A Trial of SHR-7782 for Treatment of Advanced Malignant Tumors
NCT07123129
Phase
Phase 1
Recruitment status
Recruiting
Participants
Lead sponsor
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Start date
2025-08-28
Number of sites
- Summary
- The main objective of this study is to evaluate the effectiveness and safety of SHR-7782 for participants with advanced malignant cancer.
- Short title
- A Trial of SHR-7782 for Treatment of Advanced Malignant Tumors
- Official title
- An Open-label, Multicenter Phase I Clinical Study of SHR-7782 Injection in the Treatment of Advanced Malignant Cancer
- Control arm
- Open label
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Completion date
- 2027-12-01
- First posted
- 2025-08-14
- Registry last updated
- 2026-01-30
- Primary completion date
- 2026-12-01
- Start date
- 2025-08-28
- Participants
- Participant count basis
- Estimated
- Planned participants
- Protocol amendments
- Number of sites
- Registry sponsor category
- Industry
- Lead sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT07123129
- ClinicalTrials.gov ID
- NCT07123129
- Registry record
- Open registry record
- Allocation
- Not applicable
- Model
- Single group
- Purpose
- Treatment
- Masking
- No masking
Sources for study design
Dose Limited Toxicity (DLT)
Timeframe: Up to 21 days.
Maximum Tolerated Dose (MTD)
Timeframe: Up to 6 months.
Recommended Phase II Dose (RP2D)
Timeframe: Up to 21 days.
Objective Response Rate (ORR) assessed by the investigator according to RECIST 1.1 criteria
Timeframe: Up to approximately 24 months.
Duration of Response (DoR) assessed by the investigator according to RECIST 1.1 criteria
Timeframe: Up to approximately 24 months.
Disease Control Rate (DCR) assessed by the investigator according to RECIST 1.1 criteria
Timeframe: Up to approximately 24 months.
Progression Free Survival (PFS) assessed by the investigator according to RECIST 1.1 criteria
Timeframe: Up to approximately 24 months.
Overall Survival (OS)
Timeframe: Up to approximately 24 months.
Sources for outcomes
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 18 Years
- Maximum age
- 75 Years
- Healthy volunteers
- No
- 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.
- 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.
Sources for eligibility
- Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical CollegeBeijing, ChinaRecruiting
- Zhejiang Cancer HospitalHangzhou, ChinaRecruiting
Sources for sites