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

Suzhou Suncadia Biopharmaceuticals

Status and phase: Enrolling; Phase 1

Conditions: Advanced Malignancy

Treatments: Drug: SHR-7782 Injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT07123129

SHR-7782-101

Details and patient eligibility

About

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

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 1 patient group

SHR-7782 Group

Experimental group

Treatment:

Drug: SHR-7782 Injection