Last updated: March 26, 2023
Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd.
Overall Status: Active - Recruiting
Phase
1
Condition
Neoplasms
Treatment
N/AClinical Study ID
NCT05735275
SHR-A2102-I-101
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Ability to understand and the willingness to sign a written informed consent document;
- Aged ≥18 years old;
- Histologically or cytologically confirmed advanced or metastatic malignant tumor;
- Presence of at least one measurable lesion in agreement to RECIST criteria;
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1;
- Life expectancy ≥3 months;
- Adequate organ performance based on laboratory blood tests;
- 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:
- Previous received anti-cancer systemic therapy including chemo-therapy, radiationtherapy, target therapy or immuno-therapy within 4 weeks before the first dose;
- Previous received experimental medication or therapy within 4 weeks before the firstdose;
- Previous therapeutic surgery within 4 weeks;
- Has unresolved toxicities from previous anticancer therapy, defined as toxicities notyet resolved to NCI-CTCAE version 5.0 grade ≤ 1.
- Known allergic to any compound of SHR-A2102;
- Patients with uncontrolled or active brain metastasis;
- Patients with clinical significant lung disease;
- Patients with history of autoimmune diseases;
- Known active hepatitis B or C infection;
- 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
ChinaActive - Recruiting
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