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

NCT07028281 | Recruiting Phase 2

• 1 other identifier: SHR-4849-201
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• DLT：the incidence of events associated with the investigational drug determined by the investigator during the observation period(The first stage)

  up to 21 days

• Incidence and severity of AE/SAE：According to NCI-CTCAE v5.0 evaluation criteria, from the signing of informed consent to the end of safety follow-up(The first stage)

  up to 24 months

• Objective Response Rate (ORR) as Assessed by investigators(The second stage)

  up to 24 months

Secondary Outcomes (10)

• ORR(The first stage)

  up to 24 months

• DoR(The first stage)

  up to 24 months

• DCR(The first stage)

  up to 24 months

• PFS(The first stage)

  up to 24 months

• OS(The first stage)

  up to 30 months

Study Arms (1)

Treatment group A

EXPERIMENTAL

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

Interventions

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

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

Treatment group A

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject has provided informed consent prior to initiation of any study-procedures
• Age from 18 to 75 years old at the time of signing the informed consent
• Histologically or cytologically confirmed solid tumors
• At least one measurable lesion was identified per RECIST 1.1
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
• Has a life expectancy of at least 3 months.
• Adequate organ function
• 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

You may not qualify if:

• Subjects with active central nervous system (CNS) metastasis.
• Subjects with a history of malignant tumors within 5 years prior to the first dose
• Subjects with uncontrolled cancer pain.
• Subjects with severe cardiovascular disease.
• Subjects with clinically significant hemorrhage
• Subjects with uncontrolled pleural effusion, peritoneal effusion and pericardial effusion
• Subjects highly suspected of interstitial lung disease
• Subjects with serious infection within 4 weeks prior to the first dose
• Known history of human immunodeficiency virus (HIV)，active hepatitis B virus or hepatitis C virus infection.
• The adverse events of previous antineoplastic therapy did not recover to NCI-CTCAE≤ grade 1
• Subjects who received anti-cancer treatment within 4 weeks prior to the first dose
• Subjects who received major surgery within 4 weeks prior to the first dose
• Subjects who plan to receive or have received live vaccines within 28 days prior to the first dose.
• Female subjects who were pregnant, lactating, or planned to become pregnant during the study period
• Known allergic to any component of investigational drugs

Sponsors & Collaborators

• Suzhou Suncadia Biopharmaceuticals Co., Ltd.: lead

Study Sites (1)

Affiliated Cancer Hospital of Shandong First Medical University

Jinan, Shandong, 250117, China

RECRUITING

Central Study Contacts

Wei Hou

CONTACT

0518-82342973; wei.hou@hengrui.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2025
• First Posted: June 19, 2025
• Study Start: July 8, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: March 3, 2026

Record last verified: 2025-06

Locations

CN (1)