Advanced Malignant Solid TumorsPhase 1NCT05886374
A Study of HMPL-415S1 in Patients With Advanced Malignant Solid Tumors
A Phase 1 study testing HMPL-415S1 in people with Advanced Malignant Solid Tumors, run by Hutchmed at 1 site in China.
Trial summary
The objective of this study is to evaluate the safety, tolerability and PK profile of HMPL-415S1 and determine MTD and/or RP2D in patients with advanced malignant solid tumor. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Malignant Solid Tumors
- What is being tested?
- HMPL-415S1
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteChina
- Study dates
- 6 Jul 2023to 30 Jun 2026
- 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
- All the following conditions must be met for enrollment:
- Fully understand this study and voluntarily sign the ICF;
- Dose escalation Patients with advanced malignant solid tumor confirmed by histopathology or cytology, who have failed, been intolerant or unavailable to, or have none standard treatment for various reasons; Dose expansion phase: Patients with advanced malignant solid tumor confirmed by histopathology or cytology, who have failed, been intolerant or unavailable to, or have none standard treatment for various reasons, carrying aberrant activating mutations in the KRAS pathway；
- Presence of at least one measurable lesion (RECIST 1.1 criteria);
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1 point;
- Life expectancy ≥ 12 weeks as judged by the investigator;
- Male of childbearing potential and their heterosexual partners of childbearing potential must agree to use effective methods of contraception.
Who cannot join
- A patient may not participate in this study if any of the following conditions apply:
- Patients who priorly received SHP2 inhibitors;
- Receiving the approved systemic antitumor treatment within 4 weeks prior to the first dose, including: chemotreatment, targeted treatment, immunization treatment, biological treatment, etc. (wash-out for 2 weeks for hormone treatment or traditional chinese medicine and chinese patent medicine with clear antitumor indications);
- Have been in the treatment period of other interventional clinical studies (including small molecule chemicals and large molecule antibodies) within 4 weeks prior to the first dose. If participating in a non-interventional clinical study (eg, epidemiological study), you can enroll in this study; if already in the survival follow-up period of an interventional clinical study, you can enroll in this study.
- Major surgery or radical radiotreatment (except palliative radiotreatment for metastases to bone lesions) within 4 weeks prior to first dose.
- Central nervous system (CNS) malignant tumor or known CNS metastasis;
- Having multiple factors that affect the absorption, distribution, metabolism or excretion of orally administered drugs (such as inability to swallow drugs, frequent vomiting, chronic diarrhoea, etc.);
- Any other disease, metabolic abnormality, physical examination abnormal, or clinically significant laboratory test abnormality that, in the judgment of the investigator, would compromise patient compliance or give reason to suspect that the patient has a disease or condition that would compromise the interpretation of study results or place the patient at high risk.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhongshan Hospital Fudan University
Shanghai, Shanghai Municipality, 200032
Tianshu Liu
Tianshu Liu
About this study
Official title: A Multicenter, Open-Label Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of HMPL-415S1 in Patients With Advanced Malignant Solid Tumor
The objective of this study is to evaluate the safety, tolerability and PK profile of HMPL-415S1 and determine MTD and/or RP2D in patients with advanced malignant solid tumor.
Read the detailed description
This study is expected to enroll 36-81 patients, including 26-66 patients for dose escalation, additional 10-15 patients will be enrolled at the dose level of determined RP2D.
- Conditions
- Advanced Malignant Solid Tumors
- Being tested
- HMPL-415S1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HMPL-415S1Drug
HMPL-415S1 will be supplied as 0.5 mg, 5 mg and 25 mg capsules
| Study group | Role | What they receive |
|---|---|---|
| HMPL-415S1 | Experimental | HMPL-415S1 will be administered orally once daily in 28 days treatment cycles Receives: Drug: HMPL-415S1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety, tolerability, and determine the maximum tolerated dose (MTD) and/or RP2D of HMPL-415S1 as a single oral agent in advanced malignant solid tumor
Occurrence of Dose Limiting Toxicities (DLTs) During the DLT Observation Period
Measured: from Cycle 0Day1 up to Cycle1Day28 (each cycle is 28 days).
Secondary outcomes (9)
To investigate the pharmacokinetic (PK) profile of oral HMPL-415S1
Plasma peak concentration of HMPL-415S1 (Cmax).
Measured: from pre-dose to day 5 of cycle 0. (cycle 0 contains 5 days).
AUCinf (Cycle 0 ) of HMPL-415S1
AUCinf: area under the concentration vs. time curve from zero to infinity after single (first)dose.
Measured: from pre-dose to day 5 of cycle 0. (cycle 0 contains 5 days).
AUC(0-tlast) (Cycle 0 ) of HMPL-415S1
AUC from time zero to the last data point.
Measured: from pre-dose to day 5 of cycle 0. (cycle 0 contains 5 days).
Objective Response Rate (ORR)
Percentage of patients with Complete Response(CR) or Partial Response(PR) as the best response evaluated in accordance with RECIST 1.1.
Measured: From baseline to final assessment at end of safety follow-up visit (up to a maximum of approximately 3 years).
Disease control rate (DCR)
the proportion of patients with CR or PR or stable disease (SD) as the best response, and the duration of SD needs to be ≥6 weeks.
Measured: From baseline to final assessment at end of safety follow-up visit (up to a maximum of approximately 3 years).
uration of response (DoR)
as the time from the first appearance of CR or PR to PD or death for any reason (whichever comes first), in the patients with objective response.
Measured: From baseline to final assessment at end of safety follow-up visit (up to a maximum of approximately 3 years).
Time to response (TTR)
the time from the first dose of HMPL-415S1 to the first objective response.
Measured: From baseline to final assessment at end of safety follow-up visit (up to a maximum of approximately 3 years).
