Clinical trial NCT06754930: A Study of SHR-1826 for Injection in Combination With Other Antitumor Therapies in Subjects With NSCLC
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Non-small Cell Lung Cancer (NSCLC)
Lead sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2025-01-01
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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 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.

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. 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.

Primary outcomes:
measure: Recommended phase II dose (RP2D)
timeFrame: Screening up to study completion, an average of 1 year.
measure: Adverse events (AEs)
timeFrame: Screening up to study completion, an average of 1 year.
measure: Objective response rate (ORR)
timeFrame: Screening up to study completion, an average of 1 year.
Secondary outcomes:
measure: Disease control rate (DCR)
timeFrame: Screening up to study completion, an average of 1 year.
measure: Duration of response (DoR)
timeFrame: Screening up to study completion, an average of 1 year.
measure: Progression-free survival (PFS)
timeFrame: Screening up to study completion, an average of 1 year.
measure: Overall survival (OS)
timeFrame: Screening up to study completion, an average of 1 year.
measure: Drug resistant antibody (ADA) to SHR-1826
timeFrame: Screening up to study completion, an average of 1 year.
measure: Blood concentration of SHR-1826
timeFrame: Screening up to study completion, an average of 1 year.
measure: Blood concentration of free toxin
timeFrame: Screening up to study completion, an average of 1 year.
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Chest Hospital
state: Shanghai
Study officials:
References: