Neoplasms

All Conditions

Rare Diseases

Cholangiocarcinoma

Adenocarcinoma

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Bile Duct Cancer

Crouzon Syndrome

Jackson-Weiss Syndrome

Pfeiffer Syndrome

FGFR2 fusions who have failed at least one previous treatment with an FGFR inhibitor

FGFR2 fusions who have previously responded on at least one previous treatment with an FGFR inhibitor and discontinued due to disease progression

Other FGFR alterations, including FGFR2 mutations and FGFR1/3 alterations, including fusions

Negative for FGFR alterations (FGFR wild-type)

TT-00420 tablet, administered orally once daily

TT-00420

Milind Javle, MD

This study is an open-label, multicenter study to evaluate the efficacy and safety of TT-00420 tablet in adult patients with advanced cholangiocarcinoma.

This is a Phase II, open-label study to evaluate the efficacy and safety of TT00420 in patients with advanced/metastatic and surgically unresectable cholangiocarcinoma (CCA) with 1) FGFR 2 fusions who failed prior FGFR inhibitor treatment, 2) FGFR2 fusions who responded on prior FGFR inhibitor treatment, 3) with other FGFR alterations, or 4) whose tumors do not contain a detectable FGFR alteration.

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

A Phase II, Open Label, Multicenter Study to Evaluate the Efficacy and Safety of TT-00420 (Tinengotinib) Tablet in Adult Patients With Advanced Cholangiocarcinoma

Evaluation of biomarkers, including but not limited to, FGFR mutation status

The proportion of subjects who achieved a complete response (CR) or a partial response (PR) based on RECIST version 1.1.

TransThera Sciences (Nanjing), Inc.

Symptoms and General Pathology

Carcinoma, Transitional Cell

Neoplasm Metastasis

Transitional Cell Carcinoma

Intrahepatic Cholangiocarcinoma

Dose escalation of KIN-3248 in patients with solid tumors

Dose expansion evaluating the recommended dose and schedule of KIN-3248 identified from Part A

KIN-3248 will be administered orally once daily in 28-day cycles

KIN-3248

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of KIN-3248, an oral small molecule FGFR inhibitor, in adults with advanced tumors harboring FGFR2 and/or FGFR3 gene alterations.

This is a two-part, open label, multi-center, dose escalation and dose expansion study in participants with advanced tumors harboring FGFR2 and/or FGFR3 gene alterations.

Part A (dose escalation) is aimed at evaluating the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of KIN-3248, and determining the maximum tolerated dose (MTD) of daily dosing of KIN-3248.

Part B (dose expansion) may open once either the MTD and/or a biologically active dose of KIN-3248 is identified. Part B is aimed at evaluating the safety and efficacy of KIN-3248 at the recommended dose and schedule in participants with cancers harboring FGFR2 and/or FGFR3 gene alterations, including intrahepatic cholangiocarcinoma (ICC), urothelial cancer (UC), and other solid tumors.

A Study to Evaluate KIN-3248 in Participants With Advanced Tumors Harboring FGFR2 and//or FGFR3 Gene Alterations

A Phase 1/1b, Open-label, Multicenter Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Anti-tumor Activity of KIN-3248 in Participants With Advanced Tumors Harboring FGFR2 and/or FGFR3 Gene Alterations

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study to Evaluate the Efficacy and Safety of TT-00420 (Tinengotinib) in Cholangiocarcinoma	NCT04919642	Cholangiocarcin... FGFR2 Fusion FGFR2 Gene Muta... FGFR1 Alteratio... FGFR3 Alteratio...	TT-00420	18 Years -	TransThera Sciences (Nanjing), Inc.
A Study to Evaluate KIN-3248 in Participants With Advanced Tumors Harboring FGFR2 and//or FGFR3 Gene Alterations	NCT05242822	Solid Tumor, Ad... Intrahepatic Ch... Urothelial Carc...	KIN-3248	18 Years -	Kinnate Biopharma
A Study to Evaluate KIN-3248 in Participants With Advanced Tumors Harboring FGFR2 and//or FGFR3 Gene Alterations	NCT05242822	Solid Tumor, Ad... Intrahepatic Ch... Urothelial Carc...	KIN-3248	18 Years -	Kinnate Biopharma
A Study to Evaluate KIN-3248 in Participants With Advanced Tumors Harboring FGFR2 and//or FGFR3 Gene Alterations	NCT05242822	Solid Tumor, Ad... Intrahepatic Ch... Urothelial Carc...	KIN-3248	18 Years -	Kinnate Biopharma

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