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

NCT05819684 | Recruiting Phase 1

• 1 other identifier: SHR-4602-I-101
• Study Type: interventional
• Target: 133
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced Solid Tumor

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (9)

• 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

  the date of first dose up to 90 days after last dose

Study Arms (3)

Part 1: Dose escalation

EXPERIMENTAL

Drug: SHR-4602 for injection

Part 2: PK expansion

EXPERIMENTAL

Drug: SHR-4602 for injection

Part 3: efficacy expansion

EXPERIMENTAL

Drug: SHR-4602 for injection

Interventions

SHR-4602 for injection DRUG

be administered via intravenous (IV) infusion

Part 1: Dose escalation; Part 2: PK expansion; Part 3: efficacy expansion

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Suzhou Suncadia Biopharmaceuticals Co., Ltd.: lead

Study Sites (1)

Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University

Guangzhou, Guangdong, 510120, China

RECRUITING

MeSH Terms

Interventions

Injections

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Central Study Contacts

Xin Shi

CONTACT

0518-82342973; xin.shi.xs3@hengrui.com

Wenjie Xin

CONTACT

0518-82342973; wenjie.xin@hengrui.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 6, 2023
• First Posted: April 19, 2023
• Study Start: April 18, 2023
• Primary Completion: May 30, 2025
• Study Completion: May 30, 2026
• Last Updated: June 21, 2024

Record last verified: 2024-06

Locations

CN (1)