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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Advanced Solid Tumor
• Intervention / Treatment: Drug: SHR-4602 for injection

• Study Type: Interventional
• Enrollment (Estimated): 133
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Xin Shi; Phone Number: 0518-82342973; Email: xin.shi.xs3@hengrui.com
• Study Contact Backup: Name: Wenjie Xin; Phone Number: 0518-82342973; Email: wenjie.xin@hengrui.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510120
      • Recruiting
      • Sun Yat-sen Memorial Hospital, Sun Yat-sen University
      • Contact: Erwei Song, Doctor; Email: songew@mail.sysu.edu.cn
      • Contact: Herui Yao, Doctor; Email: yaoherui@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part 1: Dose escalation	Drug: SHR-4602 for injection; be administered via intravenous (IV) infusion
Experimental: Part 2: PK expansion	Drug: SHR-4602 for injection; be administered via intravenous (IV) infusion
Experimental: Part 3: efficacy expansion	Drug: SHR-4602 for injection; be administered via intravenous (IV) infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence and severity of adverse events (AEs)	From Day 1 to 90 days after last dose
Maximum tolerated dose (MTD)	From Day 1 to 21 days after first dose
Dose Limiting Toxicities (DLT)	From Day 1 to 21 days after first dose
Recommended Phase 2 dose (RP2D)	From Day 1 to 90 days after last dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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: Tmax		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	Anti-drug antibody, Immunogenicity of SHR-4602 for Injection	the date of first dose up to 90 days after last dose
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
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
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
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

Collaborators and Investigators

• Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): April 18, 2023
• Primary Completion (Estimated): May 30, 2025
• Study Completion (Estimated): May 30, 2026

Study Registration Dates

• First Submitted: April 6, 2023
• First Submitted That Met QC Criteria: April 6, 2023
• First Posted (Actual): April 19, 2023

Study Record Updates

• Last Update Posted (Actual): June 21, 2024
• Last Update Submitted That Met QC Criteria: June 20, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: SHR-4602-I-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No