Clinical Trials in China / NCT07268040
Recruiting
Phase 2
A Trial of SHR-7787 Injection Combined With Other Anti-tumor Drugs in Patients With Malignant Solid Tumors
NCT07268040 · tracked via the Priya Life Science China tracker
Condition(s) studied
Malignant Solid Tumors
Investigational drug(s) / intervention(s)
SHR-7787 Injection →SHR-1316 Injection →SHR-4849 Injection →Etoposide injection →Carboplatin injection →Cisplatin injection →BP102 Injection →
SHR-7787 Injection: SHR-7787 Injection.
SHR-1316 Injection: SHR-1316 Injection.
SHR-4849 Injection: SHR-4849 Injection.
Etoposide injection: Etoposide Injection.
Carboplatin injection: Carboplatin Injection.
Cisplatin injection: Cisplatin Injection.
BP102 Injection: BP102 Injection.
Study 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.
Eligibility
Inclusion Criteria:
1. Ability to understand and voluntarily agrees to participate by giving written informed consent for the study;
2. Patients with histologically or cytologically confirmed unresectable solid tumors;
3. At least one measurable lesion was identified per RECIST 1.1;
4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1;
5. Adequate organ functions as defined per protocol;
6. Minimum life expectancy of 3 months.
Exclusion Criteria:
1. Patients with known active central nervous system (CNS) metastases;
2. History of other malignancy within the past 5 years, with exceptions defined in the protocol;
3. Patients with uncontrolled cancer pain;
4. Patients with serious cardiovascular and/or cerebrovascular diseases;
5. Uncontrollable third-space effusion, such as pleural effusion, pericardial effusion or peritoneal effusion;
6. Patients with Severe infections within 4 weeks prior to the first dose;
7. Active pulmonary tuberculosis infection;
8. History of immunodeficiency;
9. History of autoimmune diseases;
10. The adverse events of previous antineoplastic therapy did not recover to CTCAE≤ grade 1;
11. Pregnant or nursing women, or planned to become pregnant during the study period;
12. Known allergic to any component of investigational drugs.
Primary outcome measure(s)
- 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.
Trial sites (2)
| Facility | City | Region | Status |
|---|---|---|---|
| Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science & Technology | Wuhan | Hubei | Recruiting |
| Shanghai Pulmonary Hospital | Shanghai | Shanghai Municipality | Recruiting |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07268040 on ClinicalTrials.gov ↗ ← All trials in China