Testing SHR-A2102 in patients with advanced solid tumors
Safety, Tolerability, Pharmacokinetics, and Efficacy of SHR-A2102, In Subjects With Locally Advanced Or Metastatic Solid Tumor Malignancies: A Phase I Open-Label, One-Arm, Multicenter Study.
This study is testing a new treatment called SHR-A2102 to see if it is safe and effective for people with advanced solid tumors.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 252 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Shanghai Hengrui Pharmaceutical Co., Ltd. Industry-sponsored |
| Drugs / interventions | radiation |
| Locations | 1 site (Beijing, Beijing) |
| Trial ID | NCT05735275 on ClinicalTrials.gov |
What this trial studies
This is a first-in-human, open-label, single-arm Phase 1 study evaluating SHR-A2102 in patients with advanced or metastatic solid tumors. The study aims to assess the tolerability, safety, pharmacokinetics, immunogenicity, and preliminary anti-tumor efficacy of SHR-A2102. Participants will receive the treatment in a dose escalation and expansion format across multiple centers. The study will include patients who meet specific eligibility criteria related to their cancer diagnosis and overall health.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with histologically or cytologically confirmed advanced or metastatic solid tumors and at least one measurable lesion.
Not a fit: Patients who have received anti-cancer systemic therapy or experimental medications within the last four weeks may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors.
How similar studies have performed: While this is a first-in-human study, similar approaches in early-phase trials have shown promise in treating advanced solid tumors.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Beijing, Beijing
- Beijing Cancer Hospital — Beijing, Beijing, China (Recruiting)
Study contacts
- Study coordinator: Qi Zhang
- Email: qi.zhang@hengrui.com
- Phone: +0518-81220121
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.