A Study of SHR-4602 in Subjects With Advanced Malignant Solid Tumors
Phase 1
Recruiting
- Conditions
- Advanced Solid Tumor
- Interventions
- Drug: SHR-4602 for injection
- Registration Number
- NCT05819684
- Lead Sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.
- Brief Summary
This is an open-label, three-part study to evaluate the safety, tolerability, pharmacokinetics and immunogenicity of SHR-4602 and preliminary anti-tumor efficacy in HER2 expressing or mutated advanced malignant solid tumor subjects.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 133
Inclusion Criteria
- Advanced/unresectable or metastatic solid tumor with HER2 expression or mutation that is refractory to or intolerable with standard treatment, or for which no standard treatment is available;
- At least one measurable lesion based on RECIST v1.1 criteria;
- ECOG PS score: 0-1 points;
- Expected survival period ≥ 3 months;
- Adequate organ function;
- Must take one medically approved contraceptive measure;
- Patients voluntarily joined the study and signed informed consent.
Exclusion Criteria
- Patients with known CNS metastasis or hepatic encephalopathy;
- Suffering from peripheral neuropathy;
- History of clinically significant lung diseases (e.g., interstitial pneumonia, pneumonitis, pulmonary fibrosis, and severe radiation pneumonitis) or suspected to have these diseases by imaging at screening period;
- Patients with any active, known or suspected autoimmune disorder;
- With known severe allergic reactions to any other monoclonal antibodies;
- Patients with symptomatic ascites or pleural effusion requiring paracentesis and drainage, or patients who have undergone ascites or pleural effusion drainage within 2 weeks before the first dose;
- Patients with other malignancies currently or within the past 5 years;
- Uncontrolled cardiac diseases or symptoms;
- With known hereditary or acquired bleeding (e.g., coagulopathy) or a tendency to clot (e.g., hemophiliacs);
- Patients with other potential factors that may affect the study results.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Part 1: Dose escalation SHR-4602 for injection - Part 2: PK expansion SHR-4602 for injection - Part 3: efficacy expansion SHR-4602 for injection -
- Primary Outcome Measures
Name Time Method Dose Limiting Toxicities (DLT) From Day 1 to 21 days after first dose Maximum tolerated dose (MTD) From Day 1 to 21 days after first dose Incidence and severity of adverse events (AEs) From Day 1 to 90 days after last dose Recommended Phase 2 dose (RP2D) From Day 1 to 90 days after last dose
- Secondary Outcome Measures
Name Time Method DCR the date of first dose up to 90 days after last dose Disease control rate, Efficacy endpoints of SHR-4602 for Injection，As assessed by RECIST v1.1
PK parameters of SHR-4602 for Injection: Cmax the date of first dose to 30 days after last dose PK parameters of SHR-4602 for Injection: AUC0-t the date of first dose to 30 days after last dose PK parameters of SHR-4602 for Injection: T1/2 the date of first dose to 30 days after last dose ADA the date of first dose up to 90 days after last dose Anti-drug antibody, Immunogenicity of SHR-4602 for Injection
PK parameters of SHR-4602 for Injection: Tmax the date of first dose to 30 days after last dose ORR the date of first dose up to 90 days after last dose Objective Response Rate, Efficacy endpoints of SHR-4602 for Injection，As assessed by RECIST v1.1
DOR the date of first dose up to 90 days after last dose Duration of response, Efficacy endpoints of SHR-4602 for Injection，As assessed by RECIST v1.1
PFS the date of first dose up to 90 days after last dose Progression Free Survival, Efficacy endpoints of SHR-4602 for Injection，As assessed by RECIST v1.1
Trial Locations
- Locations (1)
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
🇨🇳Guangzhou, Guangdong, China