HMPL-453 (FGFR Inhibitor) in Combination With Chemotherapy or Anti-PD-1 Antibody in Advanced Solid Tumors
NCT ID: NCT05173142
Last Updated: 2022-03-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
141 participants
INTERVENTIONAL
2022-01-22
2025-08-31
Brief Summary
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Detailed Description
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Patients with advanced solid tumor will be enrolled in the dose escalation phase to assess the tolerability, safety, and PK profile of HMPL-453 monotherapy or combination therapy.
Patients with specific types of advanced or metastatic tumors harboring certain FGFR gene alterations will be enrolled in the dose expansion phase to assess the preliminary efficacy of HMPL-453 combination therapy.
Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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dose escalation phase of HMPL-453 monotherapy or combination therapy
HMPL-453 monotherapy or combination therapy
HMPL-453
HMPL-453 administered orally.
gemcitabine and cisplatin
Gemcitabine and Cisplatin administered intravenously.
toripalimab
Toripalimab administered intravenously.
indication specific dose expansion phase of HMPL-453 combination therapy
HMPL-453 combined with chemotherapy or anti-PD-1 antibody, in patients with IHCC, G/GEJ, or UC harboring specific FGFR gene alterations
HMPL-453
HMPL-453 administered orally.
gemcitabine and cisplatin
Gemcitabine and Cisplatin administered intravenously.
toripalimab
Toripalimab administered intravenously.
Docetaxel
Docetaxel administered intravenously.
Interventions
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HMPL-453
HMPL-453 administered orally.
gemcitabine and cisplatin
Gemcitabine and Cisplatin administered intravenously.
toripalimab
Toripalimab administered intravenously.
Docetaxel
Docetaxel administered intravenously.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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 infection；
* Clinically significant cardiovascular disease such as congestive heart failure or arrhythmia；
* Uncontrolled hypertension despite optimal medical management；
* Received live vaccine within 30 days before the first dose of study drug(s);
* Those who have undergone major surgical procedures (craniotomy, thoracotomy or laparotomy) within 4 weeks prior to the first study treatment or who are expected to be in need of major surgery; those with unhealed wounds, ulcers or fractures.
18 Years
75 Years
ALL
No
Sponsors
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Hutchison Medipharma Limited
INDUSTRY
Responsible Party
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Locations
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Chinese PLA General Hospital
Beijing, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2021-453-00CH1
Identifier Type: -
Identifier Source: org_study_id
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