Advanced Malignant Solid TumorsPhase 1NCT05277454
Clinical Study of HMPL-653 in Treatment of Advanced Malignant Solid Tumors and TGCT
A Phase 1 study testing HMPL-653 in people with Advanced Malignant Solid Tumors and TGCT, run by Hutchison Medipharma Limited at 5 sites in China.
Trial summary
To evaluate the safety and tolerability of HMPL-653 in patients with advanced solid tumors who have failure of standard of care or can not tolerate standard of care or those with TGCT, and to determine the maximum tolerated dose (MTD) and/or the recommended phase II clinical study dose (RP2D) of HMPL-653 in patients… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Malignant Solid Tumors, TGCT
- What is being tested?
- HMPL-653
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 113 participants
- Where
- 5 sitesChina
- Study dates
- 18 Jan 2022to 14 Apr 2025
- Phase
- Phase 1
- 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
- Able to understand and willing to sign the ICF.
- Aged 18 to 75 years.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Life expectancy at least 12 weeks.
- Adequate bone marrow, liver and kidney function.
Who cannot join
- Toxicity associated with previous antitumor therapy not recovered to ≤CTCAE grade 1；
- Previous treatment with anti-CSF1R therapy and have progressive disease;
- Receiving approved systematic antitumor therapy or in the treatment period of other interventional clinical study within 4 weeks prior to the first dose.
- Patients with central nervous system (CNS) malignant tumor or malignant solid tumor with known CNS metastasis;
- Pregnant or lactating women.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
China5 sites, 5 recruiting
- Recruiting
Jilin Provincial Cancer Hospital
Changchun
Ying Cheng, Prof
- Not yet recruiting
Harbin Medical University Cancer Hospital
Harbin
Yanqiao Zhang, Prof
- Not yet recruiting
Linyi Cancer Hospital
Linyi
Jianhua Shi, Prof
- Not yet recruiting
Henan Cancer Hospital
Zhengzhou
Suxia Luo, Prof
- Not yet recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou
Weijie Zhang, Prof
About this study
Official title: A Multicenter, Open-label, Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of HMPL-653 in Treatment of Patients With Advanced Malignant Solid Tumors and Tenosynovial Giant Cell Tumor
To evaluate the safety and tolerability of HMPL-653 in patients with advanced solid tumors who have failure of standard of care or can not tolerate standard of care or those with TGCT, and to determine the maximum tolerated dose (MTD) and/or the recommended phase II clinical study dose (RP2D) of HMPL-653 in patients with advanced solid tumors.
- Conditions
- Advanced Malignant Solid Tumors, TGCT
- Being tested
- HMPL-653
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HMPL-653Drug
Dose-escalation Stage:
Several dose levels will be evaluated for HMPL-653. The participants will receive oral HMPL-653 single-dose evaluation and oral HMPL-653 QD continuously treatment in a therapeutic cycle of 28 days until reaching the criteria for the end of treatment.
Dose-expansion Stage:
The participants will receive HMPL-653 treatment （RP2D）until reaching the criteria for the end of treatment.
| Study group | Role | What they receive |
|---|---|---|
| HMPL-653 open-label treatment arm | Experimental | Dose-escalation Stage:
Participants will be treated with escalating doses of HMPL-653 to determine the MTD and RP2D.
Dose-expansion Stage:
Participants will be enrolled in the expansion stage to better characterize the safety, tolerability, PK variability, and preliminary efficacy of HMPL-653 in TGCT and specific advanced solid tumors. Receives: Drug: HMPL-653 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of Dose-Limiting Toxicities(DLTs)
To evaluate the safety and tolerability of HMPL-653 for dose escalation period
Measured: up to 33 days
Maximum tolerated dose (MTD)
The Maximum tolerated dose of HMPL-653
Measured: up to 12 months
Recommended phase II dose (RP2D)
Recommended phase II dose of HMPL-653
Measured: up to 12 months
Secondary outcomes (16)
Pharmacokinetic-Cmax
Peak concentration of Pharmacokinetic
Measured: up to 9 weeks
Pharmacokinetic-Tmax
Time to peak concentration of Pharmacokinetic
Measured: up to 9 weeks
Pharmacokinetic-Ctrough
Trough concentration of Pharmacokinetic
Measured: up to 9 weeks
Pharmacokinetic-t1/2
Terminal elimination half-life of Pharmacokinetic
Measured: up to 9 weeks
Pharmacokinetic-AUC0-t
Area under the plasma concentration-time curve of Pharmacokinetic
Measured: up to 9 weeks
Pharmacokinetic-AUC0-∞
Area under the plasma concentration-time curve of Pharmacokinetic
Measured: From first dose up to C3D1, estimated up to 9 weeks
Pharmacokinetic-AUC0-τ
Area under the plasma concentration-time curve of Pharmacokinetic
Measured: up to 9 weeks
Pharmacokinetic-CL/F
Apparent clearance of Pharmacokinetic
Measured: up to 9 weeks
Pharmacokinetic-Vz/F
Apparent volume of distribution in the terminal phase of Pharmacokinetic
Measured: up to 9 weeks
Pharmacokinetic-AR
AUC-based accumulation coefficient of Pharmacokinetic
Measured: up to 9 weeks
Objective response rate (ORR)
The incidence of confirmed complete response or partial response.
Measured: 12 months
Progression-free survival (PFS)
The time from the first dose of study treatment to PD or death for any reason, whichever comes first.
