Clinical trial NCT05214976: A Trial of Camrelizumab for Injection in Combination With Famitinib Malate Capsule and Paclitaxel For Injection(Albumin Bound) in Advanced Solid Tumors of Patients
Official title: A Phase Ⅰb/Ⅱ Clinical Study on the Open-label and Multiple Centers of Camrelizumab for Injection in Combination With Famitinib Malate Capsule and Paclitaxel For Injection(Albumin Bound) in Advanced Solid Tumors of Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Advanced Solid Tumors
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-01-31
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Camrelizumab for Injection in combination with Famitinib malate capsule and Paclitaxel
Primary purpose: TREATMENT

Brief summary: The study is being conducted to evaluate safety, tolerability and preliminary efficacy of Camrelizumab for Injection in combination with Famitinib malate capsule and Paclitaxel For Injection(Albumin Bound) for advanced solid tumors of patients. To explore the reasonable dosage of dosage regimen of combination therapy for advanced malignant tumors of patients.


Eligibility criteria: Inclusion Criteria:

1. Male or female aged ≥18 years and ≤75 years at the time of signing the ICF;
2. Dose Escalation Period: Histopathologically documented incurable advanced malignancies with standard treatment failure;
3. At least one measurable lesion that meets RECIST 1.1 criteria in case of solid tumors;
4. An Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1;
5. Life expectancy ≥3 months;
6. Adequate organ functions as defined;
7. Ability to understand and voluntarily agrees to participate by giving written informed consent for the study.

Exclusion Criteria:

1. The imaging examinations shows the tumor invades large blood vessels; Or as the assessment of the investigator, the tumor is highly likely to invade important blood vessels which would cause fatal bleeding during treatment;
2. The imaging examinations shows significant pulmonary cavitary tumors occurs with the bleeding risk as the investigator's assessment;
3. patients with active brain metastasis (without medical control or with clinical symptoms), cancerous meningitis, or spinal cord compression;
4. Uncontrollable pleural effusion, pericardial effusion or peritoneal effusion, with clinical symptoms;
5. Severe bong injury caused by metastatic tumor of bone;
6. Prior malignancy (other than current malignant tumor) within 3 years before the first dose of study treatment;
7. History of autoimmune diseases;
8. Evidence or history of arterial/venous thrombosis within 6 months before the first dose;
9. Patients with interstitial pneumonitis or interstitial lung disease; past history of interstitial pneumonitis or interstitial lung disease requiring hormone therapy;
10. When receiving immune checkpoint inhibitors previously, myocarditis related with immune, ≥ grade 2 of pneumonia related with immune or ≥ grade 3 of other adverse reactions related with immune occurred.

Primary outcomes:
measure: Dose Limited Toxicity
timeFrame: first dose of study medication up to 21 days]
measure: Recommended phase II dose
timeFrame: first dose of study medication up to 21 days
measure: ORR
timeFrame: from the date of the first dose to the date of disease progression evaluated based on RECIST v1.1 criteria, or initiation of other anti-tumor treatment, whichever occurs first, up to 6 months
Secondary outcomes:
measure: DoR
timeFrame: from the date of the firstly documented tumor response (evaluated based on RECIST v1.1 criteria) to the date of the firstly documented disease progression (evaluated based on RECIST v1.1 criteria) or the date of death for any reason, up to 6 months
measure: DCR
timeFrame: from the date of the first dose to the date of the firstly documented disease progression (evaluated based on RECIST v1.1 criteria) or the date of death for any reason, up to 6 months
measure: PFS
timeFrame: from the date of the first dose to the date of the firstly documented disease progression (evaluated based on RECIST v1.1 criteria) or the date of death for any reason, up to 6 months
measure: OS
timeFrame: from the date of the first dose to the date of death for any reason, up to 100 months
measure: 12 months' survival rate
timeFrame: from the date of the first dose up to 12 months
measure: TTF
timeFrame: from the date of the first dose to the date of treatment termination, up to 6 months
measure: Incidence and severity of adverse events (AEs)/serious adverse events (SAEs)
timeFrame: from signature completion of ICF to 90 days after the last dose or to the beginning of the new anti-cancer therapy, up to 6 months
measure: The occurrence rate of dose titration
timeFrame: from signature completion of ICF to 90 days after the last dose or to the beginning of the new anti-cancer therapy, up to 6 months
measure: concentration of drug in serum
timeFrame: 0.5 hour before first dose of Camrelizumab for Injection to 30 days after last dose
measure: concentration of drug in plasma
timeFrame: 2 days before first dose of Camrelizumab for Injection to 1 hour before the first dose of tenth cycle of Famitinib malate capsule
measure: Tmax
timeFrame: 2 days before first dose of Camrelizumab for Injection to 1 hour before the first dose of tenth cycle of Famitinib malate capsule
measure: Cmax
timeFrame: 2 days before first dose of Camrelizumab for Injection to 1 hour before the first dose of tenth cycle of Famitinib malate capsule
measure: AUC
timeFrame: 2 days before first dose of Camrelizumab for Injection to 1 hour before the first dose of tenth cycle of Famitinib malate capsule
measure: t1/2
timeFrame: 2 days before first dose of Camrelizumab for Injection to 1 hour before the first dose of tenth cycle of Famitinib malate capsule
measure: CL/F
timeFrame: 2 days before first dose of Camrelizumab for Injection to 1 hour before the first dose of tenth cycle of Famitinib malate capsule
measure: ADA
timeFrame: the date of first dose up to 30 days after last dose
measure: NAb
timeFrame: the date of first dose up to 30 days after last dose
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Chest Hospital
state: Shanghai
Study officials:
References: