Safety of TT-00420 (Tinengotinib) Monotherapy in Patients With Advanced Solid Tumors and Triple Negative Breast Cancer

Completed · Phase 1

Conditions studied: Advanced Solid Tumors, Triple Negative Breast Cancer

In brief

This is a first-in-human, phase I clinical research study with TT-00420, an investigational, oral, multi-target, dual mechanism kinase inhibitor targeting both mitosis and tumor micro-environment, for the treatment of triple negative breast cancer (TNBC) and other advanced solid tumors. The study consists of a dose escalation part followed by a MTD expansion part.

Key facts

Study ID

NCT03654547

Run by

TransThera Sciences (Nanjing), Inc.

People needed

48

Starts

2019-01-08

Expected to finish

2024-02-28

Last updated by the study team

2025-07-24

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Aged 18 years to 75 years at the time of provision of informed consent
• Dose Escalation Cohorts: Histopathological or cytologically documented locally advanced or metastatic solid tumors who have no available standard therapeutic treatment options Dose Expansion Cohorts: Histopathological or cytologically documented locally advanced or metastatic TNBC or SATs
• TNBC Dose Expansion Cohort:
• Histologically proven invasive breast carcinoma with triple negative receptor status per institutional standard and with confirmed negative for ER and PR by IHC (<10% positive tumor nuclei)
• relapsed/refractory to at least one line of systemic chemotherapy
• At least one measurable lesion as defined by RECIST V1.1 criteria for solid tumors
• 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) ≥ 9 g/dl
• Platelets (plt) ≥ 100 x 10\^9/L
• AST/SGOT and 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, or direct bilirubin < ULN for patients with total bilirubin levels >1.5 ULN
• Serum creatinine ≤ 1.5 x ULN or calculated 24-hour clearance ≥ 50 mL/min
• Negative pregnancy test within 72 hours before starting study treatment in all pre-menopausal women and women < 12 months after the onset of menopause
• Must agree to take sufficient contraceptive methods to avoid pregnancy during the study and until at least 6 months after ceasing study treatment
• Able to sign informed consent and to comply with the protocol

You may not qualify if…

• Women who are pregnant or lactating
• Women of child-bearing potential (WOCBP) who does not use adequate birth control
• Patients with any hematologic malignancy. This includes leukemia (any form), lymphoma, and multiple myeloma.
• Patients with
• a history of primary central nervous system tumors or
• carcinomatous meningitis Note: Patients with treated brain metastases that are off corticosteroid and have been clinically stable 28 days are eligible for enrollment
• Patients with the following mood disorders as judged by the Investigator or a psychiatrist, or as result of patient's mood assessment questionnaire:
• 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
• The psychiatric judgment, if available, overrules the mood assessment questionnaire result/investigator judgment
• Impaired cardiac function or clinically significant cardiac diseases, including but not limited to any of the following:
• LVEF < 45% as determined by MUGA scan or ECHO
• Congenital long QT syndrome
• QTc ≥ 450 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
• unresolved diarrhea ≥ CTCAE grade 2, or
• impairment of gastrointestinal (GI) function, or
• GI disease that may significantly alter the absorption of TT-00420 (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection).
• Other concurrent severe and/or uncontrolled concomitant medical conditions (e.g., uncontrolled hypertriglyceridemia [triglycerides > 500 mg/dL], 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 ≤ 4 weeks (6 weeks for nitrosourea or mitomycin-C) prior to starting study drug or who have not recovered from side effects of such therapy
• 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 side effects of such therapy
• Patients who have undergone major surgery ≤ 4 weeks prior to starting study drug or who have not recovered from side effects of such therapy
• Patients who have been treated with any hematopoietic colony-stimulating growth factors (e.g., G-CSF, GM-CSF) ≤ 2 weeks prior to starting study drug. Erythropoietin or darbepoetin therapy, if initiated before enrollment, may be continued

Where it is running

• MD Anderson Cancer Center — Houston, Texas, United States
• Cancer Hopital Chinese Academy of Medical Sciences — Beijing, Beijing Municipality, China

Full record on ClinicalTrials.gov

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