A Study of SHR-1826 for Injection in Combination With Other Antitumor Therapies in Subjects With NSCLC
Recruiting · NCT06754930 · Interventional (participants receive a specific treatment) · Lead sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Age range
18 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1, Phase 2
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
1 location listed.
- Shanghai Chest Hospital - Shanghai, Shanghai Municipality, China