Study to Evaluate the Efficacy and Safety of TT-00420 (Tinengotinib) in Cholangiocarcinoma

Completed · Phase 2

Conditions studied: Cholangiocarcinoma, FGFR2 Fusion, FGFR2 Gene Mutation, FGFR1 Alteration, FGFR3 Alteration

In brief

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

Key facts

Study ID

NCT04919642

Run by

TransThera Sciences (Nanjing), Inc.

People needed

55

Starts

2021-12-07

Expected to finish

2024-02-28

Last updated by the study team

2024-06-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ≥ 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

You may not qualify if…

• 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.

Where it is running

• Providence Cancer Center — Anchorage, Alaska, United States
• City of Hope — Duarte, California, United States
• University of California, Los Angeles, School of Medicine — Santa Monica, California, United States
• USO Oncology Network- Rocky Mountain Cancer Centers — Denver, Colorado, United States
• Mount Sinai Medical Center — Miami Beach, Florida, United States
• University of Chicago Medical Center - Duchossis Center for Advanced Medicine — Chicago, Illinois, United States
• University of Maryland - Marlene and Stewart Greenebaum Cancer Center — Baltimore, Maryland, United States
• University of Michigan Comprehensive Cancer Center — Ann Arbor, Michigan, United States
• Henry Ford Health Center — Detroit, Michigan, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Comprehensive Cancer Center of Nevada — Las Vegas, Nevada, United States
• Summit Medical Group - Florham Park Campus — Florham Park, New Jersey, United States
• Roswell Park Comprehensive Cancer Center — Buffalo, New York, United States
• Ruttenberg Treatment Center - Mount Sinai — New York, New York, United States
• USOR Oncology Network- New York Oncology — New York, New York, United States
• Stony Brook University - Long Island Cancer Center — Stony Brook, New York, United States
• University of Cincinnati Cancer Institute — Cincinnati, Ohio, United States
• University Hospitals Seidman Cancer Center — Cleveland, Ohio, United States
• USO Oncology Network-Northwest Cancer Specialists, P.C. — Portland, Oregon, United States
• Medical College of South Carolina — Charleston, South Carolina, United States
• The University of Tennessee Medical Center — Knoxville, Tennessee, United States
• Sarah Cannon Research Institute at Tennessee Oncology — Nashville, Tennessee, United States
• Methodist Dallas Medical Center — Dallas, Texas, United States
• Parkland Health & Hospital System — Dallas, Texas, United States
• University of Texas Southwestern Harold C. Simmons Comprehensive Cancer Center — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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