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

Launched by SHANGHAI HENGRUI PHARMACEUTICAL CO., LTD. · Feb 9, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment called SHR-A2102 for patients with advanced solid tumors, which are types of cancer that have spread beyond their original site. The main goals of this study are to see how safe the treatment is, how the body processes it, and whether it can help shrink tumors. This is the first time this treatment is being tested in humans, and the study is currently looking for participants.

To be eligible for the trial, you need to be at least 18 years old and have a confirmed diagnosis of an advanced or metastatic cancer, meaning it has spread to other parts of the body. You should also have at least one measurable tumor and be in relatively good health, with a life expectancy of at least three months. Participants will be monitored closely throughout the study and are required to use effective birth control if they are able to become pregnant. It’s important to note that if you have recently received other cancer treatments or have certain health conditions, you may not be able to join this trial. If you decide to participate, you will help researchers learn more about this potential new cancer treatment.

Gender

ALL

Eligibility 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.