Study of TT-00420 (Tinengotinib) Tablet as Monotherapy and Combination Therapy in Patients With A… (NCT04742959) | Clinical Trial Compass
CompletedPhase 1/2
Study of TT-00420 (Tinengotinib) Tablet as Monotherapy and Combination Therapy in Patients With Advanced Solid Tumors
United States203 participantsStarted 2021-03-14
Plain-language summary
This is a Phase Ib/II, multicenter, open-label study to evaluate the safety and preliminary efficacy of TT-00420 tablet, as monotherapy or in combination regimens, in patients with advanced solid tumors.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. ≥ 18 years of age
✓. Histopathological or cytologically documented locally advanced or metastatic solid tumors who have no available standard therapeutic treatment options
✓. At least one measurable lesion as defined by RECIST V1.1 criteria for solid tumors
✓. 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:
✓. 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 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 any hematologic malignancy, including leukemia (any form), lymphoma, and multiple myeloma
✕. Patients with a history of primary central nervous system tumors or carcinomatous meningitis.
What they're measuring
1
Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment
Timeframe: Up to 30 days from study discontinuation
✕. Patients with the following mood disorders as judged by the Investigator or a psychiatrist:
✕. Impaired cardiac function or significant diseases, including but not limited to any of the following:
✕. Patients with:
✕. Other concurrent severe and/or uncontrolled concomitant medical conditions (e.g., uncontrolled hypertension, uncontrolled hypertriglyceridemia, or active or uncontrolled infection) that could cause unacceptable safety risks or compromise compliance with the protocol