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TRUST-II: Taletrectinib Phase 2 Global Study in ROS1 Positive NSCLC

Sponsor
AnHeart Therapeutics Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04919811
Collaborator
(none)
119
Enrollment
38
Locations
1
Arm
69
Anticipated Duration (Months)
3.1
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The main purpose of the study is to evaluate safety and efficacy of taletrectinib (also known as AB-106 or DS-6051b) monotherapy in the treatment of advanced NSCLC.

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

This is a global Phase 2, multicenter, single-arm, open label study of taletrectinib in patients of NSCLC harboring with ROS1 fusion gene.

119 patients will be enrolled and divided into 4 cohorts, depending on past history of ROS1 TKI treatment.

Taletrectinib will be administered 600mg once daily in 21-day cycles. Patients will continue with the study treatment until progression of disease as determined by the investigator.

The tumor response evaluation will be conducted on a regular basis until progression of disease. Long-term survival follow up will be conducted as well.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
119 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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
Actual Study Start Date :
Sep 1, 2021
Anticipated Primary Completion Date :
Jun 1, 2025
Anticipated Study Completion Date :
Jun 1, 2027

Arms and Interventions

Arm Intervention/Treatment
Experimental: Taletrectinib

Single-arm trial whereby all consented, enrolled, eligible patients receive taletrectinib

Drug: Taletrectinib
600mg QD
Other Names:
  • DS-6051b
  • AB-106

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Objective response rate (ORR) by independent radiology review committee (IRC) [Up to 4 years]

      Confirmed ORR according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 assessed by an independent radiology review committee (IRC)

    Secondary Outcome Measures

    1. Progression-free survival (PFS) [Up to 4 years]

      PFS according to RECIST 1.1 assessed by IRC

    2. Objective response rate (ORR) assessed by investigators [Up to 4 years]

      ORR according to RECIST 1.1 assessed by investigators

    3. Safety and tolerability of taletrectinib [Up to 4 years]

      Incidence of Adverse events (AEs), incidence of laboratory abnormalities, incidence of abnormal vital signs, abnormal ECG and abnormal ophthalmologic findings

    4. Pharmacokinetic (PK) profile of taletrectinib [Up to 4 years]

      Maximum Plasma Concentration (Cmax) of taletrectinib

    Other Outcome Measures

    1. Intracranial progression-free survival (IC-PFS) [Up to 4 years]

      Confirmed IC-PFS per Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM) criteria

    2. Intracranial objective response rate (IC-ORR) [Up to 4 years]

      Confirmed IC-ORR per RANO-BM criteria

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    1. Patient age ≥18 years (or ≥20 years as required by local regulations).

    2. Histologically or cytologically confirmed diagnosis of locally advanced or metastatic NSCLC or other solid tumors.

    3. Evidence of ROS1 fusion in tumor tissue determined by molecular assays as performed in Clinical Laboratory Improvement Amendments (CLIA)-certified or locally equivalent laboratories.

    4. Patients with central nervous system (CNS) involvement, including leptomeningeal carcinomatosis, which is either asymptomatic or previously treated and controlled, are allowed; the use of seizure prophylaxis is allowed as long as patients are taking non enzyme inducing anti-epileptic drugs (non-EIAEDs). If corticosteroid treatment is required, it should be on stable or decreasing dose of ≤10 mg prednisone or equivalent. If patients have neurological symptoms or signs due to CNS metastasis, patients need to complete whole brain radiation or gamma knife irradiation treatment at least 14 days before enrollment and be clinically stable.

    5. The patient is either ROS1 TKI treatment naïve, or treated with prior ROS1 TKI(s).

    6. At least one extracranial measurable unirradiated lesion per RECIST 1.1 assessed by investigator.

    7. Eastern Cooperative Oncology Group Performance Status: 0 or 1.

    8. Patient with a life expectancy ≥12 weeks based on the judgement of investigators.

    9. Patients with adequate organ function meeting the following criteria:

    10. Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT): ≤3 × upper limit of normal (ULN) (or ≤5 × ULN, in case of liver abnormalities due to liver metastases)

    11. Serum total bilirubin: ≤1.5 × ULN

    12. Absolute neutrophil count: ≥1,500/μL

    13. Platelet count: ≥100,000/μL

    14. Hemoglobin: ≥ 9.0 g/dL

    15. Serum creatinine: ≤1.5 × ULN

    16. Males and/or females who meet any of the following criteria:

    17. For males (irrespective of surgical sterilization [vasectomy]): agree to use effective contraception methods during the study intervention period and for at least 90 days after the last dose of investigational drug or agree with complete abstinence;

    18. For females be post-menopausal for at least one year prior to screening or be documented surgically sterilized. Women of childbearing potential (WOCBP) must agree to use two concurrent effective methods of contraception or agree with complete abstinence from sexual intercourse since the informed consent until 90 days after the last dose of investigational drug. Usage of hormonotherapy for contraception should be recorded as well.

    19. The patient is willing and capable to give written informed consent.

    20. For all females of childbearing potential, a negative pregnancy test must be obtained within 7 days of initial administration.

