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

Suzhou Suncadia Biopharmaceuticals Co., Ltd.1 site in 1 country133 target enrollmentApril 18, 2023

ConditionsAdvanced Solid Tumor

InterventionsSHR-4602 for injection

DrugsSHR-4602 for injection

Overview

Phase: Phase 1
Intervention: SHR-4602 for injection
Conditions: Advanced Solid Tumor
Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Enrollment: 133
Locations: 1
Primary Endpoint: Dose Limiting Toxicities (DLT)
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

April 18, 2023

End Date

May 30, 2026

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

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.

Arms & Interventions

Part 1: Dose escalation

Intervention: SHR-4602 for injection

Part 2: PK expansion

Intervention: SHR-4602 for injection

Part 3: efficacy expansion

Intervention: SHR-4602 for injection

Outcomes

Primary Outcomes

Dose Limiting Toxicities (DLT)

Time Frame: From Day 1 to 21 days after first dose

Maximum tolerated dose (MTD)

Time Frame: From Day 1 to 21 days after first dose

Incidence and severity of adverse events (AEs)

Time Frame: From Day 1 to 90 days after last dose

Recommended Phase 2 dose (RP2D)

Time Frame: From Day 1 to 90 days after last dose

Secondary Outcomes

DCR(the date of first dose up to 90 days after last dose)
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)
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)
DOR(the date of first dose up to 90 days after last dose)
PFS(the date of first dose up to 90 days after last dose)