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
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- RP2D (Recommended Phase II Dose)：This was determined through a comprehensive evaluation of safety data and pharmacokinetic characteristics.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 Criteria
- •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
- •24-hour proteinuria quantification ≥ 1g within 7 days before the first medication
- •CT/MRI indicates tumor surrounding or invading large blood vessels
Arms & Interventions
Part A
Intervention: FH-006 ; SHR-1316 ; BP102 ; Cisplatin ; Carboplatin (Drug)
Part B
Intervention: FH-006 ; SHR-1316 ; BP102 (Drug)
Part C
Intervention: FH-006; SHR-1316 ; SHR-8068 (Drug)
Outcomes
Primary Outcomes
RP2D (Recommended Phase II Dose)：This was determined through a comprehensive evaluation of safety data and pharmacokinetic characteristics.
Time Frame: 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.
Incidence of Treatment-Emergent Adverse Events
Time Frame: from first dose to disease progression or death, up to 3 years.
DLT (Dose-limiting toxicity)：Severe toxicity occurred 21 or 28 days after each subject received their first systemic anticancer treatment.
Time Frame: 21or28 days after the first administration of each subject
ORR (Objective Response Rate)
Time Frame: 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 Outcomes
- 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)
- Duration of response (DoR)(from first dose to disease progression or death, whichever comes first, up to 3 years)