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Study of RET Inhibitor TAS0953/HM06 in Patients With Advanced Solid Tumors With RET Gene Abnormalities ((MARGARET))

Primary Purpose

RET-altered Non Small Cell Lung Cancer, RET-altered Solid Tumors

Status
Recruiting
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
TAS0953/HM06
TAS0953/HM06
Sponsored by
Helsinn Healthcare SA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for RET-altered Non Small Cell Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Phase I - Common inclusion criteria for Dose-Escalation / Dose-Expansion:

  • Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1
  • Available RET-gene abnormalities determined on tissue or liquid biopsy
  • Documented progression of disease following existing therapies deemed by the Investigator to have demonstrated clinical benefit or unable to receive such therapies.
  • Adequate hematopoietic, hepatic and renal function

Phase I Dose-Escalation - Specific inclusion criteria:

  • Advanced solid tumors
  • Measurable and/or non-measurable disease as determined by RECIST 1.1
  • If patient has brain and/or leptomeningeal metastases, (s)he should be asymptomatic.

Phase I Dose-Expansion - Specific inclusion criteria:

  • Locally advanced or metastatic non small cell lung cancer (NSCLC) patients with primary RET gene fusion and prior exposure to RET selective inhibitors
  • Measurable disease as determined by RECIST 1.1
  • If patient has brain and/or leptomeningeal metastases,(s)he should have:

    • asymptomatic untreated brain/leptomeningeal metastases off steroids and anticonvulsant for at least 7 days or
    • asymptomatic brain metastases already treated with local therapy and be clinically stable on steroids and anticonvulsant for at least 7 days before study drug administration.

Phase II :

  • Available RET-gene abnormalities determined on tissue or liquid biopsy
  • Locally advanced or metastatic:

    • NSCLC patients with primary RET gene fusion and prior exposure to RET selective inhibitors;
    • NSCLC patients with RET gene fusion and without prior exposure to RET selective inhibitors
    • patients with advanced solid tumors that harbour RET gene abnormalities (other than NSCLC patients with primary RET gene fusions) and has failed all the available therapeutic options
  • Eastern Cooperative Oncology Group (ECOG) performance score of 0-2
  • Measurable disease as determined by RECIST 1.1
  • If patient has brain and/or leptomeningeal metastases,(s)he should have:

    • asymptomatic untreated brain/leptomeningeal metastases off steroids and anticonvulsant for at least 7 days or
    • asymptomatic brain metastases already treated with local therapy and be clinically stable on steroids and anticonvulsant for at least 7 days before study drug administration.
  • Adequate hematopoietic, hepatic and renal function

Exclusion Criteria:

Common exclusion criteria for Phase 1 and Phase 2

  • Investigational agents or anticancer therapy within 5 half-lives prior to the first dose of study drug
  • Major surgery (excluding placement of vascular access) within 4 weeks prior to the first dose of study drug or planned major surgery during the course of study treatment.
  • Whole Brain Radiotherapy within 14 days or other palliative radiotherapy within 7 days prior to the first dose of study drug, or persisting side effects of such therapy, in the opinion of the Investigator.
  • Clinically significant, uncontrolled, cardiovascular disease including myocardial infarction within 3 months prior to Day 1 of Cycle 1, unstable angina pectoris, significant valvular or pericardial disease, history of ventricular tachycardia, symptomatic Congestive Heart Failure (CHF) New York Heart Association (NYHA) class III-IV, and severe uncontrolled arterial hypertension, according to the Investigator's opinion.
  • QT interval corrected using Fridericia's formula (QTcF) >470 msec; personal or family history of prolonged QT syndrome or history of Torsades de pointes (TdP). History of risk factors for TdP
  • Treatment with strong CYP3A4 inhibitors within 1 week prior to the first dose of study drug or strong CYP3A4 inducers within 3 weeks prior to the first dose of study drug.

