SHR-4298 Injection for Malignant Solid Tumors: a Phase I/II study

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This open-label, multicenter Phase I/II trial enrolls patients with unresectable or recurrent malignant solid tumors to assess safety, tolerability, and preliminary efficacy of SHR-4298 injections. Participants need measurable disease, adequate organ function, and an ECOG performance status of 0–1. The study includes sequential assessment of dose tolerance and anti-tumor activity, with tissue samples required for analysis. Locations are the First Affiliated Hospital of Guangzhou Medical University in Guangzhou, China, and the sponsor is Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Why it matters

Who can join: the full rules

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.

Where it's running

• The First Affiliated Hospital of Guangzhou Medical University
  Guangzhou, Guangdong, China Recruiting

Study contacts

• Study coordinator: Lulu Yang
• Email: lulu.yang.ly103@hengrui.com
• Phone: +86-0518-82342973

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• CAIX-targeted PET/CT imaging in solid tumors

  Researchers are testing a CAIX-targeted PET/CT imaging agent to see if it detects and reflects CAIX levels in solid tumors like clear cell renal cell carcinoma, NSCLC, and breast cancer.

  Recruiting Zhongnan Hospital · Wuhan, Hubei · NCT07833085

• TAK-505 treatment for adults with advanced solid tumors

  This trial will test TAK-505, an experimental drug, in adults with locally advanced or metastatic solid tumors (such as stomach, colorectal, non-small cell lung, and head and neck cancers) who have limited standard treatment options.

  Recruiting at 13 sites Phase 1/2 Takeda · Orange, California and 14 other locations · NCT07436728

• SHR-7787 combined with other anti-cancer drugs for malignant solid tumors

  This study will test whether giving SHR-7787 together with other anti-cancer medicines is safe and helps people with unresectable malignant solid tumors.

  Recruiting at 2 sites Phase 2 Shanghai Hengrui Pharmaceutical Co., Ltd. · Wuhan, Hubei and 1 other locations · NCT07268040

• SHR-4849 combined with other cancer drugs for malignant solid tumors

  This study will test whether adding SHR-4849 to other cancer drugs is safe and can help adults with malignant solid tumors.

  Recruiting Phase 2 Suzhou Suncadia Biopharmaceuticals Co., Ltd. · Jinan, Shandong · NCT07028281

• JCXH-211 injections with anti-PD-1 therapy for malignant solid tumors

  This study tests whether injecting JCXH-211 directly into tumors, together with an anti-PD-1 medicine, is safe and tolerable in adults with malignant solid tumors.

  Recruiting Phase 1/2 Immorna Biotherapeutics, Inc. · Guangzhou, Guangdong · NCT06781125

• Evaluating SHR-1681 for patients with advanced solid tumors

  This study is testing a new injection called SHR-1681 to see if it can safely help people with advanced solid tumors that haven't responded to other treatments.

  Recruiting Phase 1/2 Suzhou Suncadia Biopharmaceuticals Co., Ltd. · Shanghai, Shanghai Municipality · NCT06737731

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.