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

Study Overview

• Status: Recruiting
• Conditions: Advanced Solid Tumors
• Intervention / Treatment: Drug: SHR-8068; Drug: SHR-1826; Drug: SHR-4642; Drug: SHR-9839; Drug: Bevacizumab Injection; Drug: Fluorouracil Injection; Drug: Calcium Folinate Injection; Drug: Adebrelimab Injection; Drug: Capecitabine tablets

• Study Type: Interventional
• Enrollment (Estimated): 876
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Rongfu Mao, MD; Phone Number: +86-021-61053363; Email: rongfu.mao@hengrui.com
• Study Contact Backup: Name: Hao Shen, BS; Phone Number: +86-021-61053363; Email: hao.shen@hengrui.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510000
      • Recruiting
      • Sun yat-sen University Cancer Center
      • Principal Investigator: Ruihua Xu
      • Contact: Ruihua Xu; Phone Number: +86-020-87343468; Email: xurh@sysucc.org.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single group	Drug: SHR-8068; SHR-8068; Drug: SHR-1826; SHR-1826; Drug: SHR-4642; SHR-4642; Drug: SHR-9839; SHR-9839; Drug: Bevacizumab Injection; Bevacizumab Injection; Drug: Fluorouracil Injection; Fluorouracil Injection; Drug: Calcium Folinate Injection; Calcium Folinate Injection; Drug: Adebrelimab Injection; Adebrelimab Injection; Drug: Capecitabine tablets; Capecitabine tablets, oral.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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.
Duration of response (DoR) (Phase 1)	Screening up to study completion, an average of 1 year.
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.

Collaborators and Investigators

• Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): February 18, 2025
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: November 19, 2024
• First Submitted That Met QC Criteria: November 22, 2024
• First Posted (Actual): November 25, 2024

Study Record Updates

• Last Update Posted (Estimated): December 3, 2025
• Last Update Submitted That Met QC Criteria: November 25, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Amino Acids, Peptides, and Proteins; Proteins; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Nucleic Acids, Nucleotides, and Nucleosides; Enzymes and Coenzymes; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Nucleosides; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Uracil; Pyrimidinones; Coenzymes; Deoxyribonucleosides; Capecitabine; Bevacizumab; Fluorouracil; Leucovorin
• Other Study ID Numbers: SHR-1826-201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No