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New treatment option for Advanced Intrahepatic Cholangiocarcinoma
Official title HMPL-453 Tartrate in Advanced Intrahepatic Cholangiocarcinoma
ClinicalTrials.gov ID: NCT04353375
What this study is testing
What is HMPL-453?
HMPL-453 is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for advanced intrahepatic cholangiocarcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this clinical trial is to evaluate in patients with advanced intrahepatic cholangiocarcinoma harboring FGFR2 fusion/rearrangement. The main questions it aims to answer are: To evaluate the objective response rate (ORR) of HMPL-453 tartrate in the treatment of patients with advanced intrahepatic cholangiocarcinoma (ICC) habouring fibroblast growth factor receptor (FGFR) 2 fusions/rearrangements after at least one line of systemic treatment failure or intolerance Participants will receive HMPL-453 tartrate 300 mg QD orally (for 14 consecutive days [Days 1 to 14] followed by 7 days off [Day 15 to 21], 21 days as a treatment cycle.]
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Have fully understood the study and voluntarily signed the ICF;
- Age ≥ 18 years;
- a. pathologically or cytologically confirmed advanced treatment failure solid tumor with standard patients (applicable to cohorts2 stage I); b...
- a. The patients have received at least one prior systemic treatment regimen for advanced ICC and has intolerable PD or toxicity(Cohort1-3); b...
- Measurable lesion according to RECIST v1.1;
You likely can't join if
- Patients who previously received selective FGFR targeting therapy;
- Received approved or researched systemic anti-tumor treatment within 3 weeks prior to the start of the study treatment;
- Radical radiotherapy within 4 weeks;
- Have received local anti-tumor treatment within 4 weeks;
- Major surgery requiring hospitalization or incomplete healing of the surgery incision within 4 weeks;
- Current or prior history of retinal detachment;
See the full eligibility criteria
- Have fully understood the study and voluntarily signed the ICF;
- Age ≥ 18 years;
- a. pathologically or cytologically confirmed advanced treatment failure solid tumor with standard patients (applicable to cohorts2 stage I); b. histologically or cytologically confirmed histologically or cytologically...
- a. The patients have received at least one prior systemic treatment regimen for advanced ICC and has intolerable PD or toxicity(Cohort1-3); b. Patients who have not received any prior systemic therapy for advanced...
- Measurable lesion according to RECIST v1.1;
- ECOG performance status of 0 or 1;
- Life expectancy ≥ 12 weeks;
- Female patients or male patients with partners of childbearing potential must take effective contraceptive measures per the protocol.
- Patients who previously received selective FGFR targeting therapy;
- Received approved or researched systemic anti-tumor treatment within 3 weeks prior to the start of the study treatment;
- Radical radiotherapy within 4 weeks;
- Have received local anti-tumor treatment within 4 weeks;
- Major surgery requiring hospitalization or incomplete healing of the surgery incision within 4 weeks;
- Current or prior history of retinal detachment;
- Using a strong inducer or inhibitor of cytochrome P450 3A (CYP3A) within 2 weeks or 5 half-lives of the study treatment;
- Taking drugs or dietary supplementsthat may cause blood phosphorus and/or blood calcium to rise within 2 weeks prior to the start of the study treatment;
- International normalized ratio above 1.5 or partial activated prothrombin time above 1.5 times ULN;
- History of clinically significant active hepatopathy, including active viral hepatitis, or other active hepatitis, clinically significant moderate to severe liver cirrhosis;
- The patients with human immunodeficiency virus (HIV) infection;
- Active infection requiring systemic treatment within 1 week prior to the start of the study treatment;
- Screening blood phosphorus levels above ULN, or history of abnormal calcium phosphorus metabolism requiring clinical intervention or relevant medical history;
- Currently keratopathy confirmed by ophthalmological examination;
- Prior history of retinal detachment, or current diseases that may cause retinal detachment;
- Clinically significant arrhythmia or conduction abnormalities requiring clinical intervention;
- Patients with known deep venous thrombosis, treated with low molecular weight heparin (LMWH) or drugs with similar how well it works, and the investigator judges that the thrombosis is stable for ≥ 2 weeks ;
- Toxicities caused by prior anti-tumor treatment have not recovered to grade 0 or 1;
- The patient has any current disease or condition that affects drug absorption, or the patient cannot be orally administered;
- Combined with other malignant tumor or a history of other malignant tumor within 5 years prior to study screening;
- Patients currently has central nervous system metastases, meningeal metastases or spinal cord compression, except in individual cases;
- Any other medical condition or clinically significant laboratory abnormalities judged by the investigator would make the patients unsuitable to participate in this study.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.