Testing SHR-1826 in patients with advanced solid tumors

A Multicenter, Open Phase I Clinical Study of Safety, Tolerability, Pharmacokinetics, and Efficacy of SHR-1826 for Injection in Patients With Advanced Solid Tumors

This study is testing a new drug called SHR-1826 to see if it is safe and effective for people with advanced solid tumors.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 240 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd. (Industry-sponsored)
• Drugs / interventions: radiation
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT06094556 on ClinicalTrials.gov

What this trial studies

This open, multi-center Phase I clinical trial evaluates the safety, tolerability, pharmacokinetics, and immunogenicity of SHR-1826 in patients with advanced malignant solid tumors. The study is structured in three stages: dose increment, dose extension, and therapeutic effect extension, allowing for a comprehensive assessment of the drug's efficacy. Participants will be closely monitored for any adverse effects and the overall response to treatment.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with advanced or metastatic solid tumors that are not responding to standard treatments.

Not a fit: Patients with untreated or active central nervous system tumor metastasis or those with uncontrolled tumor-related pain 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 who have limited or no effective standard treatment options.

How similar studies have performed: While this approach is part of ongoing research in the field, the specific drug SHR-1826 is being evaluated for the first time in this context.

Eligibility criteria

Inclusion Criteria:

1. Able and willing to provide a written informed consent.
2. 18-75 years old ，Male or female.
3. ECOG score is 0 or 1.
4. Subjects with advanced or metastatic solid tumors that have been documented by histopathology and are not responding to or tolerated by standard treatment, or have no effective standard treatment options.
5. Have at least one measurable lesion according to RECIST v1.1 criteria.
6. Expected survival ≥3 months .
7. With good vital organ function.
8. Contraception.

Exclusion Criteria:

1. With untreated or active Central nervous system (CNS) tumor metastasis. Subjects with a history or current history of meningeal metastasis.
2. Previous or co-existing malignant tumors.
3. Spinal cord compression that was not treated radically by surgery and/or radiotherapy was excluded.
4. Patients with uncontrolled tumor-related pain.
5. Received systemic antitumor therapy 4 weeks before starting study treatment; Previously receiving small molecule targeted therapy, the interval of not less than 5 half-lives of the drug can be enrolled.
6. Previously received antibody-coupled drug therapy.
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. First study subjects receiving \>30Gy non-radical chest radiation within 28 days prior to administration, \>30Gy chest radiation within 24 weeks prior to first administration, and ≤30Gy palliative radiation within 14 days prior to first administration;If previously received radioisotope therapy, the interval of not less than 5 half-lives of the isotope drug can be included.
9. Is participating in another clinical study or the time of first administration is less than 4 weeks from the end of the previous clinical study (last administration), or the 5 half-life of the investigational drug, whichever is the older.
10. The AE caused by previous anti-tumor therapy did not recover to CTCAE v5.0 grade evaluation ≤1.
11. Other severe lung diseases that may interfere with the detection or management of drug-related pulmonary toxicity within the first three months of administration that significantly affect respiratory function; Any autoimmune, connective tissue, or inflammatory disease with lung involvement; Prior left or right total lung resection.
12. Pleural effusion, ascites, or pericardial effusion requiring intervention occurred within 2 weeks prior to the first dose.
13. Have an active autoimmune disease, or other acquired (HIV infection), congenital immunodeficiency disease, or a history of organ transplantation.
14. Have poorly controlled or severe cardiovascular disease.
15. Known hereditary or acquired bleeding and thrombotic tendencies, and clinically significant bleeding symptoms and arterial/venous thrombosis events in the 3 months prior to the first dose.
16. Untreated active hepatitis.
17. Subjects who had a severe infection within 30 days prior to the first dose; Patients with active pulmonary tuberculosis infection within 1 year prior to enrollment were found by medical history or CT examination, or had a history of active pulmonary tuberculosis infection more than 1 year ago but had not received regular treatment.
18. Live attenuated vaccine should be administered within 30 days prior to the first dose.
19. Female subjects who are pregnant, breastfeeding, or planning to become pregnant during the study period.
20. Known allergy to any component or excipient of the SHR-1826 product.
21. The presence of other serious physical or mental illnesses or abnormalities in laboratory tests that may increase the risk of participation in the study, or interfere with the study results, as well as conditions that the investigator deems inappropriate to participate in the study.

Where this trial is running

Guangzhou, Guangdong

• Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (Recruiting)

Study contacts

• Study coordinator: Yijun Jia

Conditions Advanced Solid Tumors