Who is sponsoring NCT06057571?

NCT06057571 is sponsored by TransThera Sciences (Nanjing), Inc..

What drugs are being tested in NCT06057571?

Interventions in NCT06057571: TT-00420 (tinengotinib).

What condition does NCT06057571 study?

NCT06057571 studies Cholangiocarcinoma Metastatic.

Is NCT06057571 still recruiting?

NCT06057571 is currently active, enrolled. Last updated 21 August 2025.

Last reviewed 2025-08-21 · How we verify

NCT06057571

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Study of TT-00420 (Tinengotinib) in Subjects With Cholangiocarcinoma Who Failed or Relapsed to Chemotherapy and FGFR Inhibitor

Active, enrolled Phase 2 Last updated 21 August 2025

What this trial tests

Phase 2 trial testing TT-00420 (tinengotinib) in Cholangiocarcinoma Metastatic in 50 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

17 November 2023

Primary endpoint
27 July 2025

31 December 2025

Quick facts

Lead sponsor	TransThera Sciences (Nanjing), Inc.
Phase	Phase 2
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	50
Start date	17 November 2023
Primary completion	27 July 2025
Estimated completion	31 December 2025
Sites	29 locations across China

Drugs / interventions tested

TT-00420 (tinengotinib) — full drug profile →

Conditions studied

Cholangiocarcinoma Metastatic — all drugs for Cholangiocarcinoma Metastatic →

Sponsor

TransThera Sciences (Nanjing), Inc. — full company profile →

Who can join

18 and older, any sex, with Cholangiocarcinoma Metastatic. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

A phase II, open-label, multicenter study to evaluate the efficacy and safety of oral TT-00420 (Tinengotinib) tablets in subjects with cholangiocarcinoma who failed or relapsed to prior treatment of chemotherapy and FGFR Inhibitor.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

Aurora kinases signaling in cancer: from molecular perception to targeted therapies.
Vats P, Saini C, Baweja B, Srivastava SK, et al · · 2025 · cited 6× · PMID 40533769 · DOI 10.1186/s12943-025-02353-3
Current and Future Therapeutic Targets for Directed Molecular Therapies in Cholangiocarcinoma.
Heumann P, Albert A, Gülow K, Tümen D, et al · · 2024 · cited 4× · PMID 38730642 · DOI 10.3390/cancers16091690
FGFR as a Predictive Marker for Targeted Therapy in Gastrointestinal Malignancies: A Systematic Review.
Seraji N, Berger I. · · 2025 · cited 2× · PMID 40205008 · DOI 10.1007/s12029-025-01214-y
Research on Targeted Therapy for Malignant Tumors of the Biliary Tract.
Yang Y, Zhong H, Zhang J, Wang P. · · 2026 · PMID 42146765 · DOI 10.2147/ott.s593457
Second-Line Treatment in cholangiocarcinoma - Current State of the Art and Future Perspectives.
Siwek M, Chmiel P, Grabowska H, Grąt M, et al · · 2025 · PMID 41102546 · DOI 10.1007/s11864-025-01365-x

Verify or expand the search:

Other trials of TT-00420 (tinengotinib)

Trials testing the same drug.

NCT07052253 — A Phase II Clinical Study of AK104/AK112 in Combination With TT-00420 Tablet for Advanced HCC. · Phase 2 · recruiting

Other recruiting trials for Cholangiocarcinoma Metastatic

Currently open trials in the same condition.

NCT05655949 — Y-90 With Durvalumab/Gem/Cis in Intrahepatic Cholangio · Phase 2 · recruiting
NCT05053555 — High Dose-Rate Brachytherapy for the Treatment of Both Primary and Secondary Unresectable Liver Malignancies · NA · recruiting

Other TransThera Sciences (Nanjing), Inc. trials

Trials by the same sponsor.

NCT07498478 — Efficacy and Safety of Tinengotinib Tablets Combined With Fulvestrant Injection in Patients With HR Positive and HER-2 N · Phase 2 · recruiting
NCT05683717 — A Phase 1 Study to Evaluate the Safety and Tolerability of TT-01488 in Patients With B-Cell Malignancies · Phase 1 · recruiting
NCT05253053 — To Evaluate Efficacy and Safety of TT-00420 (Tinengotinib) as Monotherapy and Combination Therapy in Patients With Advan · Phase 1, PHASE2 · completed
NCT04919642 — Study to Evaluate the Efficacy and Safety of TT-00420 (Tinengotinib) in Cholangiocarcinoma · Phase 2 · completed
NCT05355129 — A Phase 1 Study of TT-00920 in Healthy Subjects · Phase 1 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT06057571 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by TransThera Sciences (Nanjing), Inc.
Last refreshed: 21 August 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06057571.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing