event.
    -

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    One patient enrolled, primary cause of death characterized as red cell agglutination. Sponsor considers this an important aspect, Sponsor would suggest that other aspects contributed to the patient’s death, including intravascular hemolytic anemia.
    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.

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