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Cholangiocarcinoma MetastaticPhase 2NCT06057571

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

A Phase 2 study testing TT-00420 (tinengotinib) in people with Cholangiocarcinoma Metastatic, run by TransThera Sciences (Nanjing), Inc. at 29 sites in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cholangiocarcinoma Metastatic
What is being tested?
TT-00420 (tinengotinib)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
29 sitesChina
Study dates
17 Nov 2023to 31 Dec 2025
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • ≥ 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.
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  • 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.

Who cannot join

  • 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).
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  • 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.
  • The investigator determines that he or she is not eligible for study participation for any clinical or laboratory abnormalities, or any reason that could confuse the study results, interfere with participants' safe participation and compliance with the trial procedure.

Trial locations and contacts

29 sites in 1 country.

29 sites in 1 country

China29 sites

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality

  • Beijing Cancer Hospital

    Beijing, 100142

  • Beijing Cancer Hospital

    Beijing

  • Beijing Tsinghua Changgeng Hospital

    Beijing

  • Jilin Cancer Hospital

    Changchun, Jilin

  • Hunan Cancer Hospital

    Changsha, Hunan

  • Hunan Provincial People's Hospital

    Changsha, Hunan

  • Sichuan Cancer Hospital

    Chengdu, Sichuan

  • Fujian Cancer Hospital

    Fuzhou, Fujian

  • Zhujiang Hospital of Southern Medical University

    Guangzhou, Guangdong

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang

  • Anhui Provincial Hospital

    Hefei, Anhui

  • Central Hospital Affiliated to Shangdong First Medical University

    Jinan, Shandong

  • Shandong Cancer Hospital

    Jinan, Shandong

  • Yunnan Cancer Hospital

    Kunming, Yunnan

  • Nanjing Drum Tower Hospital

    Nanjing, Jiangsu

  • Eastern Hepatobiliary Surgery Hospital

    Shanghai, Shanghai Municipality

  • Fudan University Shanghai Cancer Hospital

    Shanghai

  • Zhongshan Hospital

    Shanghai

  • Liaoning Cancer Hospital

    Shenyang, Liaoning

  • Shenzhen Qianhai Shekou Free Trade Zone hospital

    Shenzhen, Guangdong

  • The Fourth Hospital of Hebei Medical University

    Shijiazhuang, Hebei

  • Shanxi Cancer Hospital

    Taiyuan, Shanxi

  • Tianjin medical university cancer institute & hospital

    Tianjin

  • Hubei Cancer Hospital

    Wuhan, Hubei

  • Zhongnan hospital of Wuhan University

    Wuhan, Hubei

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 210000

  • Henan Cancer Hospital

    Zhengzhou, Henan

Other trials in China

About this study

Official title: 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

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.

Read the detailed description

Approximately 50 subjects will be enrolled. Eligible subjects will receive tinengotinib 10 mg QD orally as the initial dose level in 21-day cycles until confirmed disease progression, intolerable toxicity, death, or withdrawal of consent.

Being tested
TT-00420 (tinengotinib)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TT-00420 (tinengotinib)Drug

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

Study groups in NCT06057571
Study groupRoleWhat they receive
TT-00420 (tinengotinib) Tablet MonotherapyExperimentalTT-00420 (tinengotinib) tablets will be administered once daily in 21-day cycles with initial dosage of 10 mg QD.
Receives: Drug: TT-00420 (tinengotinib)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Through study completion, an average of 1 year

Secondary outcomes (6)

  1. Progression-free survival (PFS)

    From first study drug administration until the date of first documented progression or date of death from any cause, whichever came first

    Measured: Through study completion, an average of 1 year

  2. Overall Survival (OS)

    From first study drug administration until the date of death from any cause

    Measured: Through study completion, an average of 1 year

  3. ORR by Investigator

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

    Measured: Through study completion, an average of 1 year

  4. Disease control rate (DCR)

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

    Measured: Through study completion, an average of 1 year

  5. Duration of response (DOR)

    Duration of response for CR or PR based on RECIST version 1.1.

    Measured: Through study completion, an average of 1 year

  6. Incidence, duration, and severity of adverse events (AEs)

    As assessed per Common Terminology Criteria for Adverse Events (CTCAE) v5.0 (or the most current version).

    Measured: Up to 28 days from study discontinuation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Sep 2023
  2. Study start17 Nov 2023
  3. Primary completion27 Jul 2025
  4. Study completion31 Dec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06057571
Sponsor's protocol ID
TT00420CN08
Status last verified
Aug 2025
First submitted
5 Sep 2023
Last updated
21 Aug 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing TT-00420 (tinengotinib) in people with Cholangiocarcinoma Metastatic, run by TransThera Sciences (Nanjing), Inc. at 29 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 21 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 29 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) by BICR (time frame: Through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06057571.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2025.

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