Lung Cancer
Conditions
Brief summary
Evaluate the safety, tolerability, pharmacokinetics, and immunogenicity of FH-006 in combination with other anti-tumor treatments in lung cancer subjects, and determine the recommended dose (RP2D) and initial efficacy for phase II clinical trials.
Interventions
DRUGFH-006 ; SHR-1316 ; BP102 ; Cisplatin ; Carboplatin
FH-006 ; SHR-1316 ; BP102 ; Cisplatin ; Carboplatin
DRUGFH-006 ; SHR-1316 ; BP102
FH-006 ; SHR-1316 ; BP102
DRUGFH-006; SHR-1316 ; SHR-8068
FH-006; SHR-1316 ; SHR-8068
Sponsors
Jiangsu HengRui Medicine Co., Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Age range: 18-75 years old (including both ends), gender is not limited. 2. Subjects with locally advanced or metastatic non-small cell lung cancer confirmed by histology or cytology as unsuitable for radical surgery or radiotherapy treatment 3. ECOG score is 0 or 1 4. Expected survival period ≥ 12 weeks 5. According to the RECIST v1.1 standard, there must be at least one measurable lesion. 6. Good level of organ function 7. The patient voluntarily joined this study and signed informed consent 8. Left ventricular ejection fraction (LVEF) ≥ 50%
Exclusion criteria
1. Suffering from other malignant tumors within the past 5 years 2. Subjects with active central nervous system (CNS) tumor metastasis, a history of meningeal metastasis, or current meningeal metastasis 3. Patients with uncontrollable tumor related pain 4. Has serious cardiovascular and cerebrovascular diseases 5. Significant clinically significant bleeding symptoms occurred within 3 months prior to the first study medication 6. Uncontrollable third interstitial fluid accumulation within 2 weeks of initial study medication 7. History of clinically significant pulmonary diseases 8. Receive other anti-tumor treatments within 4 weeks before the first medication 9. Severe infection within 4 weeks before the first medication 10. Active, known or suspected autoimmune diseases, and a history of autoimmune diseases. 11. History of immunodeficiency 12. Individuals with active pulmonary tuberculosis infection within the year prior to enrollment 13. Chest radiation therapy patients who received\>30 Gy within 24 weeks prior to the first use of the investigational drug 14. The adverse reactions of previous anti-tumor treatments have not yet recovered to ≤ Grade I 15. Surgical treatment of important organs within 4 weeks prior to the first use of medication 16. Use attenuated live vaccine within 28 days prior to the first use of the investigational drug 17. There are other serious physical or mental illnesses or laboratory abnormalities present 18. Pregnant, lactating women, or female participants who plan to become pregnant within 14 months after the last use of the investigational drug during the study period 19. Having bleeding tendency, high risk of bleeding, coagulation dysfunction or thrombophilia tendency 20. Previously experienced hypertensive crisis or hypertensive encephalopathy 21. Suffering from significant vascular disease within 6 months prior to the first use of medication 22. Have undergone a biopsy or other minor surgery within 7 days prior to the first use of medication 23. Having severe, unhealed wounds, active ulcers, or untreated fractures 24. Gastrointestinal perforation occurred within 6 months prior to the first use of medication 25. 24-hour proteinuria quantification ≥ 1g within 7 days before the first medication 26. CT/MRI indicates tumor surrounding or invading large blood vessels
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| DLT (Dose-limiting toxicity)：Severe toxicity occurred 21 or 28 days after each subject received their first systemic anticancer treatment. | 21or28 days after the first administration of each subject | — |
| Incidence of Treatment-Emergent Adverse Events | from first dose to disease progression or death, up to 3 years. | — |
| RP2D (Recommended Phase II Dose)：This was determined through a comprehensive evaluation of safety data and pharmacokinetic characteristics. | from first dose to disease progression or death, up to 3 years | This was determined through a comprehensive evaluation of safety data and pharmacokinetic characteristics. |
| ORR (Objective Response Rate) | from first dose to disease progression or death, whichever comes first, up to 3 years | The proportion of patients whose tumor volume shrank to the pre-defined standard (complete or partial response) after treatment. |
Secondary
| Measure | Time frame |
|---|---|
| Duration of response (DoR) | from first dose to disease progression or death, whichever comes first, up to 3 years |
| disease control rate (DCR) | from first dose to disease progression or death, whichever comes first, up to 3 years |
| progression free survival (PFS) | from first dose to disease progression or death, whichever comes first, up to 3 years |
| overall survival (OS) | from first dose to disease progression or death, whichever comes first, up to 3 years |
Countries
China
Contacts
CONTACTXiaouxe Pi
Outcome results
None listed