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Trial Title:
A Trial of Injectable SHR-A1811 in Combination With Pyrotinib or SHR-1316 in Subjects With Advanced Non-small Cell Lung Cancer
NCT ID:
NCT05482568
Condition:
Advanced Non-small Cell Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
An open, multicenter, dose-increasing/investigational Phase IB/II clinical trial
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
SHR-A1811 & Pyrotinib/SHR-A1811 & SHR-1316
Description:
Drug: SHR-A1811 & Pyrotinib
SHR-A1811： intravenous Pyrotinib：oral
Drug: SHR-A1811 & SHR-1316
SHR-A1811： intravenous SHR-1316： intravenous
Arm group label:
SHR-A1811 combined with Pyrotinib/SHR-A1811 combined with SHR-1316
Summary:
This study was an open, multicenter, dose-increasing/investigational Phase IB/II clinical
trial to evaluate the efficacy of SHR-A1811 in combination with other antitumor therapies
in subjects with advanced non-small cell lung cancer with HER2 . It can be divided into
two parts, Part A is the dose escalation and efficacy exploration study of SHR-A1811
combined with Pyrotinib, and Part B is the dose escalation and efficacy exploration study
of SHR-A1811 combined with SHR-1316.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Ability to give informed consent, signed and dated IRB/EC approved informed consent,
willing and able to comply with treatment planning visits, tests and other
procedural requirements
2. When signing the informed consent, the age is 18-75 years old (including both ends),
and there is no gender limitation
3. The ECOG score is 0 or 1
4. The expected survival is ≥12 weeks
5. Subjects with advanced or metastatic non-small cell lung cancer
6. Formalin fixed, paraffin-embedded tumor tissue blocks or sections of unstained tumor
specimens are provided
7. Subjects who have failed prior standard care or are intolerant to standard care
8. There is at least one measurable lesion
9. Vital organs are functioning well
10. Heart function is good
11. Agree to birth control
Exclusion Criteria:
1. There are untreated or active central nervous system (CNS) tumor metastases
2. Pleural, ascites, or pericardial effusion requiring intervention occurred within 7
days prior to initial administration
3. Systemic antitumor therapy was performed 4 weeks prior to study initiation
4. Prior treatment with antibody-conjugated drugs
5. Received >30 Gy chest radiation within 6 months prior to initial administration
6. Palliative radiotherapy was completed within 7 days prior to initial administration
7. Failure to recover from toxicity and/or complications of previous interventions to
nCI-CTCAE ≤1
8. The half-life of CYP3A4 suppressor, moderate inhibitor or strong inducer or moderate
inducer is less than 3 or less than 14 days from the date of first drug use, and the
shorter is selected
9. Received systemic immunosuppressant therapy within 14 days prior to the first study
10. Subjects with known or suspected interstitial pneumonia
11. In the first study, failure to swallow, chronic diarrhea, gastroenteritis,
intestinal obstruction, gastrointestinal perforation, postgastrectomy, or colitis,
or other medical conditions or special conditions affecting drug administration and
absorption occurred within 28 days prior to administration
12. Presence of any active, known or suspected autoimmune disease
13. Have poorly controlled or severe cardiovascular disease
14. Previous or concurrent malignancy
15. Subjects who developed a severe infection within 28 days prior to the first dose
16. Active hepatitis B
17. There were active tuberculosis patients within 1 year before enrollment
18. There is a history of immunodeficiency
19. Live attenuated vaccine was administered within 28 days prior to initial study
administration or is expected to be administered during study treatment
20. Subjects who are participating in another clinical study or who have had their first
dose less than 4 weeks since the end of the previous clinical study (last dose) or 5
half-lives of the study drug, whichever is shorter
21. Major surgery other than diagnosis or biopsy was performed within 28 days prior to
initial administration
22. People who are known to be allergic to sir-A1811, pyrrolitinib, or any of the
components of SIR-1316
23. History of severe allergic reactions to other monoclonal antibody/fusion protein
drugs
24. Female subjects who are pregnant, breast-feeding, or planning to become pregnant
during the study
25. Uncontrolled mental illness and other conditions known to affect the completion of
the study process, such as alcohol, drug or substance abuse and detention
26. Any other conditions that, in the investigator's judgment, may increase the risk of
study participation, interfere with study results, or make study participation
unsuitable
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Shanghai Chest hospital
Address:
City:
Shanghai
Zip:
200030
Country:
China
Status:
Recruiting
Investigator:
Last name:
Shun Lu
Email:
Principal Investigator
Facility:
Name:
Zhejiang Cancer Hospital
Address:
City:
Hangzhou
Zip:
310022
Country:
China
Status:
Recruiting
Investigator:
Last name:
Zhengbo Song
Email:
Principal Investigator
Start date:
September 15, 2022
Completion date:
December 30, 2024
Lead sponsor:
Agency:
Jiangsu HengRui Medicine Co., Ltd.
Agency class:
Industry
Source:
Jiangsu HengRui Medicine Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05482568
