NCT05173142CompletedPhase 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
A Phase Ib/II Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of HMPL-453 Tartrate as Monotherapy and in Combination With Chemotherapy or Toripalimab in Patients With Advanced Solid Tumors
Source: ClinicalTrials.gov · Last updated 15 May 2026
Brief summary (registry, in English)
A Phase Ib/II Clinical Study Evaluating HMPL-453 Tartrate as Monotherapy and in Combination with Chemotherapy or Toripalimab in Advanced Solid Tumors
- Status (registry)
- Completed
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 190 (actual)
- First submitted
- 31 Oct 2021
- Start date
- 22 Jan 2022
- Primary completion date
- 17 Jul 2025
- Lead sponsor
- Hutchison Medipharma Limited
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT05173142
What you commit to
- Study type: Interventional · Phase 1/2
- Participants enrolled: 190
- From 22 Jan 2022 to the primary completion date, 17 Jul 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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；
- 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.
Other illness
- Known history of primary immunodeficiency;
- 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；
Other
- Female patients who are pregnant or lactating；
- Patients who in the opinion of the investigator may be unsuitable for participating in the study;
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Chinese PLA General Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.