Phase I Dose-Expansion - and Phase II specific exclusion criteria:

  • Presence of known EGFR, KRAS, ALK, HER2, ROS1, BRAF and METex14 activating mutations.

Sites / Locations

  • Chao Family Comprehensive Cancer CenterRecruiting
  • Stanford Cancer CenterRecruiting
  • Massachusetts General HospitalRecruiting
  • Henry Ford HospitalRecruiting
  • START Midwest - Cancer & Hematology Centers of Western MichiganRecruiting
  • Laura and Isaac Perlmutter Cancer Center at NYU Langone HealthRecruiting
  • Memorial Sloan Kettering Cancer CenterRecruiting
  • The Sarah Cannon Research Institute/Tennessee OncologyRecruiting
  • The University of Texas M. D. Anderson Cancer CenterRecruiting
  • National Cancer Center Hospital EastRecruiting
  • National Cancer Center HospitalRecruiting
  • The Cancer Institute Hospital of JFCRRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

TAS0953/HM06 Phase 1

TAS0953/HM06 Phase 2

Arm Description

Dose escalation and dose expansion until recommended Phase 2 dose determined

Treatment phase at recommended Phase 2 dose in three different populations

Outcomes

Primary Outcome Measures

Phase 1 (dose-escalation): Maximum Tolerated Dose (MTD)
Incidence rate and category of dose limiting toxicities (DLTs)
Phase 1 (dose-expansion): Recommended Phase 2 dose (RP2D)
Phase 2: Objective Response Rate (ORR) by independent data monitoring committee (IDMC)
Proportion of patients with confirmed complete response (CR) and or partial response (PR) according to RECIST 1.1 as assessed by IDMC

Secondary Outcome Measures

Phase 1 (dose expansion): Objective Response Rate (ORR) by IDMC
Proportion of patients with confirmed complete response (CR) and or partial response (PR) according to RECIST 1.1 as assessed by IDMC
Phase 2: ORR by Investigator
Proportion of patients with confirmed complete response (CR) and or partial response (PR) according to RECIST 1.1 as assessed by Investigator
Phase 2: Disease Control Rate (DCR)
Proportion of patients with confirmed complete response (CR), partial response (PR) and Stable Disease according to RECIST 1.1 as assessed by Investigator
Phase 2: Time to Tumor Response (TTR)
Time from first dose to first documentation of objective tumor response (CR or PR)
Phase 2: Progression Free Survival (PFS)
Time from first dose to first documentation of objective disease progression or to death due to any cause, whichever occurs first
Phase 2: Time to Progression (TTP)
Time from first dose to objective tumor progression
Phase 2: Duration of Response (DOR)
Time from first documentation of tumor response (CR + PR) to disease progression or death due any cause whichever occurs first
Phase 2: Overall Survival (OS)
Time from first dose to date of death due to any cause
Phase 2: Central Nervous System (CNS) ORR (C-ORR)
Rate of confirmed CR and PR relative to patients with brain lesions at study entry
Phase 2: Central Nervous System DOR (C-DOR)
Time from documentation of intracranial tumor response to disease progression or death due to any cause whichever occurs first
Phase 2: Time to CNS progression
Time from the first dose to the first radiological evidence of CNS disease progression
Phase 1 (dose-escalation): Area under the plasma concentration versus time curve from time 0 to 12 hours (AUC0-12)
Phase 1 (dose-escalation): AUC0-24
Phase 1 (dose-escalation): AUC0-infinity
Phase 1 (dose-escalation): AUC0-12 at steady state
Phase 1 (dose-escalation): Maximum drug concentration (Cmax)
Phase 1 (dose-escalation): Trough drug concentration at 12 hours (Ctrough)
Phase 1 (dose-escalation): Time to maximum plasma concentration (tmax)
Phase 1 (dose-escalation): Terminal half-life (t1/2)
Phase 1 (dose-escalation): Accumulation factor based on Cmax (Rmax)
Phase 1 (dose-escalation): Accumulation factor based on Ctrough (Rmin)
Phase 1 (dose-escalation): Terminal rate constant (lambda_z)
Phase 1 (dose-escalation): Volume of Distribution (Vz/F)
Phase 1 (dose-escalation): Systemic clearance (CL/F)
Phase 1 (dose-escalation): Amount excreted in 0-24 hour urine (Ae0-24)
Phase 1 (dose-escalation): Renal Clearance (CL_R)
Phase 1 (dose-expansion): AUC0-12 at steady state
Phase 1 (dose-expansion): Maximum drug concentration (Cmax)
Phase 1 (dose-expansion): Trough drug concentration at 12 hours (Ctrough)
Phase 1 (dose-expansion): Time to maximum plasma concentration (tmax)
Phase 1 (dose-expansion): Terminal rate constant (lambda_z)
Phase 1 (dose-expansion): Terminal half-life (t1/2)
Phase 2 Population PK: Typical value of absorption rate constant (Ka)
Phase 2 Population PK: Typical value of CL/F
Phase 2 Population PK: Typical value of volume of distribution (V/F)
Phase 1: Incidence of abnormal electrocardiograms (ECG QT interval). QT will be corrected for heart rate (QTc) using Fridericia's formula (QTcF).
Phase 1: Incidence of treatment-emergent adverse events (TEAEs)
Phase 1: Incidence of serious adverse events (SAEs)
Phase 2: Incidence of abnormal electrocardiograms (ECG QT interval). QT will be corrected for heart rate (QTc) using Fridericia's formula (QTcF).
Phase 2: Incidence of treatment-emergent adverse events (TEAEs)
Phase 2: Incidence of serious adverse events (SAEs)

