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Trial Title:
A Study of HMPL-415S1 in Patients With Advanced Malignant Solid Tumors
NCT ID:
NCT05886374
Condition:
Advanced Malignant Solid Tumors
Conditions: Official terms:
Neoplasms
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
HMPL-415S1
Description:
HMPL-415S1 will be supplied as 0.5 mg, 5 mg and 25 mg capsules
Arm group label:
HMPL-415S1
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.
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
All the following conditions must be met for enrollment:
1. Fully understand this study and voluntarily sign the ICF;
2. 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；
3. Presence of at least one measurable lesion (RECIST 1.1 criteria);
4. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1 point;
5. Life expectancy ≥ 12 weeks as judged by the investigator;
6. Male of childbearing potential and their heterosexual partners of childbearing
potential must agree to use effective methods of contraception.
Exclusion Criteria:
A patient may not participate in this study if any of the following conditions apply:
1. Patients who priorly received SHP2 inhibitors;
2. 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);
3. 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.
4. Major surgery or radical radiotreatment (except palliative radiotreatment for
metastases to bone lesions) within 4 weeks prior to first dose.
5. Central nervous system (CNS) malignant tumor or known CNS metastasis;
6. 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.);
7. 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Zhongshan Hospital Fudan University
Address:
City:
Shanghai
Zip:
200032
Country:
China
Status:
Recruiting
Contact:
Last name:
Tianshu Liu
Investigator:
Last name:
Tianshu Liu
Email:
Principal Investigator
Start date:
July 6, 2023
Completion date:
June 30, 2026
Lead sponsor:
Agency:
Hutchmed
Agency class:
Industry
Source:
Hutchmed
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05886374
