Clinical trial NCT05740202: A Trial of SHR-7367 in Subjects With Advanced Solid Tumors
Official title: A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacodynamics and Efficacy of SHR-7367 in Subjects With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Advanced Solid Tumors
Lead sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-02-22
Enrollment: 182
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Dose-limiting toxicities (DLTs)
timeFrame: Up to 3 weeks
measure: Recommended phase II dose
timeFrame: first dose of study medication up to 21 days
measure: Incidence and severity of adverse events (AEs)/serious adverse events (SAEs)
timeFrame: Up to 12 months
Secondary outcomes:
measure: Tumor response using RECIST 1.1
timeFrame: From first dose to disease progression or death, whichever comes first, up to 12 months
measure: peak time (Tmax)
timeFrame: Up to 12 months
measure: peak concentration (Cmax)
timeFrame: Up to 12 months
measure: area under curve from 0 to the last measurable concentration time point t (AUC0-t),
timeFrame: Up to 12 months
measure: area under curve from 0 to infinity (AUC0-∞)
timeFrame: Up to 12 months
measure: elimination half-life (t1/2)
timeFrame: Up to 12 months
measure: clearance rate (CL)
timeFrame: Up to 12 months
measure: steady-state apparent volume of distribution (Vss)
timeFrame: Up to 12 months
measure: steady-state peak concentration (Cmax, ss)
timeFrame: Up to 12 months
measure: steady-state valley concentration (Ctrough, ss)
timeFrame: Up to 12 months
measure: accumulation ratio (Rac)
timeFrame: Up to 12 months
measure: percentage of activated B lymphocyte subsets in peripheral blood
timeFrame: Up to 12 months
measure: Immunogenicity index: drug-resistant antibody (ADA)
timeFrame: Up to 12 months
measure: Efficacy endpoints: Objective response rate (ORR)
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute and Hospital
state: Tianjin
Study officials:
References: