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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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
. 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.
. 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