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

NCT ID: NCT06703177

Last Updated: 2025-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

876 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-18

Study Completion Date

2027-07-01

Brief Summary

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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

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Conditions

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Advanced Solid Tumors

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Single group

Group Type EXPERIMENTAL

SHR-1826

Intervention Type DRUG

SHR-1826

SHR-4642

Intervention Type DRUG

SHR-4642

SHR-9839

Intervention Type DRUG

SHR-9839

SHR-8068

Intervention Type DRUG

SHR-8068

Bevacizumab Injection

Intervention Type DRUG

Bevacizumab Injection

Fluorouracil Injection

Intervention Type DRUG

Fluorouracil Injection

Calcium Folinate Injection

Intervention Type DRUG

Calcium Folinate Injection

Adebrelimab Injection

Intervention Type DRUG

Adebrelimab Injection

Capecitabine tablets

Intervention Type DRUG

Capecitabine tablets, oral.

Interventions

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SHR-1826

SHR-1826

Intervention Type DRUG

SHR-4642

SHR-4642

Intervention Type DRUG

SHR-9839

SHR-9839

Intervention Type DRUG

SHR-8068

SHR-8068

Intervention Type DRUG

Bevacizumab Injection

Bevacizumab Injection

Intervention Type DRUG

Fluorouracil Injection

Fluorouracil Injection

Intervention Type DRUG

Calcium Folinate Injection

Calcium Folinate Injection

Intervention Type DRUG

Adebrelimab Injection

Adebrelimab Injection

Intervention Type DRUG

Capecitabine tablets

Capecitabine tablets, oral.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Suzhou Suncadia Biopharmaceuticals Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Sun Yat-Sen university cancer center

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Rongfu Mao, MD

Role: CONTACT

+86-021-61053363

Hao Shen, BS

Role: CONTACT

+86-021-61053363

Facility Contacts

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Ruihua Xu

Role: primary

+86-020-87343468

Other Identifiers

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SHR-1826-201

Identifier Type: -

Identifier Source: org_study_id

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