Clinical Trials

Multiple clinical trials across Phase 1 through Phase 3 evaluate the safety, pharmacokinetics, and therapeutic efficacy of tinengotinib as monotherapy and in combination regimens. Sponsored by organizations such as TransThera Sciences, Memorial Sloan Kettering Cancer Center, and Akeso, these active and completed studies encompass healthy subjects as well as refractory malignancies, including FGFR-altered cholangiocarcinoma, triple-negative breast cancer, hepatocellular carcinoma, and prostate cancer.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07328919 NOT_YET_RECRUITING
Intrahepatic Cholangiocarcinoma (Icc); Advanced Cholangiocarcinoma
TransThera Sciences (Nanjing), Inc.
 2026-01 PHASE3
NCT07498478 RECRUITING
Breast Cancer
TransThera Sciences (Nanjing), Inc.
 2026-03-17 PHASE2
NCT06457919 RECRUITING
Prostate Cancer
Memorial Sloan Kettering Cancer Center
 2024-06-04 PHASE1; PHASE2
NCT07052253 RECRUITING
Hepatocellular Carcinoma (HCC)
Akeso
 2025-07-18 PHASE2
NCT05948475 ACTIVE_NOT_RECRUITING
Cholangiocarcinoma
TransThera Sciences (Nanjing), Inc.
 2023-12-20 PHASE3
NCT06057571 ACTIVE_NOT_RECRUITING
Cholangiocarcinoma Metastatic
TransThera Sciences (Nanjing), Inc.
 2023-11-17 PHASE2
NCT04919642 COMPLETED
Cholangiocarcinoma; FGFR2 Fusion; FGFR2 Gene Mutation; FGFR1 Alteration; FGFR3 Alteration
TransThera Sciences (Nanjing), Inc.
 2021-12-07 PHASE2
NCT04919642 Completed
Cholangiocarcinoma|FGFR2 Fusion|FGFR2 Gene Mutation|FGFR1 Alteration|FGFR3 Alteration
TransThera Sciences (Nanjing) Inc.
 2021-12-07 Phase 2
NCT04705922 Completed
Healthy
TransThera Sciences (Nanjing) Inc.
 2020-12-29 Phase 1
NCT03654547 Active not recruiting
Advanced Solid Tumors|Triple Negative Breast Cancer
TransThera Sciences (Nanjing) Inc.
 2019-01-08 Phase 1

(data from https://clinicaltrials.gov, updated on 2026-01-09)

Check the Tinengotinib product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Tinengotinib acts as a potent multi-kinase inhibitor that targets Aurora kinases A and B as well as fibroblast growth factor receptors (FGFR1/2/3), vascular endothelial growth factor receptor 1 (VEGFR1), Janus kinases (JAK1/2), and colony-stimulating factor 1 receptor (CSF1R), thereby disrupting downstream mitotic signaling and oncogenic kinase cascades. This multi-pathway blockade suppresses tumor cell proliferation, survival, and microenvironmental angiogenesis, providing a targeted therapeutic rationale for treating refractory advanced solid tumors, including FGFR-altered cholangiocarcinoma and triple-negative breast cancer.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.