To Evaluate Efficacy and Safety of TT-00420 (Tinengotinib) as Monotherapy and Combination Therapy… (NCT05253053) | Clinical Trial Compass
CompletedPhase 1/2
To Evaluate Efficacy and Safety of TT-00420 (Tinengotinib) as Monotherapy and Combination Therapy in Patients With Advanced Solid Tumors
China84 participantsStarted 2022-04-13
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 (solid tumor, BTC and TNBC).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. ≥ 18 years of age
✓. Arm A：Histopathological or cytologically documented locally advanced or metastatic and solid tumors（including but not limited to advanced cholangiocarcinoma, small cell lung cancer, HER2-negative breast cancer including TNBC, bladder cancer, prostate cancer, thyroid cancer, gastric cancer, gallbladder cancer and other advanced solid tumors.
✓. Received all currently available standard treatments (unless the treatment is contraindicated, intolerable, or unavailable for any reason)
✓. At least one measurable lesion as defined by RECIST V1.1 criteria for solid tumors
✓. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
✓. 6\. Adequate organ and bone marrow function(without receiving any hematopoietic growth factor, blood or platelet therapy within 1 week before the first dose.
✓. 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
What they're measuring
1
Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment
✕. Impaired cardiac function or significant diseases, including but not limited to any of the following:
✕. Patients who are currently receiving treatment with medication that has known risk to prolong the QT interval or induce Torsades de Pointes, and the treatment cannot either be discontinued or switched to a different medication prior to starting study drug.
✕. Patients with impairment of gastrointestinal (GI) function, or GI disease that may significantly alter the absorption of TT-00420
✕. 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