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NCT Number: NCT06754930

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

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 NSCLC.

Recruiting

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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

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, 200030, China

Location status: Recruiting

Location contact

Shun Lu

CONTACT

[email protected]

+86-13601813062

Shun Lu

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 NSCLC.
  • Be able to provide fresh or archived tumour tissue.
  • At least one measurable lesion according to RECIST v1.1.
  • Adequate 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.
  • Have undergone major surgery other than diagnosis or biopsy within 28 days prior to the initial dosing; Minor traumatic surgery within 7 days prior to the first dosing.
  • 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.
  • With poorly controlled or severe cardiovascular disease.
  • Active hepatitis B and 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 for injection.

SHR-1316

Drug

SHR-1316 for injection.

SHR-9839

Drug

SHR-9839 for injection.

SHR-8068

Drug

SHR-8068 for injection.

Ametinib mesylate

Drug

Ametinib mesylate.

BP-102

Drug

BP-102 for injection.

carboplatin

Drug

Carboplatin for injection.

Primary outcomes

  1. Recommended phase II dose (RP2D)

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

  2. Adverse events (AEs)

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

  3. Objective response rate (ORR)

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

Secondary outcomes

  1. Disease control rate (DCR)

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

  2. Duration of response (DoR)

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

  3. Progression-free survival (PFS)

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

  4. Overall survival (OS)

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

  5. Drug resistant antibody (ADA) to SHR-1826

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

  6. Blood concentration of SHR-1826

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

  7. Blood concentration of free toxin

    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.

Tingting Lei

CONTACT

[email protected]

+86-18610051325

Yijun Jia

CONTACT

[email protected]

+86-18801784695

Sponsors and collaborators

Lead sponsor

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Industry

Registry information

Official study title

A Multicenter, Open Phase IB/II Clinical Study of Safety, Tolerability, and Efficacy of SHR-1826 in Combination With Other Anti-cancer Treatment in Patients With Non-small Cell Lung Cancer

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jan 1, 2025
Registry last updated
Apr 17, 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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