Clinical trial NCT05819684: A Study of SHR-4602 in Subjects With Advanced Malignant Solid Tumors
Official title: A Phase I Multi-Center, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of SHR-4602 in HER2 Expressing or Mutated Advanced Malignant Solid Tumor Subjects
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Advanced Solid Tumor
Lead sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-04-19
Enrollment: 133
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: 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. Include three stages: dose escalation, PK expansion, and efficacy expansion.
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. 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;
2. At least one measurable lesion based on RECIST v1.1 criteria;
3. ECOG PS score: 0-1 points;
4. Expected survival period ≥ 3 months;
5. Adequate organ function;
6. Must take one medically approved contraceptive measure;
7. Patients voluntarily joined the study and signed informed consent.

Exclusion Criteria:

1. Patients with known CNS metastasis or hepatic encephalopathy;
2. Suffering from peripheral neuropathy;
3. 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;
4. Patients with any active, known or suspected autoimmune disorder;
5. With known severe allergic reactions to any other monoclonal antibodies;
6. 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;
7. Patients with other malignancies currently or within the past 5 years;
8. Uncontrolled cardiac diseases or symptoms;
9. With known hereditary or acquired bleeding (e.g., coagulopathy) or a tendency to clot (e.g., hemophiliacs);
10. Patients with other potential factors that may affect the study results.

Primary outcomes:
measure: Incidence and severity of adverse events (AEs)
timeFrame: From Day 1 to 90 days after last dose
measure: Maximum tolerated dose (MTD)
timeFrame: From Day 1 to 21 days after first dose
measure: Dose Limiting Toxicities (DLT)
timeFrame: From Day 1 to 21 days after first dose
measure: Recommended Phase 2 dose (RP2D)
timeFrame: From Day 1 to 90 days after last dose
Secondary outcomes:
measure: PK parameters of SHR-4602 for Injection: Cmax
timeFrame: the date of first dose to 30 days after last dose
measure: PK parameters of SHR-4602 for Injection: AUC0-t
timeFrame: the date of first dose to 30 days after last dose
measure: PK parameters of SHR-4602 for Injection: Tmax
timeFrame: the date of first dose to 30 days after last dose
measure: PK parameters of SHR-4602 for Injection: T1/2
timeFrame: the date of first dose to 30 days after last dose
measure: ADA
timeFrame: the date of first dose up to 90 days after last dose
measure: ORR
timeFrame: the date of first dose up to 90 days after last dose
measure: DCR
timeFrame: the date of first dose up to 90 days after last dose
measure: DOR
timeFrame: the date of first dose up to 90 days after last dose
measure: PFS
timeFrame: the date of first dose up to 90 days after last dose
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
state: Guangdong
Study officials:
References: