Advanced Solid Tumors
Conditions
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.
Interventions
DRUGCamrelizumab for Injection, Famitinib malate capsule, Paclitaxel For Injection(Albumin Bound)
Firstly Dose Escalation of Camrelizumab for Injection in combination with Famitinib malate capsule and Paclitaxel For Injection(Albumin Bound) should be conducted. According to the DLT data in the dose escalation period, dosage of Famitinib malate capsule or Paclitaxel For Injection(Albumin Bound) would be adjusted. After dose escalation period, in order to evaluate the tolerance, study would choose the dosage regimen to complete the Dose Expansion period. The indication expansion would be conducted after that. The study would select specific indications based on the previous efficacy data with the RP2D of the combination therapy.
Sponsors
Jiangsu HengRui Medicine Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Camrelizumab for Injection in combination with Famitinib malate capsule and Paclitaxel
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dose Limited Toxicity | first dose of study medication up to 21 days] | Dose Limited Toxicity of Camrelizumab for Injection in combination with Famitinib malate capsule and Paclitaxel For Injection(Albumin Bound) |
| Recommended phase II dose | first dose of study medication up to 21 days | The Recommended phase II dose of Camrelizumab for Injection in combination with Famitinib malate capsule and Paclitaxel For Injection(Albumin Bound) |
| ORR | 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 | Objective Response Rate, Efficacy endpoints of Camrelizumab for Injection in combination with Famitinib malate capsule and Paclitaxel For Injection(Albumin Bound) in Advanced Solid Tumors of Patients |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| OS | from the date of the first dose to the date of death for any reason, up to 100 months | Overall survival, Efficacy endpoints of Camrelizumab for Injection in combination with Famitinib malate capsule and Paclitaxel For Injection(Albumin Bound) in Advanced Solid Tumors of Patients |
| 12 months' survival rate | from the date of the first dose up to 12 months | Efficacy endpoints of Camrelizumab for Injection in combination with Famitinib malate capsule and Paclitaxel For Injection(Albumin Bound) in Advanced Solid Tumors of Patients |
| TTF | from the date of the first dose to the date of treatment termination, up to 6 months | Time to Failure, Efficacy endpoints of Camrelizumab for Injection in combination with Famitinib malate capsule and Paclitaxel For Injection(Albumin Bound) in Advanced Solid Tumors of Patients |
| Incidence and severity of adverse events (AEs)/serious adverse events (SAEs) | 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 | Incidence and severity of adverse events (AEs)/serious adverse events (SAEs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0 |
| The occurrence rate of dose titration | 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 | The occurrence rate of dose interruption, dose decrease and dose termination because of study drug related toxicity during the study |
| concentration of drug in serum | 0.5 hour before first dose of Camrelizumab for Injection to 30 days after last dose | PK concentration of Camrelizumab for Injection |
| concentration of drug in plasma | 2 days before first dose of Camrelizumab for Injection to 1 hour before the first dose of tenth cycle of Famitinib malate capsule | PK concentration of Famitinib malate capsule and its intermediate metabolite, and Paclitaxel For Injection(Albumin Bound) |
| DoR | 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 | Duration of response, Efficacy endpoints of Camrelizumab for Injection in combination with Famitinib malate capsule and Paclitaxel For Injection(Albumin Bound) in Advanced Solid Tumors of Patients |
| Cmax | 2 days before first dose of Camrelizumab for Injection to 1 hour before the first dose of tenth cycle of Famitinib malate capsule | PK parameters of Famitinib malate capsule and its intermediate metabolite, and Paclitaxel For Injection(Albumin Bound) |
| AUC | 2 days before first dose of Camrelizumab for Injection to 1 hour before the first dose of tenth cycle of Famitinib malate capsule | PK parameters of Famitinib malate capsule and its intermediate metabolite, and Paclitaxel For Injection(Albumin Bound) |
| t1/2 | 2 days before first dose of Camrelizumab for Injection to 1 hour before the first dose of tenth cycle of Famitinib malate capsule | PK parameters of Famitinib malate capsule and its intermediate metabolite, and Paclitaxel For Injection(Albumin Bound) |
| CL/F | 2 days before first dose of Camrelizumab for Injection to 1 hour before the first dose of tenth cycle of Famitinib malate capsule | PK parameters of Famitinib malate capsule and its intermediate metabolite, and Paclitaxel For Injection(Albumin Bound) |
| ADA | the date of first dose up to 30 days after last dose | Anti-drug antibody, Immunogenicity of Camrelizumab for Injection |
| NAb | the date of first dose up to 30 days after last dose | Neutralizing Antibody, Immunogenicity of Camrelizumab for Injection |
| Tmax | 2 days before first dose of Camrelizumab for Injection to 1 hour before the first dose of tenth cycle of Famitinib malate capsule | PK parameters of Famitinib malate capsule and its intermediate metabolite, and Paclitaxel For Injection(Albumin Bound) |
| DCR | 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 | Disease control rate, Efficacy endpoints of Camrelizumab for Injection in combination with Famitinib malate capsule and Paclitaxel For Injection(Albumin Bound) in Advanced Solid Tumors of Patients |
| PFS | 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 | Progression-free survival, Efficacy endpoints of Camrelizumab for Injection in combination with Famitinib malate capsule and Paclitaxel For Injection(Albumin Bound) in Advanced Solid Tumors of Patients |
Countries
China
Outcome results
None listed