A Trial of SHR-7367 in Subjects With Advanced Solid Tumors
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: SHR-7367
|
Drug: SHR-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.
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Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Ability to understand and voluntarily agrees to participate by giving written informed consent for the study;
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Male or female aged ≥18 years and ≤75 years at the time of signing the ICF;
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Histopathologically or cytologically documented advanced or metastatic malignancies;
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At least 1 measurable lesion conforming to RECIST 1.1 criteria;
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An Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1;
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Female and male patients of reproductive potential must agree to use highly effective contraception.
Exclusion Criteria:
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Any immunostimulants administered within 4 weeks;
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Systemic anti-tumor therapy within 4 weeks;
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Any investigational cancer therapy administered within 4 weeks;
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Surgical procedures requiring general anesthesia within 4 weeks;
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History of autoimmune diseases;
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History of immunodeficiency;
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Severe infections within 2 weeks prior to the first study treatment;
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Clinically significant cardiovascular condition;
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Prior malignancy (other than current malignant tumor) within 5 ears before the first dose of study treatment;
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Known history of serious allergic reactions to the investigational product or its main ingredients.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Shanghai Hengrui Pharmaceutical Co., Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SHR-7367-I-101