Using SHR-1826 with other treatments for advanced solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This open-label, multi-center Phase IB/II study aims to evaluate the safety, tolerability, and efficacy of SHR-1826 in combination with other antitumor therapies for patients with advanced solid tumors. Participants will receive multiple doses of SHR-1826 along with other treatments such as Bevacizumab. The study will assess the response of the tumors to the treatment and monitor any side effects experienced by the patients. The research will include patients who can provide tumor tissue samples and have measurable lesions.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Voluntary participation and written informed consent;
2. 18-75 years older, no gender limitation;
3. Eastern Cooperative Oncology Group (ECOG) score: 0-1;
4. With a life expectancy ≥ 3 months;
5. Pathologically diagnosed advanced solid tumor;
6. Be able to provide fresh or archived tumour tissue;
7. At least one measurable lesion according to RECIST v1.1;
8. Adequate bone marrow reserve and organ function;
9. Contraception is required during clinical trials, and pregnancy tests must be negative for women of childbearing age within 7 days before the first dose.

Exclusion Criteria:

1. Meningeal metastasis history or clinical symptoms of central nervous system metastasis;
2. Previous or co-existing malignancies;
3. Spinal cord compression that was not treated radically by surgery and/or radiotherapy was excluded;
4. Uncontrollable tumor-related pain;
5. Previously received antiboy-coupled drug therapy with topoisomerase I inhibitor toxin; Previously received EGFR/c-Met double antibody;
6. Received systemic antitumor therapy before the first dose;
7. Have undergone major surgery other than diagnosis or biopsy within 28 days prior to initial dosing; Minor traumatic surgery within 7 days prior to first dosing;
8. For the first time, a study was conducted to treat patients with radiation therapy exceeding the prescribed dose before study treatment;
9. Received Other investigational drugs treatments 4 weeks prior to the initiation of the study treatment;
10. Unresolved CTCAE 5.0\>grade 2 toxicities from previous anticancer therapy;
11. A history of interstitial pneumonia/non-infectious pneumonia;
12. Accompanied by uncontrolled pleural effusion and pericardial effusion; Moderate or severe ascites with clinical symptoms;
13. Study the presence of intestinal obstruction or the presence of signs or symptoms of intestinal obstruction 6 months before first dosing;
14. With poorly controlled or severe cardiovascular disease;
15. Active hepatitis B, hepatitis C;
16. Patients with a history of immunodeficiency;
17. Severe infection 30 days before the first dose.

Where it's running

• Sun Yat-Sen university cancer center
  Guangzhou, Guangdong, China Recruiting

Study contacts

• Study coordinator: Rongfu Mao, MD
• Email: rongfu.mao@hengrui.com
• Phone: +86-021-61053363

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.