Full Information

First Posted
December 4, 2020
Last Updated
March 2, 2023
Sponsor
Helsinn Healthcare SA
Collaborators
ICON Clinical Research
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1. Study Identification

Unique Protocol Identification Number
NCT04683250
Brief Title
Study of RET Inhibitor TAS0953/HM06 in Patients With Advanced Solid Tumors With RET Gene Abnormalities
Acronym
(MARGARET)
Official Title
Phase I/II Study of the Selective RET Inhibitor TAS0953/HM06 in Patients With Advanced Solid Tumors With RET Gene Abnormalities
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 16, 2020 (Actual)
Primary Completion Date
March 2025 (Anticipated)
Study Completion Date
September 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Helsinn Healthcare SA
Collaborators
ICON Clinical Research

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Phase 1 and 2 trial to study the safety, pharmacokinetics, and efficacy of TAS0953/HM06 in patients with advanced solid tumors with RET gene abnormalities. Phase 1 aims to determine the Maximum Tolerated Dose (MTD) and identify the Recommended Phase 2 Dose (RP2D) to be used in phase 2.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
RET-altered Non Small Cell Lung Cancer, RET-altered Solid Tumors

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Sequential Assignment
Model Description
Dose escalation phase followed by a dose expansion phase (Phase 1), then followed by a Phase 2 at the recommended dose
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
202 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TAS0953/HM06 Phase 1
Arm Type
Experimental
Arm Description
Dose escalation and dose expansion until recommended Phase 2 dose determined
Arm Title
TAS0953/HM06 Phase 2
Arm Type
Experimental
Arm Description
Treatment phase at recommended Phase 2 dose in three different populations
Intervention Type
Drug
Intervention Name(s)
TAS0953/HM06
Intervention Description
Phase 1: oral, starting dose 20mg twice a day, until recommended phase 2 dose, continuous daily dosing, cycles lasting 21 days
Intervention Type
Drug
Intervention Name(s)
TAS0953/HM06
Intervention Description
Phase 2: oral, recommended dose twice a day, continuous daily dosing, cycles lasting 21 days
Primary Outcome Measure Information:
Title
Phase 1 (dose-escalation): Maximum Tolerated Dose (MTD)
Description
Incidence rate and category of dose limiting toxicities (DLTs)
Time Frame
At the end of Cycle 1 (each cycle is 21 days)
Title
Phase 1 (dose-expansion): Recommended Phase 2 dose (RP2D)
Time Frame
At the end of Cycle 1 (each cycle is 21 days), and at the end of every subsequent cycle (each cycle is 21 days) for approximately 10 months (or earlier if patient discontinues the study)
Title
Phase 2: Objective Response Rate (ORR) by independent data monitoring committee (IDMC)
Description
Proportion of patients with confirmed complete response (CR) and or partial response (PR) according to RECIST 1.1 as assessed by IDMC
Time Frame
Approximately every 6 weeks for 6 months, then every 9 weeks during treatment, 7 days after the last dose, and every 3 months after the last dose (up to an average of 2 years) in patients without progressive disease.
Secondary Outcome Measure Information:
Title
Phase 1 (dose expansion): Objective Response Rate (ORR) by IDMC
Description
Proportion of patients with confirmed complete response (CR) and or partial response (PR) according to RECIST 1.1 as assessed by IDMC
Time Frame
Approximately every 6 weeks for 6 months, then every 9 weeks during treatment, 7 days after the last dose, and every 3 months after the last dose (up to an average of 2 years) in patients without progressive disease
