To Evaluate Efficacy and Safety of TT-00420 (Tinengotinib) as Monotherapy and Combination Therapy in Patients With Advanced Solid Tumors
NCT05253053 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 84
Last updated 2025-06-12
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).
Conditions
- Advanced Solid Tumor
- Cholangiocarcinoma
- Biliary Tract Cancer
- HER2-negative Breast Cancer
- Triple Negative Breast Cancer
- Small-cell Lung Cancer
- Bladder Cancer
- Prostate Cancer
- Thyroid Cancer
- Gastric Cancer
- Gallbladder Cancer
Interventions
- DRUG
-
TT-00420
TT-00420 tablet will be administered orally once daily per protocol defined schedule.
- DRUG
-
Combination Product: Atezolizumab
Atezolizumab would be administered via infusion on Day 1 of 21-day cycle
- DRUG
-
Combination Product: Nab-Paclitaxel
Nab-Paclitaxel would be administered via infusion on Day 1 and 8 of 21-day cycle
Sponsors & Collaborators
-
TransThera Sciences (Nanjing), Inc.
lead INDUSTRY
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-04-13
- Primary Completion
- 2024-08-31
- Completion
- 2024-08-31
Countries
- China
Study Locations
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