Solid TumorPhase 1/2NCT05173142
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 1/2 study testing HMPL-453, gemcitabine and cisplatin and toripalimab in people with Solid Tumor, run by Hutchison Medipharma Limited at 1 site in China.
Trial summary
A Phase Ib/II Clinical Study Evaluating HMPL-453 Tartrate as Monotherapy and in Combination with Chemotherapy or Toripalimab in Advanced Solid Tumors Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Solid Tumor
- What is being tested?
- HMPL-453, gemcitabine and cisplatin and toripalimab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 190 participants
- Where
- 1 siteChina
- Study dates
- 22 Jan 2022to 17 Jan 2026
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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；
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
A Phase Ib/II Clinical Study Evaluating HMPL-453 Tartrate as Monotherapy and in Combination with Chemotherapy or Toripalimab in Advanced Solid Tumors
Read the detailed description
The study includes a dose escalation phase and a dose-expansion phase.
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 monotherapy or combination therapy.
- Conditions
- Solid Tumor
- Being tested
- HMPL-453, gemcitabine and cisplatin, toripalimab, Docetaxel
- Keywords
- HMPL-453, FGFR, PD-1,IHCC, ICC, gastric cancer
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HMPL-453Drug
HMPL-453 administered orally.
gemcitabine and cisplatinDrug
Gemcitabine and Cisplatin administered intravenously.
toripalimabDrug
Toripalimab administered intravenously.
DocetaxelDrug
Docetaxel administered intravenously.
| Study group | Role | What they receive |
|---|---|---|
| dose escalation phase of HMPL-453 monotherapy or combination therapy | Experimental | HMPL-453 monotherapy or combination therapy Receives: Drug: HMPL-453; Drug: gemcitabine and cisplatin; Drug: toripalimab |
| indication specific dose expansion phase of HMPL-453 monotherapy or combination therapy | Experimental | HMPL-453 monotherapy or combination chemotherapy, in patients with IHCC, G/GEJ, UC, and solid tumors harboring specific FGFR gene alterations Receives: Drug: HMPL-453; Drug: gemcitabine and cisplatin; Drug: toripalimab; Drug: Docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability(Incidence and severity of adverse events (AEs))
DLT, TEAEs and SAEs
Measured: 6 months after the last patient enrolled
Preliminary efficacy/Objective response rate (ORR)
Objective response rate (ORR) in patients with the selected tumors along with certain FGFR gene alterations
Measured: up to 2 years
Secondary outcomes (5)
Efficacy/Progression-free survival (PFS)
the duration between the enrollment date and the first disease progression (PD) or death (whichever comes first).
Measured: up to 2 years
disease control rate (DCR)
The incidence of complete response, partial response and stable disease
Measured: up to 2 years
time to response (TTR)
The period from the date of enrollment to the date when the criteria for complete response or partial response was first measured (first record shall prevail).
Measured: up to 2 years
duration of response (DoR）
The duration between the date the criteria for complete response or partial response was first measured (first record shall prevail) and the date of disease recurrence or progression as objectively recorded
Measured: up to 2 years
overall survival (OS)
The period from date of enrollment to date of death
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2021
- Study start22 Jan 2022
- Primary completion17 Jul 2025
- Study completion17 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 190 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hutchison Medipharma Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05173142
- Sponsor's protocol ID
- 2021-453-00CH1
- Status last verified
- May 2026
- First submitted
- 31 Oct 2021
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05173142
- Acronym / sponsor ID
- 2021-453-00CH1
- Conditions
- Solid Tumor
- Keywords
- HMPL-453, FGFR, PD-1,IHCC, ICC, gastric cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 190 participants (actual)
- Lead sponsor
- Hutchison Medipharma LimitedIndustry (pharma, biotech, devices)
- Study start
- 22 Jan 2022 (actual)
- Primary completion
- 17 Jul 2025 (actual)
- Study completion
- 17 Jan 2026 (actual)
- First posted
- 29 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Phase Ib/II Clinical Study Evaluating HMPL-453 Tartrate as Monotherapy and in Combination with Chemotherapy or Toripalimab in Advanced Solid Tumors
Detailed description
The study includes a dose escalation phase and a dose-expansion phase.
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 monotherapy or combination therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dose escalation phase of HMPL-453 monotherapy or combination therapy | Experimental | Drug: HMPL-453, Drug: gemcitabine and cisplatin, Drug: toripalimabHMPL-453 monotherapy or combination therapy |
| indication specific dose expansion phase of HMPL-453 monotherapy or combination therapy | Experimental | Drug: HMPL-453, Drug: gemcitabine and cisplatin, Drug: toripalimab, Drug: DocetaxelHMPL-453 monotherapy or combination chemotherapy, in patients with IHCC, G/GEJ, UC, and solid tumors harboring specific FGFR gene alterations |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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;
Key exclusion criteria (13 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HMPL-453HMPL-453 administered orally. | Drug | dose escalation phase of HMPL-453 monotherapy or combination therapy, indication specific dose expansion phase of HMPL-453 monotherapy or combination therapy |
| gemcitabine and cisplatinGemcitabine and Cisplatin administered intravenously. | Drug | dose escalation phase of HMPL-453 monotherapy or combination therapy, indication specific dose expansion phase of HMPL-453 monotherapy or combination therapy |
| toripalimabToripalimab administered intravenously. | Drug | dose escalation phase of HMPL-453 monotherapy or combination therapy, indication specific dose expansion phase of HMPL-453 monotherapy or combination therapy |
| DocetaxelDocetaxel administered intravenously. | Drug | indication specific dose expansion phase of HMPL-453 monotherapy or combination therapy |
Primary outcome
Safety and tolerability(Incidence and severity of adverse events (AEs))
Time frame: 6 months after the last patient enrolled
DLT, TEAEs and SAEs
Preliminary efficacy/Objective response rate (ORR)
Time frame: up to 2 years
Objective response rate (ORR) in patients with the selected tumors along with certain FGFR gene alterations
5 secondary outcomes
Efficacy/Progression-free survival (PFS)
Time frame: up to 2 years
disease control rate (DCR)
Time frame: up to 2 years
time to response (TTR)
Time frame: up to 2 years
duration of response (DoR）
Time frame: up to 2 years
overall survival (OS)
Time frame: up to 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing HMPL-453, gemcitabine and cisplatin and toripalimab in people with Solid Tumor, run by Hutchison Medipharma Limited at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability(Incidence and severity of adverse events (AEs)) (time frame: 6 months after the last patient enrolled). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2026.