SHR-7782 injection for advanced malignant tumors

An Open-label, Multicenter Phase I Clinical Study of SHR-7782 Injection in the Treatment of Advanced Malignant Cancer

This phase 1 trial will test SHR-7782 injections in adults with advanced malignant tumors who have measurable disease and adequate organ function.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd. (Industry-sponsored)
• Locations: 2 sites (Beijing, Beijing Municipality and 1 other locations)
• Trial ID: NCT07123129 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults with advanced malignant tumors who have measurable disease (RECIST 1.1), ECOG 0–1, adequate organ function, expected survival ≥12 weeks, and ability to provide tumor samples and attend study visits.

Not a fit: Patients with untreated brain metastases, active interstitial lung disease, uncontrolled pleural/pericardial/peritoneal effusions, recent significant bleeding, serious uncontrolled cardiovascular disease, other recent or concurrent malignancies, or inability to attend the Beijing or Hangzhou sites are unlikely to benefit from this trial.

Why it matters

Potential benefit: If SHR-7782 proves safe and active, it could offer a new treatment option for some patients with advanced malignant tumors.

How similar studies have performed: Phase 1 dose-escalation trials are a standard first step for new cancer drugs and some similar targeted agents have shown promise in early-phase trials, but SHR-7782's clinical benefit in humans has not yet been established.

Eligibility criteria

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 this trial is running

Beijing, Beijing Municipality and 1 other locations

• 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

Conditions Advanced Malignancy