Title
Phase 2: ORR by Investigator
Description
Proportion of patients with confirmed complete response (CR) and or partial response (PR) according to RECIST 1.1 as assessed by Investigator
Time Frame
Approximately every 6 weeks for 6 months, then every 9 weeks during treatment, 7 days after the last dose, and every 3 months after the last dose (up to an average of 2 years) in patients without progressive disease
Title
Phase 2: Disease Control Rate (DCR)
Description
Proportion of patients with confirmed complete response (CR), partial response (PR) and Stable Disease according to RECIST 1.1 as assessed by Investigator
Time Frame
Approximately every 6 weeks for 6 months, then every 9 weeks during treatment, 7 days after the last dose, and every 3 months after the last dose (up to an average of 2 years) in patients without progressive disease
Title
Phase 2: Time to Tumor Response (TTR)
Description
Time from first dose to first documentation of objective tumor response (CR or PR)
Time Frame
From date of randomization until the date of first documentation of objective tumor response, assessed up to an average of 2 years.
Title
Phase 2: Progression Free Survival (PFS)
Description
Time from first dose to first documentation of objective disease progression or to death due to any cause, whichever occurs first
Time Frame
From date of randomization until the date of first documented progression or death due to any cause, whichever occurs first, assessed up to an average of 2 years.
Title
Phase 2: Time to Progression (TTP)
Description
Time from first dose to objective tumor progression
Time Frame
From date of randomization until the date of first documented progression, assessed up to an average of 2 years
Title
Phase 2: Duration of Response (DOR)
Description
Time from first documentation of tumor response (CR + PR) to disease progression or death due any cause whichever occurs first
Time Frame
From first documentation of objective tumor response (CR or PR) until the date of first documented progression or death due to any causes, whichever occurs first, assessed up to an average of 2 years
Title
Phase 2: Overall Survival (OS)
Description
Time from first dose to date of death due to any cause
Time Frame
From date of randomization until the date of death due to any cause, assessed up to an average of 2 years
Title
Phase 2: Central Nervous System (CNS) ORR (C-ORR)
Description
Rate of confirmed CR and PR relative to patients with brain lesions at study entry
Time Frame
Approximately every 6 weeks for 6 months, then every 9 weeks during treatment, 7 days after the last dose, and every 3 months after the last dose (up to an average of 2 years) in patients without progressive disease
Title
Phase 2: Central Nervous System DOR (C-DOR)
Description
Time from documentation of intracranial tumor response to disease progression or death due to any cause whichever occurs first
Time Frame
From first documentation of objective tumor response (CR or PR) until the date of first documented progression or death due to any causes, whichever occurs first, assessed up to an average of 2 years
Title
Phase 2: Time to CNS progression
Description
Time from the first dose to the first radiological evidence of CNS disease progression
Time Frame
From date of randomization until the date of first documented progression, assessed up to an average of 2 years
Title
Phase 1 (dose-escalation): Area under the plasma concentration versus time curve from time 0 to 12 hours (AUC0-12)
Time Frame
Day -1 of Cycle 1 (each cycle is 21 days)
