Testing SHR-A2102 with other cancer treatments for advanced solid tumors
A Phase II, Multicenter, Open-Label Study of Safety, Tolerability and Efficacy of SHR-A2102 for Injection in Combination With Other Antitumor Therapies in Patients With Advanced Solid Tumors
This study is testing a new cancer treatment called SHR-A2102 combined with other therapies to see if it helps people with advanced solid tumors feel better and improve their outcomes.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 400 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Shanghai Hengrui Pharmaceutical Co., Ltd. Industry-sponsored |
| Locations | 1 site (Taiyuan, Shanxi) |
| Trial ID | NCT06895928 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety, tolerability, and efficacy of SHR-A2102 in combination with other antitumor therapies for patients with advanced solid tumors. The study aims to determine the appropriate dosage and assess the overall effectiveness of SHR-A2102 alongside treatments like Bevacizumab and Osimertinib. Participants will be monitored for their response to the treatment and any potential side effects. The trial is designed for patients who meet specific eligibility criteria, ensuring a focused approach to treatment.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 70 with measurable advanced solid tumors and good organ function.
Not a fit: Patients with uncontrolled central nervous system metastases or severe cardiovascular diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new effective treatment option for patients with advanced solid tumors.
How similar studies have performed: Other studies have shown promise in using combination therapies for advanced solid tumors, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. The age of signing the informed consent is 18 -70 years, regardless of gender. 2. At least one measurable lesion according to RECIST v1.1 criteria. 3. The ECOG score is 0 or 1. 4. Expected survival ≥12 weeks. 5. Good level of organ function. 6. Have the ability to give informed consent and to comply with the treatment plan. 7. Male subjects whose partners are women of childbearing age and female subjects who are fertile are required to use highly effective contraceptive methods. Exclusion Criteria: 1. Inadequately treated central nervous system metastases or the presence of uncontrolled or symptomatic active central nervous system metastases. 2. Spinal cord compression not cured by surgery and/or radiotherapy. 3. Subjects with uncontrolled tumor-related pain. 4. Received antitumor therapy within 4 weeks before the start of the study. 5. Subjects with severe cardiovascular and cerebrovascular disease. 6. History of immunodeficiency, including a positive HIV test.
Where this trial is running
Taiyuan, Shanxi
- Shanxi Cancer hospital — Taiyuan, Shanxi, China (Recruiting)
Study contacts
- Study coordinator: Yang Wu
- Email: yang.wu.yw96@hengrui.com
- Phone: +86-0518-82342973
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.