A Study of SHR-4602 in Subjects With Advanced Malignant Solid Tumors

Advanced Solid Tumor Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05819684
• Other study ID #: SHR-4602-I-101
• Status: Recruiting
• Phase: Phase 1
• Start date: April 18, 2023
• Est. completion date: May 30, 2026

Study information

• Verified date: June 2024
• Source: Suzhou Suncadia Biopharmaceuticals Co., Ltd.
• Contact: Xin Shi
• Phone: 0518-82342973
• Email: xin.shi.xs3[@]hengrui.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 133
• Est. completion date: May 30, 2026
• Est. primary completion date: May 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Solid Tumor
• Neoplasms

Intervention

Drug:
• SHR-4602 for injection
be administered via intravenous (IV) infusion

Locations

Country	Name	City	State
China	Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence and severity of adverse events (AEs)		From Day 1 to 90 days after last dose
Primary	Maximum tolerated dose (MTD)		From Day 1 to 21 days after first dose
Primary	Dose Limiting Toxicities (DLT)		From Day 1 to 21 days after first dose
Primary	Recommended Phase 2 dose (RP2D)		From Day 1 to 90 days after last dose
Secondary	PK parameters of SHR-4602 for Injection: Cmax		the date of first dose to 30 days after last dose
Secondary	PK parameters of SHR-4602 for Injection: AUC0-t		the date of first dose to 30 days after last dose
Secondary	PK parameters of SHR-4602 for Injection: Tmax		the date of first dose to 30 days after last dose
Secondary	PK parameters of SHR-4602 for Injection: T1/2		the date of first dose to 30 days after last dose
Secondary	ADA	Anti-drug antibody, Immunogenicity of SHR-4602 for Injection	the date of first dose up to 90 days after last dose
Secondary	ORR	Objective Response Rate, Efficacy endpoints of SHR-4602 for Injection,As assessed by RECIST v1.1	the date of first dose up to 90 days after last dose
Secondary	DCR	Disease control rate, Efficacy endpoints of SHR-4602 for Injection,As assessed by RECIST v1.1	the date of first dose up to 90 days after last dose
Secondary	DOR	Duration of response, Efficacy endpoints of SHR-4602 for Injection,As assessed by RECIST v1.1	the date of first dose up to 90 days after last dose
Secondary	PFS	Progression Free Survival, Efficacy endpoints of SHR-4602 for Injection,As assessed by RECIST v1.1	the date of first dose up to 90 days after last dose