Clinical Trial: NCT05253053
To Evaluate Efficacy and Safety of TT-00420 (Tinengotinib) as Monotherapy and Combination Therapy in Patients With Advanced Solid Tumors
Status:
COMPLETEDPhase:
Phase 1| Lead Sponsor: | TransThera Sciences (Nanjing), Inc. |
| Information Provided By: | TransThera Sciences (Nanjing), Inc. |
| Last Update Posted: | 2025-06-12 |
Study Overview
Brief 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).
Official Title
A Phase Ib/II Study of TT-00420 Tablet, as Monotherapy or in Combination Regimens, to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy in Patients With Advanced Solid Tumor
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
Intervention / Treatment
- Drug: TT-00420
- Drug: Combination Product: Atezolizumab
- Drug: Combination Product: Nab-Paclitaxel
Other Study ID Numbers
- TT00420CN04
Start Date (Actual)
2022-04-13
Primary Completion Date (Actual)
2024-08-31
Study Completion Date (Actual)
2024-08-31
Enrollment (Actual)
84
Study Type
Interventional
Phase
Phase 1, Phase 2
| Lead Sponsor: | TransThera Sciences (Nanjing), Inc. |
| Information Provided By: | TransThera Sciences (Nanjing), Inc. |
| Last Update Posted: | 2025-06-12 |
Study Overview
Brief 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).
Official Title
A Phase Ib/II Study of TT-00420 Tablet, as Monotherapy or in Combination Regimens, to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy in Patients With Advanced Solid Tumor
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
Intervention / Treatment
- Drug: TT-00420
- Drug: Combination Product: Atezolizumab
- Drug: Combination Product: Nab-Paclitaxel
Other Study ID Numbers
- TT00420CN04
Start Date (Actual)
2022-04-13
Primary Completion Date (Actual)
2024-08-31
Study Completion Date (Actual)
2024-08-31
Enrollment (Actual)
84
Study Type
Interventional
Phase
Phase 1, Phase 2