A Trial of SHR-7787 Injection Combined With Other Anti-tumor Drugs in Patients With Malignant Solid Tumors
A Multicenter, Open-label Phase II Clinical Study of SHR-7787 Combined With Other Antitumor Drugs in Patients With Advanced Solid Tumors
1 other identifier
interventional
400
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Dec 2025
Typical duration for phase_2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 24, 2025
CompletedFirst Posted
Study publicly available on registry
December 5, 2025
CompletedStudy Start
First participant enrolled
December 23, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2028
January 12, 2026
January 1, 2026
2.9 years
November 24, 2025
January 8, 2026
Conditions
Outcome Measures
Primary Outcomes (6)
The Recommended phase II dose of SHR-7787 injection monotherapy (stage I)
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)
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)
About 1 year after study initiation.
Incidence of Dose Limited Toxicity (DLT) described in the protocol (stage I)
About 1 year after study initiation.
Objective response rate (ORR) (stage II)
Expected to be two years after the start of the study.
Progress Free Survival (FPS) (stage II)
Expected to be two years after the start of the study.
Secondary Outcomes (5)
Objective response rate (ORR)
About 1 year.
Duration of Response (DoR)
About 1 year.
Disease Control Rate (DCR)
About 1 year.
Progress Free Survival (PFS)
About 1 year.
Overall Survival (OS)
About 1 year.
Study Arms (8)
SHR-7787 combined with SHR-1316
EXPERIMENTALSHR-7787 injection combined with SHR-1316 injection.
SHR-7787 combined with SHR-4849
EXPERIMENTALSHR-7787 injection combined with SHR-4849 injection.
SHR-7787 combined with etoposide and carboplatin/cisplatin
EXPERIMENTALSHR-7787 injection combined with etoposide and carboplatin/cisplatin injection.
SHR-7787 combined with SHR-1316, etoposide, carboplatin/cisplatin
EXPERIMENTALSHR-7787 injection combined with SHR-1316, etoposide, carboplatin/cisplatin injection.
SHR-7787 combined with SHR-4849 and SHR-1316
EXPERIMENTALSHR-7787 injection combined with SHR-4849 and SHR-1316 injection.
SHR-7787 combined with SHR-1316 and BP102
EXPERIMENTALSHR-7787 injection combined with SHR-1316 and BP102 injection.
SHR-7787 combined with SHR-4849 and BP102
EXPERIMENTALSHR-7787 injection combined with SHR-4849 and BP102 injection.
SHR-7787 combined with SHR-4849, SHR-1316 and carboplatin/cisplatin
EXPERIMENTALSHR-7787 injection combined with SHR-4849, SHR-1316 and carboplatin/cisplatin injection.
Interventions
SHR-1316 Injection.
SHR-4849 Injection.
Etoposide Injection.
Carboplatin Injection.
Cisplatin Injection.
BP102 Injection.
SHR-7787 Injection.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science & Technology
Wuhan, Hubei, 430030, China
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, 200433, China
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 24, 2025
First Posted
December 5, 2025
Study Start
December 23, 2025
Primary Completion (Estimated)
December 1, 2028
Study Completion (Estimated)
December 1, 2028
Last Updated
January 12, 2026
Record last verified: 2026-01