Title
Phase 1 (dose-escalation): AUC0-24
Time Frame
Day -1 of Cycle 1 (each cycle is 21 days)
Title
Phase 1 (dose-escalation): AUC0-infinity
Time Frame
Day -1 of Cycle 1 (each cycle is 21 days)
Title
Phase 1 (dose-escalation): AUC0-12 at steady state
Time Frame
Day 15 of Cycle 1 (each cycle is 21 days)
Title
Phase 1 (dose-escalation): Maximum drug concentration (Cmax)
Time Frame
Day -1 and Day 15 of Cycle 1 (each cycle is 21 days)
Title
Phase 1 (dose-escalation): Trough drug concentration at 12 hours (Ctrough)
Time Frame
Day -1 and Day 15 of Cycle 1 (each cycle is 21 days)
Title
Phase 1 (dose-escalation): Time to maximum plasma concentration (tmax)
Time Frame
Day -1 and Day 15 of Cycle 1 (each cycle is 21 days)
Title
Phase 1 (dose-escalation): Terminal half-life (t1/2)
Time Frame
Day -1 and Day 15 of Cycle 1 (each cycle is 21 days)
Title
Phase 1 (dose-escalation): Accumulation factor based on Cmax (Rmax)
Time Frame
Day 15 of Cycle 1 (each cycle is 21 days)
Title
Phase 1 (dose-escalation): Accumulation factor based on Ctrough (Rmin)
Time Frame
Day 15 of Cycle 1 (each cycle is 21 days)
Title
Phase 1 (dose-escalation): Terminal rate constant (lambda_z)
Time Frame
Day -1 and Day 15 of Cycle 1 (each cycle is 21 days)
Title
Phase 1 (dose-escalation): Volume of Distribution (Vz/F)
Time Frame
Day -1 and Day 15 of Cycle 1 (each cycle is 21 days)
Title
Phase 1 (dose-escalation): Systemic clearance (CL/F)
Time Frame
Day -1 and Day 15 of Cycle 1 (each cycle is 21 days)
Title
Phase 1 (dose-escalation): Amount excreted in 0-24 hour urine (Ae0-24)
Time Frame
Day -1 of Cycle 1 (each cycle is 21 days)
Title
Phase 1 (dose-escalation): Renal Clearance (CL_R)
Time Frame
Day -1 of Cycle 1 (each cycle is 21 days)
Title
Phase 1 (dose-expansion): AUC0-12 at steady state
Time Frame
Day 8 and Day 15 of Cycle 1 (each cycle is 21 days)
Title
Phase 1 (dose-expansion): Maximum drug concentration (Cmax)
Time Frame
Day 8 and Day 15 of Cycle 1 (each cycle is 21 days)
Title
Phase 1 (dose-expansion): Trough drug concentration at 12 hours (Ctrough)
Time Frame
Day 8 and Day 15 of Cycle 1 (each cycle is 21 days)
Title
Phase 1 (dose-expansion): Time to maximum plasma concentration (tmax)
Time Frame
Day 8 and Day 15 of Cycle 1 (each cycle is 21 days)
Title
Phase 1 (dose-expansion): Terminal rate constant (lambda_z)
Time Frame
Day 8 and Day 15 of Cycle 1 (each cycle is 21 days)
Title
Phase 1 (dose-expansion): Terminal half-life (t1/2)
Time Frame
Day 8 and Day 15 of Cycle 1 (each cycle is 21 days)
Title
Phase 2 Population PK: Typical value of absorption rate constant (Ka)
Time Frame
Day 15 of Cycle 1 (each cycle is 21 days)
Title
Phase 2 Population PK: Typical value of CL/F
Time Frame
Day 15 of Cycle 1 (each cycle is 21 days)
Title
Phase 2 Population PK: Typical value of volume of distribution (V/F)
Time Frame
Day 15 of Cycle 1 (each cycle is 21 days)
Title
Phase 1: Incidence of abnormal electrocardiograms (ECG QT interval). QT will be corrected for heart rate (QTc) using Fridericia's formula (QTcF).
Time Frame
On Day 1, Day 8 (only in dose escalation), Day 15 in cycle 1, Day 1 of any subsequent cycles (each cycle is 21 days) during treatment, for approximately 10 months (or earlier if the patient discontinues from the study), and 7 days after last dose
Title
Phase 1: Incidence of treatment-emergent adverse events (TEAEs)
Time Frame
From the time of informed consent, for approximately 10 months (or earlier if the patient discontinues from the study), and through Safety Follow-up (28 days after the last dose)
Title
Phase 1: Incidence of serious adverse events (SAEs)
Time Frame
