A Trial of Camrelizumab for Injection in Combination With Famitinib Malate Capsule and Paclitaxel For Injection(Albumin Bound) in Advanced Solid Tumors of Patients

Advanced Solid Tumors Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05214976
• Other study ID #: SHR-1210-II-222
• Status: Enrolling by invitation
• Phase: Phase 2
• Start date: August 12, 2022
• Est. completion date: July 31, 2023

Study information

• Verified date: December 2022
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 64
• Est. completion date: July 31, 2023
• Est. primary completion date: January 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Solid Tumors
• Neoplasms

Intervention

Drug:
• Camrelizumab 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.

Locations

Country	Name	City	State
China	Shanghai Chest Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dose Limited Toxicity	Dose Limited Toxicity of Camrelizumab for Injection in combination with Famitinib malate capsule and Paclitaxel For Injection(Albumin Bound)	first dose of study medication up to 21 days]
Primary	Recommended phase II dose	The Recommended phase II dose of Camrelizumab for Injection in combination with Famitinib malate capsule and Paclitaxel For Injection(Albumin Bound)	first dose of study medication up to 21 days
Primary	ORR	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	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	DoR	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	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
Secondary	DCR	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	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
Secondary	PFS	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	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
Secondary	OS	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	from the date of the first dose to the date of death for any reason, up to 100 months
Secondary	12 months' survival 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	from the date of the first dose up to 12 months
Secondary	TTF	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	from the date of the first dose to the date of treatment termination, up to 6 months
Secondary	Incidence and severity of adverse events (AEs)/serious adverse events (SAEs)	Incidence and severity of adverse events (AEs)/serious adverse events (SAEs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0	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
Secondary	The occurrence rate of dose titration	The occurrence rate of dose interruption, dose decrease and dose termination because of study drug related toxicity during the study	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
Secondary	concentration of drug in serum	PK concentration of Camrelizumab for Injection	0.5 hour before first dose of Camrelizumab for Injection to 30 days after last dose
Secondary	concentration of drug in plasma	PK concentration of Famitinib malate capsule and its intermediate metabolite, and Paclitaxel For Injection(Albumin Bound)	2 days before first dose of Camrelizumab for Injection to 1 hour before the first dose of tenth cycle of Famitinib malate capsule
Secondary	Tmax	PK parameters of Famitinib malate capsule and its intermediate metabolite, and Paclitaxel For Injection(Albumin Bound)	2 days before first dose of Camrelizumab for Injection to 1 hour before the first dose of tenth cycle of Famitinib malate capsule
Secondary	Cmax	PK parameters of Famitinib malate capsule and its intermediate metabolite, and Paclitaxel For Injection(Albumin Bound)	2 days before first dose of Camrelizumab for Injection to 1 hour before the first dose of tenth cycle of Famitinib malate capsule
Secondary	AUC	PK parameters of Famitinib malate capsule and its intermediate metabolite, and Paclitaxel For Injection(Albumin Bound)	2 days before first dose of Camrelizumab for Injection to 1 hour before the first dose of tenth cycle of Famitinib malate capsule
Secondary	t1/2	PK parameters of Famitinib malate capsule and its intermediate metabolite, and Paclitaxel For Injection(Albumin Bound)	2 days before first dose of Camrelizumab for Injection to 1 hour before the first dose of tenth cycle of Famitinib malate capsule
Secondary	CL/F	PK parameters of Famitinib malate capsule and its intermediate metabolite, and Paclitaxel For Injection(Albumin Bound)	2 days before first dose of Camrelizumab for Injection to 1 hour before the first dose of tenth cycle of Famitinib malate capsule
Secondary	ADA	Anti-drug antibody, Immunogenicity of Camrelizumab for Injection	the date of first dose up to 30 days after last dose
Secondary	NAb	Neutralizing Antibody, Immunogenicity of Camrelizumab for Injection	the date of first dose up to 30 days after last dose