A Study of HMPL-415S1 in Patients With Advanced Malignant Solid Tumors

Launched by HUTCHMED · May 23, 2023

Keywords

ClinConnect Summary

**Trial Summary: Study of HMPL-415S1 for Patients with Advanced Solid Tumors**

This clinical trial is investigating a new treatment called HMPL-415S1 for patients with advanced malignant solid tumors, which are types of cancer that have spread beyond their original location. The main goals of this study are to find out how safe the treatment is, how well it is tolerated by patients, and to determine the highest dose that can be given without causing harmful side effects. The trial is currently recruiting participants who are between the ages of 18 and 75 and have already received other cancer treatments that were not effective or could not be tolerated.

To be eligible for the study, participants must have a confirmed diagnosis of an advanced solid tumor, have at least one measurable tumor that can be assessed, and should generally be in good health, with a life expectancy of at least 12 weeks. They should not have received certain previous treatments or have specific medical conditions that could interfere with the study. If you choose to participate, you will be closely monitored by healthcare professionals throughout the trial, and you may receive the study drug or a placebo (a non-active treatment). This trial offers an opportunity to access a new treatment option while contributing to important research that could benefit future patients.

Gender

ALL

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.