A Phase Ib/II Clinical Study Evaluating HMPL-453 Tartrate as Monotherapy and in Combination With … (NCT05173142) | Clinical Trial Compass
CompletedPhase 1/2
A Phase Ib/II Clinical Study Evaluating HMPL-453 Tartrate as Monotherapy and in Combination With Chemotherapy or Toripalimab in Advanced Solid Tumors
China190 participantsStarted 2022-01-22
Plain-language summary
A Phase Ib/II Clinical Study Evaluating HMPL-453 Tartrate as Monotherapy and in Combination with Chemotherapy or Toripalimab in Advanced Solid Tumors
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria
* Dose escalation phase: patients with histologically or cytologically confirmed locally advanced or metastatic solid tumor who progressed on or are intolerant of standard therapy;
* Dose expansion phase: patients with UC, GC/GEJ, or IHCC harboring specific FGFR gene alterations;
* Age 18 to 75 years;
* Those who are able to give written informed consent, and able to comply with protocol-specified visits and related procedures;
* Ability to swallow study drug;
* ECOG PS of 0 or 1;
* Measurable lesion according to RECIST v1.1, refer to the protocol;
* Adequate organ and bone marrow function;
* Life expectancy ≥ 12 weeks;
* Female patients or male patients with partners of childbearing potential must take effective contraceptive measures per the protocol.
Exclusion Criteria
* Patients who previously received selective FGFR targeting therapy;
* Concurrent participation in another interventional clinical study, excluding those in the follow-up period and have not recently received investigational intervention;
* Current or previous history of central nervous system (CNS) metastases；
* Current or previous history of retinal detachment；
* Known history of primary immunodeficiency;
* Female patients who are pregnant or lactating；
* Patients who in the opinion of the investigator may be unsuitable for participating in the study;
* Patients with acute or chronic active hepatitis B or C infection;
* Known human immunodeficiency virus (HIV) infection and syphilis i…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Safety and tolerability(Incidence and severity of adverse events (AEs))
Timeframe: 6 months after the last patient enrolled