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

• Status: Not yet recruiting
• Trial end date: 2025-08-31
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd.

Criteria

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 prior to study entry and for the duration of study participation.

Exclusion Criteria:

1. Previous received anti-cancer systemic therapy including chemo-therapy, radiation therapy, target therapy or immuno-therapy within 4 weeks before the first dose;

2. Previous received experimental medication or therapy within 4 weeks before the first dose;

3. Previous therapeutic surgery within 4 weeks;

4. Has unresolved toxicities from previous anticancer therapy, defined as toxicities not yet 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, could seriously adversely affect the safety of the treatment.