Measured: 12 months
Disease control rate (DCR)
The proportion of patients with confirmed CR or PR or stable disease (SD) as the best response, and the duration of SD needs to be ≥6 weeks.
Measured: 12 months
Time to response (TTR)
The time from the first dose of HMPL-653 to the first objective response.
Measured: 12 months
Duration of response (DoR)
The time from the first appearance of confirmed CR or PR to PD or death for any reason (whichever comes first), in the patients with objective response.
Measured: 12 months
Overall survival (OS)
The time from the first dose of study treatment to death for any reason.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2022
- Study start18 Jan 2022
- Primary completion28 Jun 2024 (estimated)
- Study completion14 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Malignant Solid TumorsStudies 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 113 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hutchison Medipharma Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ying Cheng, Prof, Principal investigator, Jilin Provincial Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05277454
- Sponsor's protocol ID
- 2021-653-00CH1
- Status last verified
- Jan 2022
- First submitted
- 6 Feb 2022
- Last updated
- 14 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-label, Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of HMPL-653 in Treatment of Patients With Advanced Malignant Solid Tumors and Tenosynovial Giant Cell Tumor
- ClinicalTrials.gov ID
- NCT05277454
- Acronym / sponsor ID
- 2021-653-00CH1
- Conditions
- Advanced Malignant Solid Tumors, TGCT
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 113 participants (estimated)
- Lead sponsor
- Hutchison Medipharma LimitedIndustry (pharma, biotech, devices)
- Study start
- 18 Jan 2022 (actual)
- Primary completion
- 28 Jun 2024 (estimated)
- Study completion
- 14 Apr 2025 (estimated)
- First posted
- 14 Mar 2022 (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.
To evaluate the safety and tolerability of HMPL-653 in patients with advanced solid tumors who have failure of standard of care or can not tolerate standard of care or those with TGCT, and to determine the maximum tolerated dose (MTD) and/or the recommended phase II clinical study dose (RP2D) of HMPL-653 in patients with advanced solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HMPL-653 open-label treatment arm | Experimental | Drug: HMPL-653Dose-escalation Stage: Participants will be treated with escalating doses of HMPL-653 to determine the MTD and RP2D. Dose-expansion Stage: Participants will be enrolled in the expansion stage to better characterize the safety, tolerability, PK variability, and preliminary efficacy of HMPL-653 in TGCT and specific advanced solid tumors. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Able to understand and willing to sign the ICF.
- Aged 18 to 75 years.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Life expectancy at least 12 weeks.
- Adequate bone marrow, liver and kidney function.
Key exclusion criteria (5 listed)
- Toxicity associated with previous antitumor therapy not recovered to ≤CTCAE grade 1；
- Previous treatment with anti-CSF1R therapy and have progressive disease;
- Receiving approved systematic antitumor therapy or in the treatment period of other interventional clinical study within 4 weeks prior to the first dose.
- Patients with central nervous system (CNS) malignant tumor or malignant solid tumor with known CNS metastasis;
- Pregnant or lactating women.
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-653Dose-escalation Stage: Several dose levels will be evaluated for HMPL-653. The participants will receive oral HMPL-653 single-dose evaluation and oral HMPL-653 QD continuously treatment in a therapeutic cycle of 28 days until reaching the criteria for the end of treatment. Dose-expansion Stage: The participants will receive HMPL-653 treatment （RP2D）until reaching the criteria for the end of treatment. | Drug | HMPL-653 open-label treatment arm |
Primary outcome
Occurrence of Dose-Limiting Toxicities(DLTs)
Time frame: up to 33 days
To evaluate the safety and tolerability of HMPL-653 for dose escalation period
Maximum tolerated dose (MTD)
Time frame: up to 12 months
The Maximum tolerated dose of HMPL-653
Recommended phase II dose (RP2D)
Time frame: up to 12 months
Recommended phase II dose of HMPL-653
16 secondary outcomes
Pharmacokinetic-Cmax
Time frame: up to 9 weeks
Pharmacokinetic-Tmax
Time frame: up to 9 weeks
Pharmacokinetic-Ctrough
Time frame: up to 9 weeks
Pharmacokinetic-t1/2
Time frame: up to 9 weeks
Pharmacokinetic-AUC0-t
Time frame: up to 9 weeks
Pharmacokinetic-AUC0-∞
Time frame: From first dose up to C3D1, estimated up to 9 weeks
Pharmacokinetic-AUC0-τ
Time frame: up to 9 weeks
Pharmacokinetic-CL/F
Time frame: up to 9 weeks
Pharmacokinetic-Vz/F
Time frame: up to 9 weeks
Pharmacokinetic-AR
Time frame: up to 9 weeks
Objective response rate (ORR)
Time frame: 12 months
Progression-free survival (PFS)
Time frame: 12 months
Disease control rate (DCR)
Time frame: 12 months
Time to response (TTR)
Time frame: 12 months
Duration of response (DoR)
Time frame: 12 months
Overall survival (OS)
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2022.
- Individual participant dataSharing planned: No
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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.
Ying Cheng, Prof principal investigator
Jilin Provincial Cancer Hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HMPL-653 in people with Advanced Malignant Solid Tumors and TGCT, run by Hutchison Medipharma Limited at 5 sites 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 5 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 14 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cindy Hua (+86 21 2067 3221, cindyh@hutch-med.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of Dose-Limiting Toxicities(DLTs) (time frame: up to 33 days). The study lists 3 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 14 Mar 2022.