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NCT Number: NCT06703177

A Study 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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Sun Yat-Sen university cancer center

Guangzhou, Guangdong, 510000, China

Location status: Recruiting

Location contact

Ruihua Xu

CONTACT

[email protected]

+86-020-87343468

Ruihua Xu

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Voluntary participation and written informed consent;
  • 18-75 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.

Exclusion criteria

  • 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;
  • Patients with a history of immunodeficiency;
  • Severe infection 30 days before the first dose.

Treatment and study plan

SHR-1826

Drug

SHR-1826

SHR-4642

Drug

SHR-4642

SHR-9839

Drug

SHR-9839

SHR-8068

Drug

SHR-8068

Bevacizumab Injection

Drug

Bevacizumab Injection

Fluorouracil Injection

Drug

Fluorouracil Injection

Calcium Folinate Injection

Drug

Calcium Folinate Injection

Adebrelimab Injection

Drug

Adebrelimab Injection

Capecitabine tablets

Drug

Capecitabine tablets, oral.

Primary outcomes

  1. RP2D (Phase 1)

    Time frame: Screening up to study completion, an average of 1 year.

  2. AE (Phase 1)

    Time frame: Screening up to study completion, an average of 1 year.

  3. Objective response rate (ORR) (Phase 2)

    Time frame: Screening up to study completion, an average of 1 year.

Secondary outcomes

  1. Objective response rate (ORR) (Phase 1)

    Time frame: Screening up to study completion, an average of 1 year.

  2. Disease control rate (DCR) (Phase 1)

    Time frame: Screening up to study completion, an average of 1 year.

  3. Duration of response (DoR) (Phase 1)

    Time frame: Screening up to study completion, an average of 1 year.

  4. Progression-free survival (PFS) (Phase 1)

    Time frame: Screening up to study completion, an average of 1 year.

  5. Overall survival (OS) (Phase 1)

    Time frame: Screening up to study completion, an average of 1 year.

  6. Drug Resistant Antibody (ADA) (Phase 1)

    Time frame: Screening up to study completion, an average of 1 year.

  7. Blood concentration of SHR-1826 (Phase 1)

    Time frame: Screening up to study completion, an average of 1 year.

  8. Blood concentration of free toxin SHR169265 (Phase 1)

    Time frame: Screening up to study completion, an average of 1 year.

  9. Disease control rate (DCR) (Phase 2)

    Time frame: Screening up to study completion, an average of 1 year.

  10. Duration of response (DoR) (Phase 2)

    Time frame: Screening up to study completion, an average of 1 year.

  11. Progression-free survival (PFS) (Phase 2)

    Time frame: Screening up to study completion, an average of 1 year.

  12. Overall survival (OS) (Phase 2)

    Time frame: Screening up to study completion, an average of 1 year.

  13. AE (Phase 2)

    Time frame: Screening up to study completion, an average of 1 year.

Study contacts

Contact information is provided by the study sponsor or research team.

Hao Shen, BS

CONTACT

[email protected]

+86-021-61053363

Rongfu Mao, MD

CONTACT

[email protected]

+86-021-61053363

Sponsors and collaborators

Lead sponsor

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Nov 25, 2024
Registry last updated
Dec 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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