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

Phase 1

Recruiting

• Conditions: Advanced Solid Tumors
• Interventions: Drug: SHR-1826; Drug: SHR-4642; Drug: SHR-9839; Drug: SHR-8068; Drug: Bevacizumab Injection; Drug: Fluorouracil Injection; Drug: Calcium Folinate Injection; Drug: Adebrelimab Injection

• Registration Number: NCT06703177
• Lead Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-11-19
• Study First Submitted QC: 2024-11-22
• Study First Posted: 2024-11-25
• Status Verified: 2025-02
• Study Start: 2025-02-18
• Last Update Submitted: 2025-02-26
• Last Update Posted: 2025-02-27
• Primary Completion: 2026-01-01
• Study Completion: 2027-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 876

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single group	SHR-1826	-
Single group	SHR-4642	-
Single group	SHR-9839	-
Single group	SHR-8068	-
Single group	Bevacizumab Injection	-
Single group	Fluorouracil Injection	-
Single group	Calcium Folinate Injection	-
Single group	Adebrelimab Injection	-

Primary Outcome Measures

Name	Time	Method
RP2D (Phase 1)	Screening up to study completion, an average of 1 year.
AE (Phase 1)	Screening up to study completion, an average of 1 year.
Objective response rate (ORR) (Phase 2)	Screening up to study completion, an average of 1 year.

Secondary Outcome Measures

Name	Time	Method
Progression-free survival (PFS) (Phase 1)	Screening up to study completion, an average of 1 year.
Overall survival (OS) (Phase 1)	Screening up to study completion, an average of 1 year.
Drug Resistant Antibody (ADA) (Phase 1)	Screening up to study completion, an average of 1 year.
Blood concentration of SHR-1826 (Phase 1)	Screening up to study completion, an average of 1 year.
Blood concentration of free toxin SHR169265 (Phase 1)	Screening up to study completion, an average of 1 year.
Disease control rate (DCR) (Phase 2)	Screening up to study completion, an average of 1 year.
Duration of response (DoR) (Phase 2)	Screening up to study completion, an average of 1 year.
Progression-free survival (PFS) (Phase 2)	Screening up to study completion, an average of 1 year.
Overall survival (OS) (Phase 2)	Screening up to study completion, an average of 1 year.
AE (Phase 2)	Screening up to study completion, an average of 1 year.
Duration of response (DoR) (Phase 1)	Screening up to study completion, an average of 1 year.
Objective response rate (ORR) (Phase 1)	Screening up to study completion, an average of 1 year.
Disease control rate (DCR) (Phase 1)	Screening up to study completion, an average of 1 year.

Trial Locations

Locations (1)

Sun Yat-Sen university cancer center; 🇨🇳 Guangzhou, Guangdong, China