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

NCT06703177 | Recruiting Phase 1

• 1 other identifier: SHR-1826-201
• Study Type: interventional
• Target: 876
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced Solid Tumors

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (13)

• 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.

Study Arms (1)

Single group

EXPERIMENTAL

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; Drug: Capecitabine tablets

Interventions

SHR-1826 DRUG

SHR-1826

Single group

SHR-4642 DRUG

SHR-4642

Single group

SHR-9839 DRUG

SHR-9839

Single group

SHR-8068 DRUG

SHR-8068

Single group

Bevacizumab Injection DRUG

Bevacizumab Injection

Single group

Fluorouracil Injection DRUG

Fluorouracil Injection

Single group

Calcium Folinate Injection DRUG

Calcium Folinate Injection

Single group

Adebrelimab Injection DRUG

Adebrelimab Injection

Single group

Capecitabine tablets DRUG

Capecitabine tablets, oral.

Single group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntary participation and written informed consent;
• years older, no gender limitation;
• Eastern Cooperative Oncology Group (ECOG) score: 0-1;
• With a life expectancy ≥ 3 months;
• Pathologically diagnosed advanced solid tumor;
• Be able to provide fresh or archived tumour tissue;
• At least one measurable lesion according to RECIST v1.1;
• Adequate bone marrow reserve and organ function;
• Contraception is required during clinical trials, and pregnancy tests must be negative for women of childbearing age within 7 days before the first dose.

You may not qualify if:

• Meningeal metastasis history or clinical symptoms of central nervous system metastasis;
• Previous or co-existing malignancies;
• Spinal cord compression that was not treated radically by surgery and/or radiotherapy was excluded;
• Uncontrollable tumor-related pain;
• Previously received antiboy-coupled drug therapy with topoisomerase I inhibitor toxin; Previously received EGFR/c-Met double antibody;
• Received systemic antitumor therapy before the first dose;
• 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;
• For the first time, a study was conducted to treat patients with radiation therapy exceeding the prescribed dose before study treatment;
• Received Other investigational drugs treatments 4 weeks prior to the initiation of the study treatment;
• Unresolved CTCAE 5.0\>grade 2 toxicities from previous anticancer therapy;
• A history of interstitial pneumonia/non-infectious pneumonia;
• Accompanied by uncontrolled pleural effusion and pericardial effusion; Moderate or severe ascites with clinical symptoms;
• Study the presence of intestinal obstruction or the presence of signs or symptoms of intestinal obstruction 6 months before first dosing;
• With poorly controlled or severe cardiovascular disease;
• Active hepatitis B, hepatitis C;

Sponsors & Collaborators

• Suzhou Suncadia Biopharmaceuticals Co., Ltd.: lead

Study Sites (1)

Sun Yat-Sen university cancer center

Guangzhou, Guangdong, 510000, China

RECRUITING

MeSH Terms

Interventions

Bevacizumab; Fluorouracil; Leucovorin; Capecitabine

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Central Study Contacts

Rongfu Mao, MD

CONTACT

+86-021-61053363; rongfu.mao@hengrui.com

Hao Shen, BS

CONTACT

+86-021-61053363; hao.shen@hengrui.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2024
• First Posted: November 25, 2024
• Study Start: February 18, 2025
• Primary Completion: January 1, 2026
• Study Completion (Estimated): July 1, 2027
• Last Updated: December 3, 2025

Record last verified: 2025-11

Locations

CN (1)