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    Summary
    EudraCT Number:2021-003091-14
    Sponsor's Protocol Code Number:AB106G208
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2022-05-04
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2021-003091-14
    A.3Full title of the trial
    A Single-Arm, Open-Label, Multicenter Phase 2 Study to Evaluate the Efficacy and Safety of Taletrectinib in Patients with Advanced or Metastatic ROS1 Positive NSCLC and Other Solid Tumors
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to assess the effect of Taletrectinib in patients with advanced ROS1 Positive non- small cell lung cancer and Other Solid Tumors
    A.3.2Name or abbreviated title of the trial where available
    Taletrectinib in ROS1 Positive Lung Cancer Phase 2 Global Study (TRUST II)
    A.4.1Sponsor's protocol code numberAB106G208
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04919811
    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 SponsorAnHeart 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 supportAnHeart Therapeutics Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAnHeart Therapeutics
    B.5.2Functional name of contact pointPublic Relations
    B.5.3 Address:
    B.5.3.1Street Address777 Third Ave, Suite 1704
    B.5.3.2Town/ cityNY
    B.5.3.3Post code10017
    B.5.3.4CountryUnited States
    B.5.4Telephone number 917-388-3387
    B.5.5Fax number516-364-1845
    B.5.6E-mailpr@anhearttherapeutics.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 nameTaletrectinib
    D.3.2Product code AB-106 / DS-6051b
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTaletrectinib
    D.3.9.2Current sponsor codeAB-106
    D.3.9.3Other descriptive nameDS-6051b
    D.3.9.4EV Substance CodeSUB218609
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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
    Non Small Cell Lung Cancer
    E.1.1.1Medical condition in easily understood language
    Lung Cancer
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10029515
    E.1.2Term Non-small cell lung cancer recurrent
    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
    To evaluate the efficacy of taletrectinib by the objective response rate (ORR) in the patients with advanced or metastatic ROS1 positive NSCLC
    E.2.2Secondary objectives of the trial
    1. To evaluate the efficacy by duration of response (DOR)
    2. To evaluate the efficacy by progression-free survival (PFS)
    3. To evaluate the efficacy by time to treatment failure(TTF)
    4. To evaluate the efficacy by time to response(TTR)
    5. To evaluate the efficacy endpoints (ORR,DOR and PFS) assessed by
    investigators
    6. To evaluate the intracranial efficacy of taletrectinib
    7. To evaluate the efficacy by overall survival (OS)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age ≥18 years (or ≥20 years as required by local regulations)
    2. Histologically or cytologically confirmed diagnosis of locally advanced (including inoperable Stage IIIA or IIIB NSCLC) or metastatic NSCLC (cohorts 1-3, 5-6) or other solid tumors including NSCLC patients ineligible for other cohorts (cohort 4).
    3. Evidence of ROS1 fusion by a validated assay as performed in Clinical Laboratory Improvement Amendments (CLIA)-certified or locally equivalent diagnostic laboratories. The molecular assays (i.e., Reverse Transcription Polymerase Chain Reaction [RT-PCR], Next-generation Sequencing [NGS]) are highly recommended.
    4. Sufficient tumor tissue is required for patients in Cohort 1 and for TKInaïve patients in Cohort 5 in order to perform confirmatory ROS1 fusion testing at the designated central laboratories. For patients in cohort 1 and for TKI-naïve patients in Cohort 5, an archival tumor tissue
    specimen should be available and collected prior to enrollment. If archival tumor tissue is unavailable, then a fresh biopsy must be performed. Tumor tissue for patients in other cohorts is highly recommended and tumor tissue obtained after progression on the most recent prior ROS1 TKI therapy in these cohorts is preferred. Cytology samples (e.g., pleural effusion cell pellets) may be acceptable for patients in cohorts 2-4. Cohort 6, and patients in Cohort 5 that received prior treatment with TKI(s) having ROS1 activity.
    5. Patients with central nervous system (CNS) involvement, including leptomeningeal carcinomatosis, which is stable (either asymptomatic or previously treated and controlled), are allowed:
    • Seizure prophylaxis is permitted with non-enzyme inducing antiepileptic drugs (non-EIAEDs).
    • Corticosteroid treatment at a stable or decreasing dose of ≤10 mg prednisone or equivalent if required within 7 days prior to the first dose of taletrectinib.
