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

Sponsor
Suzhou Suncadia Biopharmaceuticals Co., Ltd. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05819684
Collaborator
(none)
133
Enrollment
3
Arms
36
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: SHR-4602 for injection
 Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
133 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Intervention Model Description:
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.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.
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
May 30, 2023
Anticipated Primary Completion Date :
May 30, 2025
Anticipated Study Completion Date :
May 30, 2026

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Incidence and severity of adverse events (AEs) [From Day 1 to 90 days after last dose]

  2. Maximum tolerated dose (MTD) [From Day 1 to 21 days after first dose]

  3. Dose Limiting Toxicities (DLT) [From Day 1 to 21 days after first dose]

  4. Recommended Phase 2 dose (RP2D) [From Day 1 to 90 days after last dose]

Secondary Outcome Measures

  1. PK parameters of SHR-4602 for Injection: Cmax [the date of first dose to 30 days after last dose]

  2. PK parameters of SHR-4602 for Injection: AUC0-t [the date of first dose to 30 days after last dose]

  3. PK parameters of SHR-4602 for Injection: Tmax [the date of first dose to 30 days after last dose]

  4. PK parameters of SHR-4602 for Injection: T1/2 [the date of first dose to 30 days after last dose]

  5. ADA [the date of first dose up to 90 days after last dose]

    Anti-drug antibody, Immunogenicity of SHR-4602 for Injection

  6. ORR [the date of first dose up to 90 days after last dose]

    Objective Response Rate, Efficacy endpoints of SHR-4602 for Injection，As assessed by RECIST v1.1

  7. DCR [the date of first dose up to 90 days after last dose]

    Disease control rate, Efficacy endpoints of SHR-4602 for Injection，As assessed by RECIST v1.1

  8. DOR [the date of first dose up to 90 days after last dose]

    Duration of response, Efficacy endpoints of SHR-4602 for Injection，As assessed by RECIST v1.1

  9. PFS [the date of first dose up to 90 days after last dose]

    Progression Free Survival, Efficacy endpoints of SHR-4602 for Injection，As assessed by RECIST v1.1

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
ClinicalTrials.gov Identifier:
NCT05819684
Other Study ID Numbers:
  • SHR-4602-I-101
First Posted:
Apr 19, 2023
Last Update Posted:
Apr 19, 2023
Last Verified:
Apr 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Neoplasms

Study Results

No Results Posted as of Apr 19, 2023