A Phase II, Open Label, Multicenter Study to Evaluate the Efficacy and Safety of TT-00420 Tablet in Adult Patients With Advanced Cholangiocarcinoma

  • STATUS
    Recruiting
  • End date
    Sep 16, 2023
  • participants needed
    80
  • sponsor
    TransThera Sciences (Nanjing), Inc.
Updated on 16 September 2022
measurable disease
neutrophil count

Summary

This study is an open-label, multicenter study to evaluate the efficacy and safety of TT-00420 tablet in adult patients with advanced cholangiocarcinoma.

Description

This is a Phase II, open-label study to evaluate the efficacy and safety of TT00420 in patients with advanced/metastatic and surgically unresectable cholangiocarcinoma (CCA) with

  1. FGFR 2 fusions who failed prior FGFR inhibitor treatment, 2) FGFR2 fusions who responded on prior FGFR inhibitor treatment, 3) with other FGFR alterations, or 4) whose tumors do not contain a detectable FGFR alteration.

Details
Condition Cholangiocarcinoma, FGFR2 Fusion, FGFR2 Gene Mutation, FGFR1 Alteration, FGFR3 Alteration
Treatment TT-00420
Clinical Study IdentifierNCT04919642
SponsorTransThera Sciences (Nanjing), Inc.
Last Modified on16 September 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

≥ 18 years of age, at the time of signing informed consent
Histologically or cytologically documented advanced/metastatic or surgically unresectable cholangiocarcinoma who have received at least one line of prior systemic chemotherapy. Patients will be assigned to 1 of 4 cohorts
Cohort A1: FGFR2 fusions who have failed at least one previous treatment with an FGFR inhibitor
Cohort A2: FGFR2 fusions who have previously responded on at least one previous treatment with an FGFR inhibitor
Cohort B: other FGFR alterations, including FGFR2 mutations and FGFR1/3 alterations, including fusions
Cohort C: negative for FGFR alterations (FGFR wild-type)
At least one measurable lesion as defined by RECIST V1.1 criteria for solid tumors5
Documentation of FGFR gene alteration status
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Adequate organ function confirmed at screening and within 10 days of initiating treatment, as evidenced by
Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L
Hemoglobin (Hgb) ≥ 8 g/dl
Platelets (plt) ≥ 75 x 10^9/L
aspartate aminotransferase/serum glutamate oxaloacetate transaminase (AST/SGOT) and alanine aminotransferase/serum glutamate pyruvate transaminase (ALT/SGPT) ≤ 2.5 x Upper Limit of Normal (ULN) or ≤ 5.0 x ULN if liver metastases are present
Total bilirubin ≤ 1.5 x ULN
Calculated creatine clearance ≥ 50 mL/min (Cockcroft Gault formula
Negative pregnancy test within 72 hours before starting study treatment in all
premenopausal women and women < 12 months after the onset of menopause
Must agree to take sufficient contraceptive methods to avoid pregnancy (including male and female participants) during the study and until at least 6 months after ceasing study treatment
Able to sign informed consent and comply with the protocol

Exclusion Criteria

Women who are pregnant or lactating
Women of child-bearing potential (WOCBP) who do not use adequate birth control
Patients with untreated brain or central nervous system (CNS) metastases or brain/CNS metastases that have progressed (e.g. evidence of new or enlarging brain metastasis or new neurological symptoms attributable to brain/CNS metastases) Note: Patients with treated brain metastases that are off corticosteroids and have been clinically stable for 28 days are eligible for enrollment
Patients with a known concurrent malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, carcinoma in situ of the cervix or other noninvasive or indolent malignancy that has previously undergone potentially curative therapy
Patients with the following mood disorders as judged by the Investigator or a
psychiatrist
Medically documented history of or active major depressive episode, bipolar disorder (I or II), obsessive-compulsive disorder, schizophrenia; a history of suicidal attempt or ideation, or homicidal ideation (immediate risk of doing harm to others)
≥ CTCAE grade 3 anxiety
Impaired cardiac function or significant diseases, including but not limited to any of
the following
left ventricular ejection fraction (LVEF) < 45% as determined by multigated acquisition (MUGA) scan or echocardiogram (ECHO)
Congenital long QT syndrome
QTcF ≥ 480 msec on screening ECG
Unstable angina pectoris ≤ 3 months prior to starting study drug
Acute myocardial infarction ≤ 3 months prior to starting study drug
Patients with uncontrolled hypertension (defined as blood pressure of ≥ 150 mmHg
systolic and/or ≥ 90 mmHg diastolic at Screening)
Patients with
unresolved diarrhea ≥ CTCAE grade 2, or
impairment of gastrointestinal (GI) function, or
GI disease that may significantly alter the absorption of TT-00420
Other concurrent severe and/or uncontrolled concomitant medical conditions (e.g
uncontrolled hypertriglyceridemia [triglycerides > 500 mg/dL], or active or
uncontrolled infection) that could cause unacceptable safety risks or
compromise compliance with the protocol
Patients who have received chemotherapy, targeted therapy, or immunotherapy ≤ 5 half-lives or 3 weeks, whichever is shorter, (6 weeks for nitrosourea or mitomycin-C) prior to starting study drug
Patients who have received wide field radiotherapy ≤ 4 weeks or limited field radiation for palliation ≤ 2 weeks prior to starting study drug or who have not recovered from adverse events of prior therapy
Patients who have undergone major surgery ≤ 4 weeks prior to starting study drug or who have not recovered from adverse events of prior therapy
Patients who are currently receiving treatment with therapeutic doses of warfarin sodium (Coumadin®) or any other coumarin-derivative anticoagulants
Patients who are currently receiving treatment with strong CYP3A inhibitors or inducers, or sensitive substrates of CYP3A4 ≤ 2 weeks prior to starting study drug
Patients who are using a proton pump inhibitor within 4 days prior to the start of study therapy or a histamine-2 blocker within 2 days prior to the start of study therapy
Known diagnosis of human immunodeficiency virus (HIV) infection (HIV testing is not mandatory; patients with well controlled HIV might be enrolled per investigator's discretion and Sponsor approval)
Evidence of active infection with Hepatitis B or Hepatitis C that is not adequately controlled. For patients with known prior history of Hepatitis B or Hepatitis C, enrollment may be allowed per investigator's discretion and Sponsor approval
Inability to swallow or tolerate oral medication
Has a history or current evidence of any condition, therapy, or laboratory abnormality that, in the opinion of the investigator, might confound the results of the trial, interfere with the patient's safe participation and compliance in the trial
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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