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

NCT06057571 | Active Not Recruiting Phase 2 DMC

• 1 other identifier: TT00420CN08
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 29

Brief Summary

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.

Conditions

Cholangiocarcinoma Metastatic

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR) by BICR

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

  Through study completion, an average of 1 year

Secondary Outcomes (6)

• Progression-free survival (PFS)

  Through study completion, an average of 1 year

• Overall Survival (OS)

  Through study completion, an average of 1 year

• ORR by Investigator

  Through study completion, an average of 1 year

• Disease control rate (DCR)

  Through study completion, an average of 1 year

• Duration of response (DOR)

  Through study completion, an average of 1 year

Study Arms (1)

TT-00420 (tinengotinib) Tablet Monotherapy

EXPERIMENTAL

TT-00420 (tinengotinib) tablets will be administered once daily in 21-day cycles with initial dosage of 10 mg QD.

Drug: TT-00420 (tinengotinib)

Interventions

TT-00420 (tinengotinib) DRUG

TT-00420 (tinengotinib) tablet will be administered orally once daily per protocol defined schedule.

TT-00420 (tinengotinib) Tablet Monotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 18 years of age at the time of signing the informed consent form (ICF).
• Histologically or cytologically confirmed CCA/adenocarcinoma of biliary origin with radiological evidence of unresectable or metastatic disease.
• Subjects must have received one or two lines of prior systemic chemotherapy.
• Documentation of FGFR2 gene alteration and must have failed to prior treatment of exactly one FGFR inhibitor.
• At least one measurable lesion as defined by RECIST V1.1 criteria for solid tumors.
• ECOG≤ 1.
• Adequate organ and bone marrow function(without receiving any hematopoietic growth factor, blood or platelet therapy within 14 days before the first dose).
• Must agree to take sufficient contraceptive methods to avoid pregnancy during the study and until at least 3 months after ceasing study treatment.
• Able to sign informed consent and comply with the protocol.

You may not qualify if:

• Subjects with concomitant brain or central nervous system (CNS) metastases and imaging or clinically confirmed progression within 28 days prior to the start of treatment. Brain or central nervous system metastases that not treated with corticosteroids and remain stable within 14 days prior to screening are eligible for enrollment.
• Subjects with a known concurrent malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, carcinoma in situ of the cervix, or other noninvasive or indolent malignancy, including those that have previously undergone potentially curative therapy.
• Subjects who have received prior systemic therapy or investigational study drug ≤ 5 half-lives or 14 days, whichever is shorter, prior to starting the study drug or who have not recovered (grade ≤ 1 or at pretreatment baseline except tolerable grade 2 alopecia, fatigue/asthenia, and neuropathy due to trauma) from adverse events (AEs) of prior therapy.
• Concurrent anticancer therapy including chemo-, immune-, or radiotherapy. Hormone therapy may be allowed with Sponsor approval.
• Subjects who have received wide field radiotherapy ≤ 4 weeks or limited field radiation for palliation ≤ 2 weeks prior to starting the study drug or who have not recovered from AEs of prior therapy.
• Subjects who have underwent major surgery or have not recovered from adverse events of surgery within the 4 weeks prior to initiation of the investigational drug (grade ≤ 1 or at pretreatment baseline except tolerable grade 2 alopecia, fatigue/asthenia, and neuropathy due to trauma).
• Impaired cardiac function or significant diseases.
• Subjects who have received stable doses of antihypertensive drugs for at least 1 week with uncontrolled hypertension under at screening period (defined as blood pressure of ≥ 150 mm Hg systolic and/or ≥ 90 mm Hg diastolic despite adequate treatment with antihypertensive medications at screening).
• Subjects who have severe gastrointestinal disease or gastrointestinal dysfunction that may lead to absorption, metabolism or excretion of the study drug, enrollment eligibility will be based on the investigator's judgment (including but not limited to total gastrotomy, short bowel syndrome).
• Subjects who have bleeding disorders or thrombotic disorders or therapeutic anticoagulant therapy requiring INR monitoring.
• Subjects who have received a strong CYP3A inhibitor and inducer before starting the study drug, within an interval of ≤ 2 weeks or 5 half-lives (whichever is shorter); (except topical ketoconazole).
• Tested positive for the human immunodeficiency virus (HIV).
• Subjects who have an active HBV infection.
• Subjects who are pregnant or breastfeeding.
• Subjects who are unable to swallow or tolerate oral medication.

Sponsors & Collaborators

• TransThera Sciences (Nanjing), Inc.: lead

Study Sites (29)

Anhui Provincial Hospital

Hefei, Anhui, China

Location

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Location

Fujian Cancer Hospital

Fuzhou, Fujian, China

Location

Zhujiang Hospital of Southern Medical University

Guangzhou, Guangdong, China

Location

Shenzhen Qianhai Shekou Free Trade Zone hospital

Shenzhen, Guangdong, China

Location

The Fourth Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Location

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China

Location

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 210000, China

Location

Henan Cancer Hospital

Zhengzhou, Henan, China

Location

Hubei Cancer Hospital

Wuhan, Hubei, China

Location

Zhongnan hospital of Wuhan University

Wuhan, Hubei, China

Location

Hunan Cancer Hospital

Changsha, Hunan, China

Location

Hunan Provincial People's Hospital

Changsha, Hunan, China

Location

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, China

Location

Jilin Cancer Hospital

Changchun, Jilin, China

Location

Liaoning Cancer Hospital

Shenyang, Liaoning, China

Location

Central Hospital Affiliated to Shangdong First Medical University

Jinan, Shandong, China

Location

Shandong Cancer Hospital

Jinan, Shandong, China

Location

Eastern Hepatobiliary Surgery Hospital

Shanghai, Shanghai Municipality, China

Location

Shanxi Cancer Hospital

Taiyuan, Shanxi, China

Location

Sichuan Cancer Hospital

Chengdu, Sichuan, China

Location

Yunnan Cancer Hospital

Kunming, Yunnan, China

Location

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Location

Beijing Cancer Hospital

Beijing, 100142, China

Location

Beijing Cancer Hospital

Beijing, China

Location

Beijing Tsinghua Changgeng Hospital

Beijing, China

Location

Fudan University Shanghai Cancer Hospital

Shanghai, China

Location

Zhongshan Hospital

Shanghai, China

Location

Tianjin medical university cancer institute & hospital

Tianjin, China

Location

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2023
• First Posted: September 28, 2023
• Study Start: November 17, 2023
• Primary Completion: July 27, 2025
• Study Completion: December 31, 2025
• Last Updated: August 21, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (29)