A Trial of SHR-4602 Infusion in Patients With SHR-4602 in Subjects With HER2-expressing or HER2-mutated Locally Advanced or Metastatic Solid Tumors

NCT06560138 | Withdrawn Phase 1

• 1 other identifier: SHR-4602-102
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 5

Brief Summary

To evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of SHR-4602 in subjects with HER2-expressing or HER2-mutated locally advanced or metastatic solid tumors.

Conditions

HER2-expressing or HER2-mutated Locally or Metastatic Solid Tumors

Outcome Measures

Primary Outcomes (1)

• the phase II dose (RP2D) of SHR-4602

  RP2D is defined as the dose of SHR-4602 recommended for efficacy study in Phase II. It will be the dose with promising clinical responses observed in the subjects, well tolerated by subjects without exceeding a pre-set number of adverse events.

  From the time when the subjects sign the informed consent form to 45(±3) days after the last dose of SHR-4602, or the start of new anti-tumor treatment (whichever comes first).assessed for a maximum duration of up to 1 year

Secondary Outcomes (17)

• Cmax

  Pre-set time points: from C1D1 within 1 hour pre-dose to 30 ± 7 days, after EOT up to 1 year

• Tmax

  Pre-set time points: from C1D1 within 1 hour pre-dose to 30 ± 7 days, after EOT up to 1 year

• Css, max,

  Pre-set time points: from C1D1 within 1 hour pre-dose to 30 ± 7 days, after EOT up to 1 year

• Css, min

  Pre-set time points: from C1D1 within 1 hour pre-dose to 30 ± 7 days, after EOT up to 1 year

• AUC0-t

  Pre-set time points: from C1D1 within 1 hour pre-dose to 30 ± 7 days, after EOT up to 1 year

Study Arms (1)

SHR-4602 Dose level 1 : 2.0 mg/kg, Dose level 2 : 2.5mg/kg

EXPERIMENTAL

Drug: SHR-4602

Interventions

SHR-4602 DRUG

SHR-4602 will be administered through IV infusion.

SHR-4602 Dose level 1 : 2.0 mg/kg, Dose level 2 : 2.5mg/kg

Eligibility Criteria

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

You may qualify if:

• Ability to understand the trial procedures and possible adverse events, voluntarily participate in the trial.
• ECOG PS score 0 or 1
• Life expectancy ≥ 12 weeks
• Adequate bone marrow and other vital organ functions
• Adequate liver function tests
• HER 2 exprission advanced solid tumor

You may not qualify if:

• Ability to understand the trial procedures and possible adverse events, voluntarily participate in the trial.
• ECOG PS score 0 or 1
• Life expectancy ≥ 12 weeks
• Adequate bone marrow and other vital organ functions
• Adequate liver function tests
• HER 2 exprission advanced solid tumor
• Active brain metastases, carcinomatous meningitis/leptomeningeal metastases.
• Have received surgery (eg. major surgerical treatment for cancer), chemotherapy, molecular targeted therapy, immunotherapy, cell therapy, or radiotherapy within 4 weeks prior to the first dose of investigational drug (palliative radiotherapy within 2 weeks prior to the first dose).
• Participated in another clinical study with the last dose of study drug received in less than 4 weeks prior to the first dose.
• Subjects with toxicities and/or complications from prior treatment not recovered to NCI-CTCAE Grade ≤ 1.
• History of pleural fluid, ascites, or pericardial effusion requiring intervention within 2 weeks prior to the first dose.
• History of active autoimmune diseases.
• History of hereditary or acquired bleeding disorders or thrombotic tendency
• Active hepatitis B (defined as hepatitis B virus surface antigen \[HBsAg\] positive and serum HBV-DNA copy ≥ 500 IU/mL), hepatitis C
• History of severe infection within the past 30 days, including but not limited to bacteremia, severe sepsis, pneumonia requiring hospitalization

Sponsors & Collaborators

• Atridia Pty Ltd.: lead

Study Sites (5)

Scientia Clinical Research Limited

Randwick, New South Wales, 2031, Australia

Location

Macquarie University

Sydney, New South Wales, 2109, Australia

Location

Icon Cancer Centre South Brisbane

Brisbane, Queensland, 4101, Australia

Location

Cancer Research SA

Adelaide, South Australia, 500, Australia

Location

Peninsula & South Eastern Haematology and Oncology Group

Frankston, Victoria, 3199, Australia

Location

Study Design

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

Model Details: SHR-4602 injection only

Study Record Dates

• First Submitted: August 15, 2024
• First Posted: August 19, 2024
• Study Start: March 1, 2025
• Primary Completion: December 14, 2025
• Study Completion (Estimated): September 12, 2026
• Last Updated: January 7, 2025

Record last verified: 2024-09

Locations

AU (5)