SHR-7782 injection for advanced malignant tumors

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 phase 1 interventional trial administers SHR-7782 injections to adults with advanced malignant tumors to characterize safety, tolerability, and preliminary anti-tumor activity across dose levels. Participants must have at least one measurable lesion by RECIST 1.1, ECOG performance status 0–1, adequate organ function, an expected survival of at least 12 weeks, and be able to provide tumor samples. Key exclusion criteria include untreated brain metastases, active interstitial lung disease or history of steroid-requiring non-infectious pneumonitis, uncontrolled effusions, recent significant bleeding, concurrent other malignancies, and serious cardiovascular disease. The trial is sponsored by Suzhou Suncadia Biopharmaceuticals and is conducted at cancer centers in Beijing and Hangzhou, China.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Participate in the study voluntarily, sign the informed consent form.
2. Subjects were able to provide primary or metastatic cancer samples.
3. At least one measurable lesion (RECIST version 1.1).
4. ECOG 0\~1.
5. With adequate organ functions.
6. Expected survival time ≥ 12 weeks.

Exclusion Criteria:

1. With untreated brain metastasis or active central nervous system tumor metastases.
2. Imaging shows that the tumor invades large blood vessels or has unclear boundaries with blood vessels.
3. Patients with other malignant tumors in the past or at the same time.
4. Patients with clinical symptoms, uncontrolled, or moderate or above pleural effusion, pericardial effusion, or peritoneal effusion.
5. Patients with a history of interstitial pneumonia or interstitial lung disease or non-infectious pneumonia requiring steroid treatment.
6. With poorly controlled or severe cardiovascular disease.
7. Bleeding events of NCI-CTCAE v5.0 grade ≥ 2 occurred within 1 month before the first medication.
8. Subjects who had a serious infection within 1 month before the first medication.
9. History of immunodeficiency.
10. Known allergy to any component of the SHR-7782 product.
11. According to the researcher's judgment, there are other factors that may affect the research results or cause the research to be terminated midway.

Where it's running

• Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
  Beijing, Beijing Municipality, China Recruiting
• Zhejiang Cancer Hospital
  Hangzhou, Zhejiang, China Recruiting

Study contacts

• Study coordinator: Zhifei Lin
• Email: zhifei.lin.zl3@hengrui.com
• Phone: +86-0518-82342973

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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.