Advanced Malignancy
Conditions
Brief summary
The main objective of this study is to evaluate the effectiveness and safety of SHR-7782 for participants with advanced malignant cancer.
Interventions
DRUGSHR-7782 Injection
SHR-7782 injection.
Sponsors
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose Limited Toxicity (DLT) | Up to 21 days. |
| Maximum Tolerated Dose (MTD) | Up to 6 months. |
| Recommended Phase II Dose (RP2D) | Up to 21 days. |
Secondary
| Measure | Time frame |
|---|---|
| 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. |
Countries
China
Contacts
CONTACTZhifei Lin
Outcome results
None listed