A Trial of SHR-7787 Injection Combined With Other Anti-tumor Drugs in Patients With Malignant Solid Tumors
- Summary
- This study aims to evaluate the safety, tolerability and efficacy of SHR-7787 in combination with other anti-tumor drugs in patients with malignant solid tumors.
- Short title
- A Trial of SHR-7787 Injection Combined With Other Anti-tumor Drugs in Patients With Malignant Solid Tumors
- Official title
- A Multicenter, Open-label Phase II Clinical Study of SHR-7787 Combined With Other Antitumor Drugs in Patients With Advanced Solid Tumors
- Control arm
- Open label
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Completion date
- 2028-12-01
- First posted
- 2025-12-05
- Registry last updated
- 2026-01-12
- Primary completion date
- 2028-12-01
- Start date
- 2025-12-23
- Participants
- Participant count basis
- Estimated
- Planned participants
- Protocol amendments
- Number of sites
- Registry sponsor category
- Industry
- Lead sponsor
- Shanghai Hengrui Pharmaceutical Co., Ltd.
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT07268040
- ClinicalTrials.gov ID
- NCT07268040
- Registry record
- Open registry record
- Allocation
- Not randomised
- Model
- Parallel groups
- Purpose
- Treatment
- Masking
- No masking
The Recommended phase II dose of SHR-7787 injection monotherapy (stage I)
Timeframe: Expected to be two years after the start of the study.
Incidence and severity of adverse events (AEs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0 (stage I)
Timeframe: About 1 year after study initiation.
Incidence and severity of serious adverse events (SAEs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0 (stage I)
Timeframe: About 1 year after study initiation.
Incidence of Dose Limited Toxicity (DLT) described in the protocol (stage I)
Timeframe: About 1 year after study initiation.
Objective response rate (ORR) (stage II)
Timeframe: Expected to be two years after the start of the study.
Progress Free Survival (FPS) (stage II)
Timeframe: Expected to be two years after the start of the study.
Objective response rate (ORR)
Timeframe: About 1 year.
Duration of Response (DoR)
Timeframe: About 1 year.
Disease Control Rate (DCR)
Timeframe: About 1 year.
Progress Free Survival (PFS)
Timeframe: About 1 year.
Overall Survival (OS)
Timeframe: About 1 year.
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 18 Years
- Maximum age
- 75 Years
- Healthy volunteers
- No
- Ability to understand and voluntarily agrees to participate by giving written informed consent for the study;
- Patients with histologically or cytologically confirmed unresectable solid tumors;
- At least one measurable lesion was identified per RECIST 1.1;
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1;
- Adequate organ functions as defined per protocol;
- Minimum life expectancy of 3 months.
- Patients with known active central nervous system (CNS) metastases;
- History of other malignancy within the past 5 years, with exceptions defined in the protocol;
- Patients with uncontrolled cancer pain;
- Patients with serious cardiovascular and/or cerebrovascular diseases;
- Uncontrollable third-space effusion, such as pleural effusion, pericardial effusion or peritoneal effusion;
- Patients with Severe infections within 4 weeks prior to the first dose;
- Active pulmonary tuberculosis infection;
- History of immunodeficiency;
- History of autoimmune diseases;
- The adverse events of previous antineoplastic therapy did not recover to CTCAE≤ grade 1;
- Pregnant or nursing women, or planned to become pregnant during the study period;
- Known allergic to any component of investigational drugs.
- Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science & TechnologyWuhan, ChinaRecruiting
- Shanghai Pulmonary HospitalShanghai, ChinaRecruiting