Study of TT-00420 (Tinengotinib) Tablet as Monotherapy and Combination Therapy in Patients With Advanced Solid Tumors
NCT04742959 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 203
Last updated 2024-04-26
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.
Conditions
- Advanced Solid Tumor
- Cholangiocarcinoma
- HER2-negative Breast Cancer
- Triple Negative Breast Cancer
- Bladder Cancer
- Small-cell Lung Cancer
- Prostate Cancer
- Thyroid Cancer
- Sarcoma
- Gastric Cancer
- Gallbladder Cancer
Interventions
- DRUG
-
TT-00420
TT-00420 tablet will be administered orally once daily per protocol defined schedule.
- COMBINATION_PRODUCT
-
Nab-Paclitaxel
Nab-Paclitaxel would be administered via infusion on Day 1,8, and 15 of 28-day cycle
Sponsors & Collaborators
-
TransThera Sciences (Nanjing), Inc.
lead INDUSTRY
Principal Investigators
-
Sarina A. Piha-Paul, MD · M.D. Anderson Cancer Center
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-03-14
- Primary Completion
- 2024-02-20
- Completion
- 2024-02-20
- FDA Drug
- Yes
Countries
- United States
Study Locations
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