RecruitingPhase 2NCT07241767

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

An Open Label, Multicenter Phase II Clinical Study on the Safety, Tolerability, and Efficacy of FH-006 Injection Combined With Other Anti-tumor Therapies in Lung Cancer Subjects

Sponsor

Jiangsu HengRui Medicine Co., Ltd.

Enrollment

200 participants

Start Date

Nov 12, 2025

Study Type

INTERVENTIONAL

Conditions

Lung Cancer

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.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria8

Age range: 18-75 years old (including both ends), gender is not limited.
Subjects with locally advanced or metastatic non-small cell lung cancer confirmed by histology or cytology as unsuitable for radical surgery or radiotherapy treatment
ECOG score is 0 or 1
Expected survival period ≥ 12 weeks
According to the RECIST v1.1 standard, there must be at least one measurable lesion.
Good level of organ function
The patient voluntarily joined this study and signed informed consent
Left ventricular ejection fraction (LVEF) ≥ 50%

Exclusion Criteria26

Suffering from other malignant tumors within the past 5 years
Subjects with active central nervous system (CNS) tumor metastasis, a history of meningeal metastasis, or current meningeal metastasis
Patients with uncontrollable tumor related pain
Has serious cardiovascular and cerebrovascular diseases
Significant clinically significant bleeding symptoms occurred within 3 months prior to the first study medication
Uncontrollable third interstitial fluid accumulation within 2 weeks of initial study medication
History of clinically significant pulmonary diseases
Receive other anti-tumor treatments within 4 weeks before the first medication
Severe infection within 4 weeks before the first medication
Active, known or suspected autoimmune diseases, and a history of autoimmune diseases.
History of immunodeficiency
Individuals with active pulmonary tuberculosis infection within the year prior to enrollment
Chest radiation therapy patients who received\>30 Gy within 24 weeks prior to the first use of the investigational drug
The adverse reactions of previous anti-tumor treatments have not yet recovered to ≤ Grade I
Surgical treatment of important organs within 4 weeks prior to the first use of medication
Use attenuated live vaccine within 28 days prior to the first use of the investigational drug
There are other serious physical or mental illnesses or laboratory abnormalities present
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
Having bleeding tendency, high risk of bleeding, coagulation dysfunction or thrombophilia tendency
Previously experienced hypertensive crisis or hypertensive encephalopathy
Suffering from significant vascular disease within 6 months prior to the first use of medication
Have undergone a biopsy or other minor surgery within 7 days prior to the first use of medication
Having severe, unhealed wounds, active ulcers, or untreated fractures
Gastrointestinal perforation occurred within 6 months prior to the first use of medication
hour proteinuria quantification ≥ 1g within 7 days before the first medication
CT/MRI indicates tumor surrounding or invading large blood vessels