A Study of SHR-4602 in Subjects With Advanced Malignant Solid Tumors

NCT ID: NCT05819684

Last Updated: 2024-06-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 133 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-18
• Study Completion Date: 2026-05-30

Brief Summary

This is an open-label, three-part study to evaluate the safety, tolerability, pharmacokinetics and immunogenicity of SHR-4602 and preliminary anti-tumor efficacy in HER2 expressing or mutated advanced malignant solid tumor subjects.

Conditions

Advanced Solid Tumor

Study Design

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

Study Groups

Part 1: Dose escalation

Group Type: EXPERIMENTAL

SHR-4602 for injection

Intervention Type: DRUG

be administered via intravenous (IV) infusion

Part 2: PK expansion

Group Type: EXPERIMENTAL

SHR-4602 for injection

Intervention Type: DRUG

be administered via intravenous (IV) infusion

Part 3: efficacy expansion

Group Type: EXPERIMENTAL

SHR-4602 for injection

Intervention Type: DRUG

be administered via intravenous (IV) infusion

Interventions

SHR-4602 for injection

be administered via intravenous (IV) infusion

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Advanced/unresectable or metastatic solid tumor with HER2 expression or mutation that is refractory to or intolerable with standard treatment, or for which no standard treatment is available;

2. At least one measurable lesion based on RECIST v1.1 criteria;

3. ECOG PS score: 0-1 points;

4. Expected survival period ≥ 3 months;

5. Adequate organ function;

6. Must take one medically approved contraceptive measure;

7. Patients voluntarily joined the study and signed informed consent.

Exclusion Criteria

1. Patients with known CNS metastasis or hepatic encephalopathy;

2. Suffering from peripheral neuropathy;

3. History of clinically significant lung diseases (e.g., interstitial pneumonia, pneumonitis, pulmonary fibrosis, and severe radiation pneumonitis) or suspected to have these diseases by imaging at screening period;

4. Patients with any active, known or suspected autoimmune disorder;

5. With known severe allergic reactions to any other monoclonal antibodies;

6. Patients with symptomatic ascites or pleural effusion requiring paracentesis and drainage, or patients who have undergone ascites or pleural effusion drainage within 2 weeks before the first dose;

7. Patients with other malignancies currently or within the past 5 years;

8. Uncontrolled cardiac diseases or symptoms;

9. With known hereditary or acquired bleeding (e.g., coagulopathy) or a tendency to clot (e.g., hemophiliacs);

10. Patients with other potential factors that may affect the study results.

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

Sponsors

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xin Shi

Role: CONTACT

xin.shi.xs3@hengrui.com

0518-82342973

Wenjie Xin

Role: CONTACT

wenjie.xin@hengrui.com

0518-82342973

Facility Contacts

Erwei Song, Doctor

Role: primary

songew@mail.sysu.edu.cn

Herui Yao, Doctor

Role: backup

yaoherui@163.com

Other Identifiers

SHR-4602-I-101

Identifier Type: -

Identifier Source: org_study_id