Recruiting NCT07123129
A Trial of SHR-7782 for Treatment of Advanced Malignant Tumors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SHR-7782 Injection.
- Who it may be relevant to
- Registry conditions: Advanced Malignancy. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
An Open-label, Multicenter Phase I Clinical Study of SHR-7782 Injection in the Treatment of Advanced Malignant Cancer
Overview
The main objective of this study is to evaluate the effectiveness and safety of SHR-7782 for participants with advanced malignant cancer.
Interventions
- Drug SHR-7782 Injection
SHR-7782 injection.
Primary outcome measures
- Dose Limited Toxicity (DLT) [Time frame: Up to 21 days.]
- Maximum Tolerated Dose (MTD) [Time frame: Up to 6 months.]
- Recommended Phase II Dose (RP2D) [Time frame: Up to 21 days.]
Secondary outcome measures (5)
- Objective Response Rate (ORR) assessed by the investigator according to RECIST 1.1 criteria [Time frame: Up to approximately 24 months.]
- Duration of Response (DoR) assessed by the investigator according to RECIST 1.1 criteria [Time frame: Up to approximately 24 months.]
- Disease Control Rate (DCR) assessed by the investigator according to RECIST 1.1 criteria [Time frame: Up to approximately 24 months.]
- Progression Free Survival (PFS) assessed by the investigator according to RECIST 1.1 criteria [Time frame: Up to approximately 24 months.]
- Overall Survival (OS) [Time frame: Up to approximately 24 months.]
Eligibility criteria
Inclusion criteria
- Participate in the study voluntarily, sign the informed consent form.
- Subjects were able to provide primary or metastatic cancer samples.
- At least one measurable lesion (RECIST version 1.1).
- ECOG 0\~1.
- With adequate organ functions.
- Expected survival time ≥ 12 weeks.
Exclusion criteria
- With untreated brain metastasis or active central nervous system tumor metastases.
- Imaging shows that the tumor invades large blood vessels or has unclear boundaries with blood vessels.
- Patients with other malignant tumors in the past or at the same time.
- Patients with clinical symptoms, uncontrolled, or moderate or above pleural effusion, pericardial effusion, or peritoneal effusion.
- Patients with a history of interstitial pneumonia or interstitial lung disease or non-infectious pneumonia requiring steroid treatment.
- With poorly controlled or severe cardiovascular disease.
- Bleeding events of NCI-CTCAE v5.0 grade ≥ 2 occurred within 1 month before the first medication.
- Subjects who had a serious infection within 1 month before the first medication.
- History of immunodeficiency.
- Known allergy to any component of the SHR-7782 product.
- According to the researcher's judgment, there are other factors that may affect the research results or cause the research to be terminated midway.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 2 centers
- Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College — Beijing
- Zhejiang Cancer Hospital — Hangzhou
Identifiers
NCT: NCT07123129 · SHR-7782-101