A Trial of SHR-4849 Combined With Other Antitumor Drugs in Patients With Malignant Solid Tumors

NCT ID: NCT07028281

Last Updated: 2025-09-29

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-08
• Study Completion Date: 2028-12-31

Brief Summary

The study is being conducted to evaluate the safety, tolerability and efficacy of SHR-4849 injection combined with other antitumor drugs in patients with malignant solid tumors.

Conditions

Malignant Solid Tumors

Study Design

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

Study Groups

Treatment group A

Group Type: EXPERIMENTAL

SHR-4849、SHR-1316、SHR-8068、BP102、carboplatin、cisplatin

Intervention Type: DRUG

SHR-4849、SHR-1316、SHR-8068、BP102、carboplatin、cisplatin

Interventions

SHR-4849、SHR-1316、SHR-8068、BP102、carboplatin、cisplatin

SHR-4849、SHR-1316、SHR-8068、BP102、carboplatin、cisplatin

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Subject has provided informed consent prior to initiation of any study-procedures

2. Age from 18 to 75 years old at the time of signing the informed consent

3. Histologically or cytologically confirmed solid tumors

4. At least one measurable lesion was identified per RECIST 1.1

5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1

6. Has a life expectancy of at least 3 months.

7. Adequate organ function

8. Subjects of both genders of child-bearing potential were required to use highly effective contraception from the time they provided written informed consent until 8 months after the last dose of the trial drug

Exclusion Criteria

1. Subjects with active central nervous system (CNS) metastasis.

2. Subjects with a history of malignant tumors within 5 years prior to the first dose

3. Subjects with uncontrolled cancer pain.

4. Subjects with severe cardiovascular disease.

5. Subjects with clinically significant hemorrhage

6. Subjects with uncontrolled pleural effusion, peritoneal effusion and pericardial effusion

7. Subjects highly suspected of interstitial lung disease

8. Subjects with serious infection within 4 weeks prior to the first dose

9. Known history of human immunodeficiency virus (HIV)，active hepatitis B virus or hepatitis C virus infection.

10. The adverse events of previous antineoplastic therapy did not recover to NCI-CTCAE≤ grade 1

11. Subjects who received anti-cancer treatment within 4 weeks prior to the first dose

12. Subjects who received major surgery within 4 weeks prior to the first dose

13. Subjects who plan to receive or have received live vaccines within 28 days prior to the first dose.

14. Female subjects who were pregnant, lactating, or planned to become pregnant during the study period

15. Known allergic to any component of investigational drugs

16. Alcohol abuse, drug abuse, other serious medical conditions (including mental illness) requiring combined treatment, and other conditions that may affect subject safety or data collection.

17. Based on the investigator's judgment, subjects with other conditions that may affect study results, interfere with study procedures,

• 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

Affiliated Cancer Hospital of Shandong First Medical University

Jinan, Shandong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Wei Hou

Role: CONTACT

wei.hou@hengrui.com

0518-82342973

Other Identifiers

SHR-4849-201

Identifier Type: -

Identifier Source: org_study_id