Using SHR-1826 with other treatments for advanced solid tumors

Phase IB/II Study of Safety, Tolerability and Efficacy of SHR-1826 for Injection in Combination With Other Antitumor Therapies in Subjects With Solid Tumors

This study is testing if a new treatment called SHR-1826, used with other cancer therapies, can help people with advanced solid tumors feel better and manage their disease.

Quick facts

• Phase: PHASE1; PHASE2
• Study type: Interventional
• Enrollment: 876 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd. (industry)
• Drugs / interventions: radiation
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT06703177 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with a pathologically diagnosed advanced solid tumor and an ECOG score of 0-1.

Not a fit: Patients with a history of central nervous system metastasis or those with uncontrollable tumor-related pain 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 with similar combination therapies in treating advanced solid tumors, indicating potential for success.

Eligibility criteria

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 this trial is running

Guangzhou, Guangdong

• Sun Yat-Sen university cancer center — Guangzhou, Guangdong, China (RECRUITING)

Study contacts

• Study coordinator: Rongfu Mao, MD

Conditions: Advanced Solid Tumors