A Trial of SHR-7782 for Treatment of Advanced Malignant Tumors

Not Applicable

Not yet recruiting

• Conditions: Advanced Malignancy
• Interventions: Drug: SHR-7782 Injection

• Registration Number: NCT07123129
• Lead Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Brief Summary

The main objective of this study is to evaluate the effectiveness and safety of SHR-7782 for participants with advanced malignant cancer.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-08
• Study Start: 2025-08-01
• Study First Submitted: 2025-08-07
• Study First Submitted QC: 2025-08-07
• Last Update Submitted: 2025-08-07
• Study First Posted: 2025-08-14
• Last Update Posted: 2025-08-14
• Primary Completion: 2026-12
• Study Completion: 2027-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SHR-7782 Group	SHR-7782 Injection	-

Primary Outcome Measures

Name	Time	Method
Dose Limited Toxicity (DLT)	Up to 21 days.
Recommended Phase II Dose (RP2D)	Up to 21 days.
Maximum Tolerated Dose (DLT)	Up to 6 months.

Secondary Outcome Measures

Name	Time	Method
Objective Response Rate (ORR) assessed by the investigator according to RECIST 1.1 criteria	Up to approximately 24 months.
Duration of Response (DoR) assessed by the investigator according to RECIST 1.1 criteria	Up to approximately 24 months.
Disease Control Rate (DCR) assessed by the investigator according to RECIST 1.1 criteria	Up to approximately 24 months.
Progression Free Survival (PFS) assessed by the investigator according to RECIST 1.1 criteria	Up to approximately 24 months.
Overall Survival (OS)	Up to approximately 24 months.

Trial Locations

Locations (2)

Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College; 🇨🇳 Beijing, Beijing, China

Zhejiang Cancer Hospital; 🇨🇳 Hangzhou, Zhejiang, China