A Phase 1 Study of SHR-A2102 in Subjects With Advanced Solid Tumors.

Last updated: March 26, 2023
Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd.
Overall Status: Active - Recruiting

Phase

1

Condition

Neoplasms

Treatment

N/A

Clinical Study ID

NCT05735275
SHR-A2102-I-101
  • Ages > 18
  • All Genders

Study Summary

This is a first in human, open-label, single-arm, multicenter dose escalation and expansion Phase 1 study of SHR-A2102 in patients with advanced or metastatic solid tumors. The purpose of this study is to assess the tolerability, safety, pharmacokinetics and immunogenicity of SHR-A2102 and preliminary anti-tumor efficacy

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Ability to understand and the willingness to sign a written informed consent document;
  2. Aged ≥18 years old;
  3. Histologically or cytologically confirmed advanced or metastatic malignant tumor;
  4. Presence of at least one measurable lesion in agreement to RECIST criteria;
  5. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1;
  6. Life expectancy ≥3 months;
  7. Adequate organ performance based on laboratory blood tests;
  8. Women of childbearing potential and men must agree to use adequate contraception priorto study entry and for the duration of study participation.

Exclusion

Exclusion Criteria:

  1. Previous received anti-cancer systemic therapy including chemo-therapy, radiationtherapy, target therapy or immuno-therapy within 4 weeks before the first dose;
  2. Previous received experimental medication or therapy within 4 weeks before the firstdose;
  3. Previous therapeutic surgery within 4 weeks;
  4. Has unresolved toxicities from previous anticancer therapy, defined as toxicities notyet resolved to NCI-CTCAE version 5.0 grade ≤ 1.
  5. Known allergic to any compound of SHR-A2102;
  6. Patients with uncontrolled or active brain metastasis;
  7. Patients with clinical significant lung disease;
  8. Patients with history of autoimmune diseases;
  9. Known active hepatitis B or C infection;
  10. Other serious accompanying illnesses, which, in the investigator's assessment, couldseriously adversely affect the safety of the treatment.

Study Design

Total Participants: 252
Study Start date:
March 03, 2023
Estimated Completion Date:
August 31, 2025

Connect with a study center

  • Beijing Cancer Hospital

    Beijing, Beijing 100142
    China

    Active - Recruiting

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