    21. Willingness and ability to comply with the study scheduled visits, treatment plans, laboratory tests and other procedures.

    Exclusion Criteria:

    1. Investigational agent or anticancer therapy within 2 weeks (or 5 half-lives of the compound, whichever is longer) prior to study enrollment. In addition, no concurrent anticancer therapy is permitted.

    2. Previously treated with immuno-oncology (IO) including immune checkpoint inhibitors within 12 weeks before enrollment.

    3. Major surgery within 4 weeks prior to enrollment.

    4. Radiation therapy with a limited field for palliation within 1 week of the first dose of study treatment.

    5. Toxicities due to prior therapy are unresolved to ≤ CTCAE 5.0 Grade 1 except for AEs not constituting a safety risk to the patient based on the judgment of investigators.

    6. Patients with spinal cord compression caused by tumor and/or cancerous meningitis.

    7. History or evidence of interstitial fibrosis or interstitial lung disease or 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) or hepatitis C virus (HCV), known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness.

    10. Clinically significant cardiovascular diseases within 3 months prior to the first dose of investigational drug: myocardial infarction, severe/unstable angina, coronary/peripheral endovascular treatment, heart failure or cerebrovascular disorder including transient ischemic attack.

    11. Ongoing cardiac dysrhythmias of ≥ CTCAE 5.0 Grade 2, uncontrolled atrial fibrillation of any grade, or QT interval corrected for heart rate (QTc) interval >470 milliseconds (female) or QTc interval >450 milliseconds (male), or symptomatic bradycardia <45 beats per minute.

    12. Pregnancy or lactation.

    13. Patients with other severe medical or mental diseases in whom the risk is increased by the participation to the study or treatment with investigational drug in the opinion of the investigator.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Beverly Hills Cancer Center Beverly Hills California United States 90211
    2 Chao Family Comprehensive Cancer Center Orange California United States 92868
    3 UCI Medical Center Orange California United States 92868
    4 PMK Medical Group Inc Oxnard California United States 93030
    5 Ventura County Hematology-Oncology Specialists Oxnard California United States 93030
    6 American Institute of Research Whittier California United States 90211
    7 American Institute of Research Whittier California United States 90601
    8 Florida Cancer Specialists Bradenton Florida United States 34202
    9 SCRI - Florida Cancer Specialists South Fort Myers Florida United States 33901
    10 Memorial Healthcare System Hollywood Florida United States 33021
    11 Cancer Specialists of North Florida Jacksonville Florida United States 90603
    12 Cancer Specialists of North Florida Jacksonville Florida United States 92868
    13 Hematology Oncology Clinic Baton Rouge Louisiana United States 70809
    14 SCRI - Hematology Oncology Clinic Baton Rouge Louisiana United States 70809
    15 Cleveland Clinic Foundation Cleveland Ohio United States 44195
    16 Cleveland Clinic Cleveland Ohio United States 44195
    17 SCRI - Tennessee Oncology Nashville Tennessee United States 37203
    18 Renovatio Clinical Dallas Texas United States 75001
    19 Texas Oncology, P.A. Dallas Texas United States 75246
    20 Renovatio Clinical - The Woodlands Houston Texas United States 77056
    21 Renovatio Clinical The Woodlands Texas United States 77380
    22 SCRI - Texas Oncology The Woodlands Texas United States 77380
    23 Hunan Cancer Hospital Changsha China
    24 Hôpital Européen Georges Pompidou Paris France
    25 Fondazione Policlinico Universitario Agostino Gemelli IRCCS Roma Italy
    26 National Hospital Organization Kyushu Cancer Center Fukuoka Japan
    27 National Cancer Center Hospital East Kashiwa Japan
    28 Sendai Kousei Hospital Miyagi Japan
    29 Aichi Cancer Center Hospital Nagoya Japan
    30 Kindai University Hospital Osaka Japan
    31 Shizuoka Cancer Center Shizuoka Japan
    32 National Cancer Center Hospital Tokyo Japan
    33 The Cancer Institute Hospital of JFCR Tokyo Japan
    34 Pusan National University Hospital Busan Korea, Republic of 612-022
    35 Pusan National University Yangsan Hospital Gyeongsang Korea, Republic of 999007
    36 Chonnam National University Hwasun Hospital Hwasun Korea, Republic of 540-742
    37 Asan Medical Center Seoul Korea, Republic of 05742
    38 Korea University Guro Hospital Seoul Korea, Republic of 130-875

    Sponsors and Collaborators

    • AnHeart Therapeutics Inc.

    Investigators

    • Study Director: Study Director, AnHeart Therapeutics Inc.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    AnHeart Therapeutics Inc.
    ClinicalTrials.gov Identifier:
    NCT04919811
    Other Study ID Numbers:
    • AB-106-G208
    First Posted:
    Jun 9, 2021
    Last Update Posted:
    Jul 1, 2022
    Last Verified:
    Jun 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Carcinoma, Non-Small-Cell Lung

    Study Results

    No Results Posted as of Jul 1, 2022