A Study of SHR-1826 for Injection in Combination With Other Antitumor Therapies in Subjects With Solid Tumors

Suzhou Suncadia Biopharmaceuticals

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Advanced Solid Tumors

Treatments: Drug: Capecitabine tablets; Drug: Bevacizumab Injection; Drug: Adebrelimab Injection; Drug: Calcium Folinate Injection; Drug: SHR-9839; Drug: SHR-1826; Drug: Fluorouracil Injection; Drug: SHR-4642; Drug: SHR-8068

Study type: Interventional

Funder types: Industry

Identifiers

NCT06703177

SHR-1826-201

Details and patient eligibility

About

This is an open label, multi-center, multiple dose Phase IB/II study to evaluate the safety, tolerability and efficacy of SHR-1826 for injection in subjects with advanced solid tumors.

Enrollment: 876 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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876 participants in 1 patient group

Single group

Experimental group

Treatment:

Drug: SHR-8068

Drug: SHR-4642

Drug: Fluorouracil Injection

Drug: SHR-1826

Drug: SHR-9839

Drug: Calcium Folinate Injection

Drug: Adebrelimab Injection

Drug: Bevacizumab Injection

Drug: Capecitabine tablets