A Study of HMPL-415S1 in Patients With Advanced Malignant Solid Tumors
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
1 other identifier
interventional
81
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jul 2023
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 23, 2023
CompletedFirst Posted
Study publicly available on registry
June 2, 2023
CompletedStudy Start
First participant enrolled
July 6, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2026
ExpectedJuly 21, 2023
July 1, 2023
1.9 years
May 23, 2023
July 19, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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
from Cycle 0Day1 up to Cycle1Day28 (each cycle is 28 days).
Secondary Outcomes (9)
To investigate the pharmacokinetic (PK) profile of oral HMPL-415S1
from pre-dose to day 5 of cycle 0. (cycle 0 contains 5 days).
AUCinf (Cycle 0 ) of HMPL-415S1
from pre-dose to day 5 of cycle 0. (cycle 0 contains 5 days).
AUC(0-tlast) (Cycle 0 ) of HMPL-415S1
from pre-dose to day 5 of cycle 0. (cycle 0 contains 5 days).
Objective Response Rate (ORR)
From baseline to final assessment at end of safety follow-up visit (up to a maximum of approximately 3 years).
Disease control rate (DCR)
From baseline to final assessment at end of safety follow-up visit (up to a maximum of approximately 3 years).
- +4 more secondary outcomes
Study Arms (1)
HMPL-415S1
EXPERIMENTALHMPL-415S1 will be administered orally once daily in 28 days treatment cycles
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hutchmedlead
Study Sites (1)
Zhongshan Hospital Fudan University
Shanghai, Shanghai Municipality, 200032, China
Study Officials
- STUDY DIRECTOR
Bin Yang
Hutchison Medipharma Limited
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 23, 2023
First Posted
June 2, 2023
Study Start
July 6, 2023
Primary Completion
May 31, 2025
Study Completion (Estimated)
June 30, 2026
Last Updated
July 21, 2023
Record last verified: 2023-07
Data Sharing
- IPD Sharing
- Will not share