Progression-free survival (PFS)
time from the first dose of study treatment to PD or death for any reason, whichever comes first.
Measured: From baseline to final assessment at end of safety follow-up visit (up to a maximum of approximately 3 years).
Overall survival (OS)
time from the first dose of study treatment to death for any reason.
Measured: From baseline to final assessment at end of safety follow-up visit (up to a maximum of approximately 3 years).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2023
- Study start6 Jul 2023
- Primary completion31 May 2025 (estimated)
- Study completion30 Jun 2026 (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.
- More trials run by HutchmedThe sponsor's other registered studies.
- 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
- 81 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hutchmed
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bin Yang, Study director, Hutchison Medipharma Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05886374
- Sponsor's protocol ID
- 2022-415-00CH1
- Status last verified
- Jul 2023
- First submitted
- 23 May 2023
- Last updated
- 21 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 21 Jul 2023. 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-415S1 in Patients With Advanced Malignant Solid Tumor
- ClinicalTrials.gov ID
- NCT05886374
- Acronym / sponsor ID
- 2022-415-00CH1
- Conditions
- Advanced Malignant Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 81 participants (estimated)
- Lead sponsor
- HutchmedIndustry (pharma, biotech, devices)
- Study start
- 6 Jul 2023 (actual)
- Primary completion
- 31 May 2025 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 2 Jun 2023 (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.
The objective of this study is to evaluate the safety, tolerability and PK profile of HMPL-415S1 and determine MTD and/or RP2D in patients with advanced malignant solid tumor.
Detailed description
This study is expected to enroll 36-81 patients, including 26-66 patients for dose escalation, additional 10-15 patients will be enrolled at the dose level of determined RP2D.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HMPL-415S1 | Experimental | Drug: HMPL-415S1HMPL-415S1 will be administered orally once daily in 28 days treatment cycles |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Fully understand this study and voluntarily sign the ICF;
- Dose escalation Patients with advanced malignant solid tumor confirmed by histopathology or cytology, who have failed, been intolerant or unavailable to, or have none standard treatment for various reasons; Dose expansion phase: Patients with advanced malignant solid tumor confirmed by histopathology or cytology, who have failed, been intolerant or unavailable to, or have none standard treatment for various reasons, carrying aberrant activating mutations in the KRAS pathway；
- Presence of at least one measurable lesion (RECIST 1.1 criteria);
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1 point;
- Life expectancy ≥ 12 weeks as judged by the investigator;
Key exclusion criteria (8 listed)
- Patients who priorly received SHP2 inhibitors;
- Receiving the approved systemic antitumor treatment within 4 weeks prior to the first dose, including: chemotreatment, targeted treatment, immunization treatment, biological treatment, etc. (wash-out for 2 weeks for hormone treatment or traditional chinese medicine and chinese patent medicine with clear antitumor indications);
- Have been in the treatment period of other interventional clinical studies (including small molecule chemicals and large molecule antibodies) within 4 weeks prior to the first dose. If participating in a non-interventional clinical study (eg, epidemiological study), you can enroll in this study; if already in the survival follow-up period of an interventional clinical study, you can enroll in this study.
- Major surgery or radical radiotreatment (except palliative radiotreatment for metastases to bone lesions) within 4 weeks prior to first dose.
- Central nervous system (CNS) malignant tumor or known CNS metastasis;
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-415S1HMPL-415S1 will be supplied as 0.5 mg, 5 mg and 25 mg capsules | Drug | HMPL-415S1 |
Primary outcome
To evaluate the safety, tolerability, and determine the maximum tolerated dose (MTD) and/or RP2D of HMPL-415S1 as a single oral agent in advanced malignant solid tumor
Time frame: from Cycle 0Day1 up to Cycle1Day28 (each cycle is 28 days).
Occurrence of Dose Limiting Toxicities (DLTs) During the DLT Observation Period
9 secondary outcomes
To investigate the pharmacokinetic (PK) profile of oral HMPL-415S1
Time frame: from pre-dose to day 5 of cycle 0. (cycle 0 contains 5 days).
AUCinf (Cycle 0 ) of HMPL-415S1
Time frame: from pre-dose to day 5 of cycle 0. (cycle 0 contains 5 days).
AUC(0-tlast) (Cycle 0 ) of HMPL-415S1
Time frame: from pre-dose to day 5 of cycle 0. (cycle 0 contains 5 days).
Objective Response Rate (ORR)
Time frame: From baseline to final assessment at end of safety follow-up visit (up to a maximum of approximately 3 years).
Disease control rate (DCR)
Time frame: From baseline to final assessment at end of safety follow-up visit (up to a maximum of approximately 3 years).
uration of response (DoR)
Time frame: From baseline to final assessment at end of safety follow-up visit (up to a maximum of approximately 3 years).
Time to response (TTR)
Time frame: From baseline to final assessment at end of safety follow-up visit (up to a maximum of approximately 3 years).
Progression-free survival (PFS)
Time frame: From baseline to final assessment at end of safety follow-up visit (up to a maximum of approximately 3 years).
Overall survival (OS)
Time frame: From baseline to final assessment at end of safety follow-up visit (up to a maximum of approximately 3 years).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2023.
- 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.
Bin Yang study director
Hutchison Medipharma Limited
1 site 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-415S1 in people with Advanced Malignant Solid Tumors, run by Hutchmed 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 7 inclusion and 8 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 21 Jul 2023. 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 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 Ronghua Zhang (+86 1526711056, ronghuaz@hutch-med.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the safety, tolerability, and determine the maximum tolerated dose (MTD) and/or RP2D of HMPL-415S1 as a single oral agent in advanced malignant solid tumor (time frame: from Cycle 0Day1 up to Cycle1Day28 (each cycle is 28 days).). 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 21 Jul 2023.