Advanced Solid Tumors
Conditions
Brief summary
This is a dose-escalation and dose-expansion Phase 1 trial to evaluate the safety and tolerability of SHR-7367 in subjects with advanced solid tumors.
Interventions
DRUGSHR-7367
The study was divided into three phases, the dose escalation phase and the dose extension phase and therapeutic effect extension of SHR-7367 in subjects with advanced malignant tumors.
Sponsors
Shanghai Hengrui Pharmaceutical Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
The study was divided into three phases, the dose escalation phase and the dose extension phase and therapeutic effect extension of SHR-7367 in subjects with advanced malignant tumors.
Eligibility
Sex/Gender
ALL
Age
18 Years to 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. Male or female aged ≥18 years and ≤75 years at the time of signing the ICF; 3. Histopathologically or cytologically documented advanced or metastatic malignancies; 4. At least 1 measurable lesion conforming to RECIST 1.1 criteria; 5. An Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1; 6. Female and male patients of reproductive potential must agree to use highly effective contraception.
Exclusion criteria
1. Any immunostimulants administered within 4 weeks; 2. Systemic anti-tumor therapy within 4 weeks; 3. Any investigational cancer therapy administered within 4 weeks; 4. Surgical procedures requiring general anesthesia within 4 weeks; 5. History of autoimmune diseases; 6. History of immunodeficiency; 7. Severe infections within 2 weeks prior to the first study treatment; 8. Clinically significant cardiovascular condition; 9. Prior malignancy (other than current malignant tumor) within 5 ears before the first dose of study treatment; 10. Known history of serious allergic reactions to the investigational product or its main ingredients.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dose-limiting toxicities (DLTs) | Up to 3 weeks | Number of participants with DLTs |
| Recommended phase II dose | first dose of study medication up to 21 days | The Recommended phase II dose of SHR-7367 injection |
| Incidence and severity of adverse events (AEs)/serious adverse events (SAEs) | Up to 12 months | • Incidence and severity of adverse events (AEs)/serious adverse events (SAEs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0 |
Secondary
| Measure | Time frame |
|---|---|
| Tumor response using RECIST 1.1 | From first dose to disease progression or death, whichever comes first, up to 12 months |
| peak time (Tmax) | Up to 12 months |
| peak concentration (Cmax) | Up to 12 months |
| area under curve from 0 to the last measurable concentration time point t (AUC0-t), | Up to 12 months |
| area under curve from 0 to infinity (AUC0-∞) | Up to 12 months |
| elimination half-life (t1/2) | Up to 12 months |
| clearance rate (CL) | Up to 12 months |
| steady-state apparent volume of distribution (Vss) | Up to 12 months |
| steady-state peak concentration (Cmax, ss) | Up to 12 months |
| steady-state valley concentration (Ctrough, ss) | Up to 12 months |
| accumulation ratio (Rac) | Up to 12 months |
| percentage of activated B lymphocyte subsets in peripheral blood | Up to 12 months |
| Immunogenicity index: drug-resistant antibody (ADA) | Up to 12 months |
| Efficacy endpoints: Objective response rate (ORR) | Up to 12 months |
Countries
China
Outcome results
None listed