    • Local therapy including but not limited to whole brain radiation or gamma knife irradiation treatment must be completed at least 14 days before enrollment and the patient clinically stable (e.g., no corticosteroids or anticonvulsant treatment) for 7 days prior to first dose of taletrectinib (for patients with neurological symptoms or signs due to CNS metastasis at screening).
    6. The patient is either ROS1 TKI treatment naïve, or treated with prior ROS1 TKI(s):
    • Cohort 1: Patients with locally advanced or metastatic ROS1-positive NSCLC. Systemic chemotherapy naïve or pretreated with 1 prior line of chemotherapy, but never treated with any ROS1 TKI.
    • Cohort 2: Patients with locally advanced or metastatic ROS1-positive NSCLC. Prior treatment with 1 approved ROS1 TKI (crizotinib or entrectinib) and disease progression. The patient can be either chemotherapy naïve or has received 1 line of systemic chemotherapy for the locally advanced or metastatic ROS1 positive NSCLC.
    • Cohort 3: Patients with locally advanced or metastatic ROS1-positive NSCLC. Prior treatment with ≥2 TKIs with ROS1 activity and disease progression. The patient can be either chemotherapy naïve or has received 1 line of systemic chemotherapy for locally advanced or metastatic ROS1-positive NSCLC, patients with known ROS1 resistant mutations are
    preferred.
    • Cohort 4: Patients with other ROS1-positive solid tumors, or NSCLC patients ineligible for Cohorts 1-3. Prior treatment with ≤3 TKIs with ROS1 activity. The patient can be either chemotherapy naïve or has received ≤ 2 lines of systemic chemotherapy for locally advanced or metastatic solid
    tumors.
    Cohort 5: Patients with locally advanced or metastatic ROS1-positive NSCLC. The patient can be either chemotherapy naïve or has received ≤2 lines of systemic chemotherapy line of systemic chemotherapy for locally advanced or metastatic ROS1-positive SCLC. ROS1-TKI-naïve or pretreated with TKI(s) having ROS1 activity.
    • Cohort 6: Patients with locally advanced or metastatic ROS1-positive NSCLC. Previously treated with ≥1 TKI having ROS1 activity. Prior adjuvant platinum-based chemotherapy and platinum-based chemotherapy for advanced or metastatic disease is allowed if completed >12 months from the study treatment start date with one exception: a patient may be eligible if started on chemotherapy, provided that no more than 2 cycles of chemotherapy were administered and no evidence of disease progression. 7. At least 1 measurable disease per RECIST 1.1 assessed by investigator.
    8. Eastern Cooperative Oncology Group Performance Status: 0 or 1.9. Patient with a life expectancy ≥12 weeks based on the judgment of investigator.
    10. Patients with adequate organ function meeting the following criteria:
    a) Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT): ≤ 3.0 × upper limit of normal (ULN) (or ≤ 5.0 × ULN, for patients with concurrent liver metastases)
    For full list of Inclusion criteria please see section 5.1 in Protocol
    E.4Principal exclusion criteria
    1. Treatment with small molecule anticancer therapy including other investigational agents or cytotoxic systemic anticancer therapy (with exceptions as noted in Inclusion Criterion 6 which requires at least 3 weeks washout), within 2 weeks (or 5 half-lives of the compound, whichever is shorter) prior to the first dose of taletrectinib; or treatment with monoclonal antibodies including immune checkpoint inhibitors, within 4 weeks before the first dose of taletrectinib.
    2. Major surgical procedure, open biopsy, or significant traumatic injury ≤4 weeks before the first dose of taletrectinib or anticipation of need for major surgical procedure during the study.
    • Placement of vascular access device is not considered major surgery.
    Other minor surgical procedures, such as catheter placement or
    minimally invasive biopsy, are allowed.
    3. Radiotherapy within 14 days before study treatment. Stereotactic radiosurgery (SRS), stereotactic radiation therapy (SRT), and palliative radiation outside the chest and brain are allowed but must be completed 1 week before starting study treatment.
    4. Have been diagnosed with another primary malignancy other than NSCLC except for adequately treated non-melanoma skin cancer or cervical cancer in situ; definitively treated non-metastatic prostate cancer; or patients with another primary malignancy who are definitively relapse-free with at least 3 years elapsed since initial diagnosis of the other malignancy. Note: This criterion does not apply to patients to be
    enrolled in Cohort 4.
