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

NCT07229612 | Not Yet Recruiting Phase 1

• 1 other identifier: SHR-4298-101
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Malignant Solid Tumors

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (5)

• 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.

Study Arms (1)

SHR-4298 Group

EXPERIMENTAL

Drug: SHR-4298 Injection

Interventions

SHR-4298 Injection DRUG

SHR-4298 injection.

SHR-4298 Group

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• Subjects with active central nervous system metastases or meningeal metastases.
• Suffering from other malignant tumors within five years before the first use of the drug.
• History of serious cardiovascular and cerebrovascular diseases.
• Clinically significant bleeding symptoms occurred within 3 months before the first dose of study drug.
• Subjects with uncontrolled tumor-related pain.
• Clinically uncontrollable third space effusion or third space effusion requiring intervention within 7 days before the first study treatment.
• Subjects who had a serious infection within 4 weeks before the first dose of the drug.
• History of immunodeficiency, including a positive HIV test or active hepatitis B or C.
• 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.
• Underwent major organ surgery within 28 days before the first dose of the drug.
• Those who are known to be allergic to any ingredients or excipients of SHR-4298 product.
• Administered a live attenuated vaccine within 28 days before the first dose.
• Female subjects who are pregnant, breastfeeding, or planning to become pregnant during the study.
• 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.

Sponsors & Collaborators

• Suzhou Suncadia Biopharmaceuticals Co., Ltd.: lead

Study Sites (1)

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510032, China

Location

Central Study Contacts

Lulu Yang

CONTACT

+86-0518-82342973; lulu.yang.ly103@hengrui.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2025
• First Posted: November 17, 2025
• Study Start: November 1, 2025
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): November 1, 2028
• Last Updated: November 17, 2025

Record last verified: 2025-11

Locations

CN (1)