From the time of informed consent, for approximately 10 months (or earlier if the patient discontinues from the study), and through Safety Follow-up (28 days after the last dose)
Title
Phase 2: Incidence of abnormal electrocardiograms (ECG QT interval). QT will be corrected for heart rate (QTc) using Fridericia's formula (QTcF).
Time Frame
On Day 1 and Day 15 in cycle 1, Day 1 of any subsequent cycles (each cycle is 21 days) during treatment, for approximately 2 years (or earlier if the patient discontinues from the study), and 7 days after last dose
Title
Phase 2: Incidence of treatment-emergent adverse events (TEAEs)
Time Frame
From the time of informed consent for approximately 2 years (or earlier if the patient discontinues from the study), and through Safety Follow-up (28 days after the last dose)
Title
Phase 2: Incidence of serious adverse events (SAEs)
Time Frame
From the time of informed consent for approximately 2 years (or earlier if the patient discontinues from the study), and through Safety Follow-up (28 days after the last dose)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Phase I - Common inclusion criteria for Dose-Escalation / Dose-Expansion: Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1 Available RET-gene abnormalities determined on tissue or liquid biopsy Documented progression of disease following existing therapies deemed by the Investigator to have demonstrated clinical benefit or unable to receive such therapies. Adequate hematopoietic, hepatic and renal function Phase I Dose-Escalation - Specific inclusion criteria: Advanced solid tumors Measurable and/or non-measurable disease as determined by RECIST 1.1 If patient has brain and/or leptomeningeal metastases, (s)he should be asymptomatic. Phase I Dose-Expansion - Specific inclusion criteria: Locally advanced or metastatic non small cell lung cancer (NSCLC) patients with primary RET gene fusion and prior exposure to RET selective inhibitors Measurable disease as determined by RECIST 1.1 If patient has brain and/or leptomeningeal metastases,(s)he should have: asymptomatic untreated brain/leptomeningeal metastases off steroids and anticonvulsant for at least 7 days or asymptomatic brain metastases already treated with local therapy and be clinically stable on steroids and anticonvulsant for at least 7 days before study drug administration. Phase II : Available RET-gene abnormalities determined on tissue or liquid biopsy Locally advanced or metastatic: NSCLC patients with primary RET gene fusion and prior exposure to RET selective inhibitors; NSCLC patients with RET gene fusion and without prior exposure to RET selective inhibitors patients with advanced solid tumors that harbour RET gene abnormalities (other than NSCLC patients with primary RET gene fusions) and has failed all the available therapeutic options Eastern Cooperative Oncology Group (ECOG) performance score of 0-2 Measurable disease as determined by RECIST 1.1 If patient has brain and/or leptomeningeal metastases,(s)he should have: asymptomatic untreated brain/leptomeningeal metastases off steroids and anticonvulsant for at least 7 days or asymptomatic brain metastases already treated with local therapy and be clinically stable on steroids and anticonvulsant for at least 7 days before study drug administration. Adequate hematopoietic, hepatic and renal function Exclusion Criteria: Common exclusion criteria for Phase 1 and Phase 2 Investigational agents or anticancer therapy within 5 half-lives prior to the first dose of study drug Major surgery (excluding placement of vascular access) within 4 weeks prior to the first