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

NCT ID: NCT05886374

Last Updated: 2023-07-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 81 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-06
• Study Completion Date: 2026-06-30

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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

HMPL-415S1

HMPL-415S1 will be administered orally once daily in 28 days treatment cycles

Group Type: EXPERIMENTAL

HMPL-415S1

Intervention Type: DRUG

HMPL-415S1 will be supplied as 0.5 mg, 5 mg and 25 mg capsules

Interventions

HMPL-415S1

HMPL-415S1 will be supplied as 0.5 mg, 5 mg and 25 mg capsules

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hutchmed

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bin Yang

Role: STUDY_DIRECTOR

Hutchison Medipharma Limited

Locations

Zhongshan Hospital Fudan University

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Ronghua Zhang

Role: CONTACT

ronghuaz@hutch-med.com

+86 1526711056

Yanbing Huang

Role: CONTACT

yanbingh@hutch-med.com

+86 13724153286

Facility Contacts

Tianshu Liu

Role: primary

Other Identifiers

2022-415-00CH1

Identifier Type: -

Identifier Source: org_study_id