SHR-7787 injection: Firstly Dose Escalation and Dose Expansion of SHR-7787 injection monotherapy should be conducted.
Study summary
The study is being conducted to evaluate safety, tolerability, pharmacokinetics and preliminary efficacy of SHR-7787 injection monotherapy for patients with advanced solid tumors. To explore the reasonable dosage of SHR-7787 injection monotherapy for patients with advanced solid tumors.
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria:
1. Ability to understand and voluntarily agrees to participate by giving written informed consent for the study;
2. Patients with unresectable recurrent or metastatic solid tumors;
3. There is at least one lesion could be measured;
4. An Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1;
5. Adequate organ functions as defined;
6. Life expectancy ≥3 months.
Exclusion Criteria:
1. Patients with known active central nervous system (CNS) metastases;
2. Subjects who had other malignancy in five years before the first dose;
3. Patients with tumor-related pain that cannot be controlled as determined;
4. Patients with serious cardiovascular and cerebrovascular diseases;
5. Uncontrollable third-space effusion, such as pleural effusion, pericardial effusion or peritoneal effusion;
6. Patients with Severe infections;
7. History of immunodeficiency;
8. History of autoimmune diseases;
9. Unresolved CTCAE Grade \>1 toxicity attributed to any prior anti-tumor therapy
10. Active infection;
11. Pregnant or nursing women;
12. Known history of serious allergic reactions to the investigational product or its main ingredients.
Primary outcome measure(s)
Maximum tolerated dose — first dose of study medication up to 21 days The Maximum tolerated dose of SHR-7787 injection monotherapy
Recommended phase II dose — first dose of study medication up to 21 days The Recommended phase II dose of SHR-7787 injection monotherapy
Incidence and severity of adverse events (AEs)/serious adverse events (SAEs) — from signature completion of ICF to 60 days after the last dose or to the beginning of the new anti-cancer therapy, whichever came first, assessed up to 24 weeks Incidence and severity of adverse events (AEs)/serious adverse events (SAEs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Incidence of Dose Limited Toxicity (DLT) — from first dose to 4 weeks Incidence of Dose Limited Toxicity (DLT) described in the protocol
Trial sites (1)
Facility
City
Region
Status
Shanghai Pulmonary Hospital
Shanghai
Shanghai Municipality
Recruiting
More Shanghai Hengrui Pharmaceutical Co., Ltd. trials in China
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.
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