New pill takes on bile duct cancer: phase 3 trial launches
NCT ID NCT07328919
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This Phase 3 trial tests a new daily pill, TT-00420, against standard chemotherapy in 138 adults with advanced bile duct cancer that has a specific genetic change (FGFR2 fusion or mutation) and has worsened after first treatment. The study compares how long the cancer stays under control and overall survival. It is open-label, meaning everyone knows which treatment they receive.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- TT-00420 (tinengotinib) tablets
- What this could lead to
- If successful, this could provide a new targeted treatment option for people with a specific type of advanced bile duct cancer that has stopped responding to initial chemotherapy.
- What could go wrong
- This is an early-stage Phase 3 trial with only 138 participants, so results may not apply to all patients. The drug may not prove more effective than chemotherapy and could have side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
-
About 138 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
-
Jan 2026
An estimate. Start dates often move.
- Expected to finish
-
Dec 2030
An estimate. End dates often move.
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. ≥ 18 years of age at the time of signing the informed consent form (ICF). 2. Histologically or cytologically confirmed intrahepatic cholangiocarcinoma. 3. Subjects diagnosed with stage III or IV intrahepatic cholangiocarcinoma according to the American Joint Committee on Cancer (AJCC) 8th Edition (2018) staging system, and assessed by the investigator as not eligible for curative surgical resection. 4. Subjects who have experienced recurrence or progression after receiving only one prior line of systemic chemotherapy combined with immunotherapy (PD-1/PD-L1 inhibitor), with or without targeted therapy. Sequential immunotherapy following the completion of chemotherapy cycles is also considered part of the first-line combined regimen. First-line systemic chemotherapy is defined as gemcitabine/capecitabine with or without a platinum-based agent. Note: Recurrence within 6 months after completion of adjuvant or neoadjuvant therapy will be considered as a line of systemic therapy. Local treatments do not count as systemic therapy. 5. The presence of FGFR2 gene fusion/rearrangement or mutation must be confirmed by detection using tumor tissue samples provided by the patient and analyzed by a central laboratory. 6. At least one radiographically measurable lesion must be present according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. 7. ECOG ≤ 1. 8. Subjects must have adequate organ and bone marrow function. Exclusion Criteria: 1. Subjects with a history of prior treatment with TT-00420 tablets. 2. Subjects with a known severe allergic reaction to any agent in the study and for whom no alternative study treatment is available. 3. Subjects receiving corticosteroid therapy for CNS metastases are also ineligible. 4. Concurrent active malignancy requiring active treatment. Malignancies diagnosed \>5 years ago without the need for treatment, as well as cured localized tumors such as basal cell carcinoma of the skin, carcinoma in situ of the cervix, or papillary thyroid carcinoma, are allowed. 5. Administration of other anti-tumor drugs prior to randomization with an interval of ≤ 5 half-lives or 14 days (whichever is shorter), or failure to recover from adverse events of prior therapies (except for adverse events of ≤ Grade 1, or ≤ Grade 2 events judged by the investigator as not constituting a safety risk). 6. Prior radiation therapy (large-field radiotherapy within 4 weeks, or local palliative radiotherapy within 2 weeks, before randomization), or failure to recover from related adverse events, is excluded. However, initiation of the investigational drug during the washout period is permitted with sponsor approval, if the investigator believes it is in the subject's best interest based on a favorable benefit-risk assessment. 7. Subjects who have undergone major surgery within 4 weeks prior to randomization, or who have not recovered from related adverse events (with the exception of ≤ Grade 1 events or non-risk Grade 2 events per investigator's judgment), are excluded. 8. Subjects with uncontrolled hypertension (defined as blood pressure of ≥ 150 mm Hg systolic and/or ≥ 90 mm Hg diastolic despite adequate treatment with antihypertensive medications at screening).
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Advanced cholangiocarcinoma are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
20 sites. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Anhui Provincial Hospital
Hefei, Anhui, China
-
Beijing Cancer Hospital
Beijing, China
-
Beijing Tsinghua Changgung Hospital
Beijing, China
-
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, China
-
Eastern Hepatobiliary Surgery Hospital
Shanghai, China
-
Fudan University Shanghai Cancer Hospital
Shanghai, China
-
Fujian Cancer Hospital
Fuzhou, Fujian, China
-
Hunan Cancer Hospital
Changsha, Hunan, China
-
Jinan Central Hospital
Jinan, Shandong, China
-
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China
-
Peking Union Medical College Hospital
Beijing, China
-
Shandong Cancer Hospital
Jinan, Shandong, China
-
Sichuan Cancer Hospital
Chengdu, Sichuan, China
-
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
-
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
-
West China Hospital of Sichuan University
Chengdu, Sichuan, China
-
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
-
Zhongnan hospital of Wuhan University
Wuhan, Hubei, China
-
Zhongshan Hospital, Fudan University
Shanghai, China
-
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a targeted pill shrink hard-to-treat bile duct cancers?
- Can AI be a second pair of eyes for liver cancer detection?
- Spirulina's secret protein may shield the liver during surgery
- New drug cocktail aims to outsmart untreatable bile duct cancer
- AI could spot liver cancer types and predict survival without needle biopsy
- New drug cocktails aim to stop bile duct cancer return after surgery