    5. Adverse events due to prior therapy are unresolved to ≤ CTCAE Grade 1 or has not returned to baseline, at the time of the first dose of taletrectinib except for AEs not constituting a safety risk to the patient based on the judgment of investigators.
    6. Patients with untreated spinal cord compression caused by tumor and/or cancerous meningitis.
    7. History or evidence of interstitial fibrosis, interstitial lung disease or drug-induced pneumonitis (Excluding clinically insignificant or asymptomatic post-radiation pneumonitis).
    8. Any gastrointestinal disorders that may affect absorption of oral medications.
    9. Active and clinically significant bacterial, fungal, or viral infection including hepatitis B virus (HBV), hepatitis C virus (HCV), or severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness. Note that the following are permitted:
    • Patients treated for hepatitis C (HCV) or HIV with no detectable viral load; for at least 1 month prior to the first dose of taletrectinib. Note: caution with drug-drug interactions of concomitant anti-HIV agents and CYP3A substrates.
    • Patients with known hepatitis B (HBV) infections:
    - With past or resolved HBV infection (defined as the presence of hepatitis B core antibody [HBcAb] and absence of hepatitis B surface antigen [HBsAg]); or
    - With inactive HBV carrier state (defined as HBsAg-positive, with normal ALT, and HBV DNA <2,000 IU/mL or <10,000 copies/mL).
    Note: Please consider that for patients in an inactive HBV carrier state or with a resolved HBV infection, there may be a risk of HBV reactivation and anti-HBV prophylaxis should be considered.
    10. Clinically significant cardiovascular diseases within 3 months prior to the first dose of taletrectinib: myocardial infarction, severe/unstable angina, coronary/peripheral endovascular treatment, heart failure or cerebrovascular disorder including transient ischemic attack.
    11. Ongoing cardiac dysrhythmias of ≥ CTCAE Grade 2, uncontrolled atrial fibrillation of any grade, or QT interval corrected for heart rate by Fredericia's formula (QTcF) >470 milliseconds, or symptomatic bradycardia <45 beats per minute; patient has family or medical history of long QT syndrome.
    12. Pregnancy or lactation/breastfeeding.
    13. Use of food or drugs that are known potent cytochrome P450 3A4/5 (CYP3A4/5) inhibitors or inducers within 14 days prior to the first dose of study treatment and while on treatment.
    14. Administration of agents with potential QT interval prolonging effect within 14 days prior to first dose of study treatment and while on treatment.
    15. Patients with other severe medical or mental diseases in whom the risk is increased by the participation to the study or treatment with study treatment in the opinion of the Investigator.
    E.5 End points
    E.5.1Primary end point(s)
    Confirmed ORR according to Response Evaluation Criteria in Solid
    Tumors (RECIST) 1.1 assessed by IRC for cohorts 1-2.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Throughout the entire study period.
    E.5.2Secondary end point(s)
    1. DOR according to RECIST 1.1 assessed by IRC (cohorts 1-2)
    2. PFS according to RECIST 1.1 assessed by IRC (cohorts 1-2)
    3. TTF according to RECIST 1.1 assessed by IRC(cohorts 1-2)
    4. TTR according to RECIST 1.1 assessed by IRC(cohorts 1-2)
    5. ORR, DOR and PFS according to RECIST 1.1 assessed by investigators (cohorts 1-2)
    6. Confirmed intracranial (IC)-ORR, IC-DOR, IC-PFS and time to
    intracranial progression(TTiP) according to mRECIST 1.1 assessed by IRC (cohorts 1-2)
    7. OS (cohorts 1-2)
    E.5.2.1Timepoint(s) of evaluation of this end point
    •Efficacy: Throughout the entire study period.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    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) No
    E.7.1.1First administration to humans No
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA29
    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
    Ukraine
    Canada
    China
    Japan
    Korea, Republic of
    United States
    France
    Italy
    Poland
    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 years1
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    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: 92
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 62
    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 state3
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 70
    F.4.2.2In the whole clinical trial 154
    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)
    If the patient withdraws from the study before disease progression, a tumor evaluation should be performed every 12 weeks after the last dose, until disease progression or a new anti-cancer therapy is commenced. Follow up for survival will continue until death, withdrawal of informed consent, loss of follow-up and termination of the study by the sponsor, whichever occurs first.
    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 Decision2022-09-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-04-12
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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