A Phase I/II, Open Label, Multicenter Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of SHR-7787 in Patients With Advanced Solid Tumors
Overview
- Phase
- Phase 1
- Intervention
- SHR-7787 injection
- Conditions
- Advanced Solid Tumors
- Sponsor
- Shanghai Hengrui Pharmaceutical Co., Ltd.
- Enrollment
- 201
- Locations
- 1
- Primary Endpoint
- Maximum tolerated dose
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Ability to understand and voluntarily agrees to participate by giving written informed consent for the study;
- •Patients with unresectable recurrent or metastatic solid tumors;
- •There is at least one lesion could be measured;
- •An Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1;
- •Adequate organ functions as defined;
- •Life expectancy ≥3 months.
Exclusion Criteria
- •Patients with known active central nervous system (CNS) metastases;
- •Subjects who had other malignancy in five years before the first dose;
- •Patients with tumor-related pain that cannot be controlled as determined;
- •Patients with serious cardiovascular and cerebrovascular diseases;
- •Uncontrollable third-space effusion, such as pleural effusion, pericardial effusion or peritoneal effusion;
- •Patients with Severe infections;
- •History of immunodeficiency;
- •History of autoimmune diseases;
- •Unresolved CTCAE Grade \>1 toxicity attributed to any prior anti-tumor therapy
- •Active infection;
Arms & Interventions
Single Group: SHR-7787 injection
Intervention: SHR-7787 injection
Outcomes
Primary Outcomes
Maximum tolerated dose
Time Frame: first dose of study medication up to 21 days
The Maximum tolerated dose of SHR-7787 injection monotherapy
Recommended phase II dose
Time Frame: 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)
Time Frame: 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)
Time Frame: from first dose to 4 weeks
Incidence of Dose Limited Toxicity (DLT) described in the protocol
Secondary Outcomes
- Tmax(predose, 8 h (hours), 24h, 48h, 72h, 168h post-dose)
- Cmax(predose, 8 h (hours), 24h, 48h, 72h, 168h post-dose)
- AUC0-t(predose, 8 h (hours), 24h, 48h, 72h, 168h post-dose)
- t1/2(predose, 8 h (hours), 24h, 48h, 72h, 168h post-dose)
- ADA(0.5 hour before first dose through study completion, an average of 1 year)
- ORR(from the date of the first dose to the date of disease progression evaluated based on RECIST v1.1 criteria, death, lost to follow-up, voluntary withdrawal, or initiation of other anti-tumor treatment, whichever occurs first, assessed up to 6 months)