A Phase II Clinical Study of FH-006 for Injection Combined With Other Anticancer Therapies in Subjects With Lung Cancer

Hengrui Medicine

Status and phase: Enrolling; Phase 2

Conditions: Lung Cancer

Treatments: Drug: FH-006 ; SHR-1316 ; BP102; Drug: FH-006 ; SHR-1316 ; BP102 ; Cisplatin ; Carboplatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT07241767

FH-006-201-LC

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Part A

Experimental group

Treatment:

Drug: FH-006 ; SHR-1316 ; BP102 ; Cisplatin ; Carboplatin

Part B

Experimental group

Treatment:

Drug: FH-006 ; SHR-1316 ; BP102