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

NCT06754930
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Phase
Phase 1/Phase 2
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Recruitment status
Recruiting
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Participants
400
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Lead sponsor
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
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Start date
2025-02-18
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Number of sites
1
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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 NSCLC.
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Short title
A Study of SHR-1826 for Injection in Combination With Other Antitumor Therapies in Subjects With NSCLC
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Official 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
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Control arm
Open label
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 1/Phase 2
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Study type
Interventional
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Completion date
2027-12-01
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First posted
2025-01-01
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Registry last updated
2025-04-17
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Primary completion date
2027-12-01
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Start date
2025-02-18
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Participants
400
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Participant count basis
Estimated
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Planned participants
400
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Protocol amendments
0
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Number of sites
1
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Registry sponsor category
Industry
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Lead sponsor
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
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Source registry
ClinicalTrials.gov
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Registry ID
NCT06754930
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ClinicalTrials.gov ID
NCT06754930
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Registry record
Open registry record
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Allocation
Not applicable
Model
Single group
Purpose
Treatment
Masking
No masking
Sources for study design
clinicaltrials.gov

  1. Recommended phase II dose (RP2D)

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

  2. Adverse events (AEs)

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

  3. Objective response rate (ORR)

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

  1. Disease control rate (DCR)

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

  2. Duration of response (DoR)

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

  3. Progression-free survival (PFS)

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

  4. Overall survival (OS)

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

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

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

  6. Blood concentration of SHR-1826

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

  7. Blood concentration of free toxin

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

Sources for outcomes
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Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Maximum age
75 Years
Healthy volunteers
No

  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 NSCLC.
  6. Be able to provide fresh or archived tumour tissue.
  7. At least one measurable lesion according to RECIST v1.1.
  8. Adequate 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.

  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. 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.
  6. Received other investigational drugs treatments 4 weeks prior to the initiation of the study treatment.
  7. Unresolved CTCAE 5.0>grade 2 toxicities from previous anticancer therapy.
  8. With poorly controlled or severe cardiovascular disease.
  9. Active hepatitis B and hepatitis C.
  10. Patients with a history of immunodeficiency.
  11. Severe infection 30 days before the first dose.
Sources for eligibility
clinicaltrials.gov

  • Shanghai Chest HospitalShanghai, ChinaRecruiting
Sources for sites
clinicaltrials.gov

Related records

Drugs (4)

Lead sponsors (1)

Conditions (1)

Targets (4)