dose of study drug or planned major surgery during the course of study treatment. Whole Brain Radiotherapy within 14 days or other palliative radiotherapy within 7 days prior to the first dose of study drug, or persisting side effects of such therapy, in the opinion of the Investigator. Clinically significant, uncontrolled, cardiovascular disease including myocardial infarction within 3 months prior to Day 1 of Cycle 1, unstable angina pectoris, significant valvular or pericardial disease, history of ventricular tachycardia, symptomatic Congestive Heart Failure (CHF) New York Heart Association (NYHA) class III-IV, and severe uncontrolled arterial hypertension, according to the Investigator's opinion. QT interval corrected using Fridericia's formula (QTcF) >470 msec; personal or family history of prolonged QT syndrome or history of Torsades de pointes (TdP). History of risk factors for TdP Treatment with strong CYP3A4 inhibitors within 1 week prior to the first dose of study drug or strong CYP3A4 inducers within 3 weeks prior to the first dose of study drug. Phase I Dose-Expansion - and Phase II specific exclusion criteria: Presence of known EGFR, KRAS, ALK, HER2, ROS1, BRAF and METex14 activating mutations.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michael Karl
Phone
+49 8709 943 761
Email
Michael.Karl@iconplc.com
Facility Information:
Facility Name
Chao Family Comprehensive Cancer Center
City
Orange
State/Province
California
ZIP/Postal Code
92868-3298
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sai-Hong Ignatius Ou, MD PhD
Email
ignatius.ou@uci.edu
Facility Name
Stanford Cancer Center
City
Stanford
State/Province
California
ZIP/Postal Code
94305-5826
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Heather Ann Wakelee, MD
Email
hwakelee@stanford.edu
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Justin Gainor, MD
Phone
617-724-4000
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shirish Madhav Gadgeel, MD
Email
sgadgee1@hfhs.org
Facility Name
START Midwest - Cancer & Hematology Centers of Western Michigan
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49546
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nehal Lakani, MD
Email
nehal.lakhani@startmidwest.com
Facility Name
Laura and Isaac Perlmutter Cancer Center at NYU Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vamsidhar Velcheti, MD
Phone
212-731-5662
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexander Dela Cruz Drilon, MD
Phone
833-401-5560
Facility Name
The Sarah Cannon Research Institute/Tennessee Oncology
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Melissa Johnson, MD
Email
mjohnson@tnonc.com
Facility Name
The University of Texas M. D. Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-4009
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vivek Subbiah, MD
Email
vsubbiah@mdanderson.org
Facility Name
National Cancer Center Hospital East
City
Kashiwa-shi
State/Province
Chiba
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kiyotaka Yoh, MD
Email
kyoh@east.ncc.go.jp
Facility Name
National Cancer Center Hospital
City
Chuo-ku
State/Province
Tokyo
ZIP/Postal Code
104-0045
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuki Shinno, MD
Facility Name
The Cancer Institute Hospital of JFCR
City
Koto-ku
State/Province
Tokyo
ZIP/Postal Code
135-8550
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shunji Takahashi, MD

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Study of RET Inhibitor TAS0953/HM06 in Patients With Advanced Solid Tumors With RET Gene Abnormalities

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