A Phase I/II Clinical Study of SHR-4298 Injection in Patients With Malignant Solid Tumors

A Multicenter, Open-label Phase I/II Clinical Study on the Safety, Tolerability, Pharmacokinetics and Efficacy of SHR-4298 Injection in Patients With Malignant Solid Tumors

This study is an open-label, multicenter Phase I/II clinical trial to evaluate the safety, tolerability and efficacy of SHR-4298 injection in patients with malignant solid tumors.

Study Overview

• Status: Not yet recruiting
• Conditions: Malignant Solid Tumors
• Intervention / Treatment: Drug: SHR-4298 Injection

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Lulu Yang; Phone Number: +86-0518-82342973; Email: lulu.yang.ly103@hengrui.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510032
      • The First Affiliated Hospital of Guangzhou Medical University
      • Principal Investigator: Chengzhi Zhou
      • Contact: Chengzhi Zhou; Phone Number: +86-13560351186; Email: doctorzcz@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Subjects must voluntarily agree to participate in the trial and sign a written informed consent form.
2. ECOG performance score of 0-1.
3. Life expectancy ≥ 3 months.
4. Have at least one measurable tumor lesion per RECIST v1.1.
5. Patients with recurrent or metastatic solid tumors confirmed by histopathology and not amenable to radical surgery or radical chemoradiotherapy.
6. Good level of organ function.
7. Provide archived or fresh tumor tissue for vendor test.

Exclusion Criteria:

1. Subjects with active central nervous system metastases or meningeal metastases.
2. Suffering from other malignant tumors within five years before the first use of the drug.
3. History of serious cardiovascular and cerebrovascular diseases.
4. Clinically significant bleeding symptoms occurred within 3 months before the first dose of study drug.
5. Subjects with uncontrolled tumor-related pain.
6. Clinically uncontrollable third space effusion or third space effusion requiring intervention within 7 days before the first study treatment.
7. Subjects who had a serious infection within 4 weeks before the first dose of the drug.
8. History of immunodeficiency, including a positive HIV test or active hepatitis B or C.
9. Subjects who received > 30 Gy of chest radiotherapy within 24 weeks before the first dose of the drug, subjects who received > 30 Gy of non-chest radiotherapy within 4 weeks before the first dose of the drug, and subjects who received ≤ 30 Gy of palliative radiation within 14 days before the first dose of the drug.
10. Underwent major organ surgery within 28 days before the first dose of the drug.
11. Those who are known to be allergic to any ingredients or excipients of SHR-4298 product.
12. Administered a live attenuated vaccine within 28 days before the first dose.
13. Female subjects who are pregnant, breastfeeding, or planning to become pregnant during the study.
14. Per the investigator's judgment, there are any other circumstances that may increase the risk of participating in the study, interfere with the study results, or make participation in the study inappropriate.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SHR-4298 Group	Drug: SHR-4298 Injection; SHR-4298 injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence and severity of adverse events (AEs).	Approximately 18 months.
Incidence and severity of serious adverse events (SAEs).	Approximately 18 months.
Maximum Tolerated Dose (MTD).	Approximately 18 months.
Maximum Applicable Dose (MAD).	Approximately 18 months.
Recommended Phase 2 Dose (RP2D).	Approximately 18 months.
Dose-limiting toxicity (DLT).	Approximately 18 months.

Secondary Outcome Measures

Outcome Measure	Time Frame
Overall response rate (ORR).	Approximately 18 months.
Duration of response (DoR).	Approximately 18 months.
Disease control rate (DCR).	Approximately 18 months.
Progression-free survival (PFS).	Approximately 18 months.
Overall survival (OS).	Approximately 5 years after the last subject enrolled.

Collaborators and Investigators

• Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2025
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): November 1, 2028

Study Registration Dates

• First Submitted: November 13, 2025
• First Submitted That Met QC Criteria: November 13, 2025
• First Posted (Actual): November 17, 2025

Study Record Updates

• Last Update Posted (Actual): November 17, 2025
• Last Update Submitted That Met QC Criteria: November 13, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: SHR-4298-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No