TT-00420

DRUG4 trials

Conditions

Advanced Solid TumorAdvanced Solid TumorsBiliary Tract CancerBladder CancerCholangiocarcinomaFGFR1 AlterationFGFR2 FusionFGFR2 Gene Mutation

Phase 1

Safety of TT-00420 (Tinengotinib) Monotherapy in Patients With Advanced Solid Tumors and Triple Negative Breast Cancer

CompletedNCT03654547

TransThera Sciences (Nanjing), Inc.Advanced Solid Tumors, Triple Negative Breast Cancer

Start: 2019-01-08End: 2024-02-28Updated: 2025-07-24

Study of TT-00420 (Tinengotinib) Tablet as Monotherapy and Combination Therapy in Patients With Advanced Solid Tumors

CompletedNCT04742959

TransThera Sciences (Nanjing), Inc.Advanced Solid Tumor, Bladder Cancer, Cholangiocarcinoma +8

Start: 2021-03-14End: 2024-02-20Updated: 2024-04-26

To Evaluate Efficacy and Safety of TT-00420 (Tinengotinib) as Monotherapy and Combination Therapy in Patients With Advanced Solid Tumors

CompletedNCT05253053

TransThera Sciences (Nanjing), Inc.Advanced Solid Tumor, Biliary Tract Cancer, Bladder Cancer +8

Start: 2022-04-13End: 2024-08-31Updated: 2025-06-12

Phase 2

Study to Evaluate the Efficacy and Safety of TT-00420 (Tinengotinib) in Cholangiocarcinoma

CompletedNCT04919642

TransThera Sciences (Nanjing), Inc.Cholangiocarcinoma, FGFR1 Alteration, FGFR2 Fusion +2

Start: 2021-12-07End: 2024-02-28Updated: 2024-06-25

2026-07-23

The multi-kinase inhibitor tinengotinib as monotherapy or combined with atezolizumab in advanced solid tumors: a phase Ib/II trial

Nature Communications2026-05-11

Abstract PS4-06-14: Tinengotinib in advanced or metastatic HR+/HER2- and TNBC: efficacy and biomarker correlative analysis from a phase Ib/II study

Clinical Cancer Research2026-02-17

Phase II study of tinengotinib in advanced cholangiocarcinoma: Analysis of molecular response and resistance mechanisms.

Journal of Clinical Oncology2026-01-10

Tinengotinib for adults with advanced or metastatic cholangiocarcinoma: a multicentre, open-label, phase 2 trial.

2025-12-02

Use of an in-silico clinical trial intelligence solution to predict outcomes of tinengotinib, a potent multi-kinase small molecule FGFR inhibitor in patients with cholangiocarcinoma, based on the molecular matching score.

Journal of Clinical Oncology2025-05-28

Abstract 4352: Safety and pharmacokinetics of tinengotinib monotherapy in different doses and dosing schedules in advanced solid tumors

Cancer Research2025-04-211 citations

Abstract 825: Correlation of clinical and biomarker data in FGFR inhibitor failed metastatic cholangiocarcinoma patients with tumor response to tinengotinib

Cancer Research2025-04-21

Tinengotinib in patients with advanced, metastatic cholangiocarcinoma: Overall survival results and biomarker correlative analysis from a phase 2 clinical trial.

Journal of Clinical Oncology2025-01-271 citations

Abstract RF01-07: The efficacy and safety of tinengotinib in patients with advanced or metastatic HR+/HER2- breast cancer or TNBC

Cancer Research2024-05-02

Abstract LB162: Tinengotinib in patients with advanced solid tumors harboring actionable FGFR1-3 mutations

Cancer Research2024-04-05

The efficacy and safety of tinengotinib in patients with heavily pretreated metastatic castration-resistant prostate cancer (mCRPC).

Journal of Clinical Oncology2024-02-01

Efficacy and safety results of FGFR1-3 inhibitor, tinengotinib, as monotherapy in patients with advanced, metastatic cholangiocarcinoma: Results from phase II clinical trial.

Journal of Clinical Oncology2024-01-2013 citations

First-308: Phase III study of tinengotinib versus physician's choice in patients with FGFR-altered, chemotherapy- and FGFR inhibitor–refractory/relapsed cholangiocarcinoma.

Journal of Clinical Oncology2024-01-205 citations

Tinengotinib (TT-00420) in combination with atezolizumab in Chinese patients (pts) with biliary tract carcinoma (BTC): Preliminary efficacy and safety results from a phase Ib/II study.

Journal of Clinical Oncology2024-01-201 citations

Preliminary safety and efficacy of tinengotinib tablets as monotherapy and combination therapy in advanced solid tumors: A phase Ib/II clinical trial.

Journal of Clinical Oncology2023-06-0111 citations

Phase II study of FGFR1-3 inhibitor tinengotinib as monotherapy in patients with advanced or metastatic cholangiocarcinoma: Interim analysis.

Journal of Clinical Oncology2023-01-2415 citations

Tinengotinib (TT-00420), a Novel Spectrum-Selective Small-Molecule Kinase Inhibitor, Is Highly Active Against Triple-Negative Breast Cancer

Molecular Cancer Therapeutics2022-10-1222 citations

First-in-human, phase I study of TT-00420, a multiple kinase inhibitor, as a single agent in advanced solid tumors.

Journal of Clinical Oncology2022-06-015 citations

Phase I study of TT-00420, a multiple kinase inhibitor, as a single agent in advanced solid tumors.

Journal of Clinical Oncology2021-05-208 citations

2 more papers not shown

TT-00420

Sponsors

Conditions

Phase 1

Phase 2

Related Papers