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

NCT ID: NCT05214976

Last Updated: 2022-12-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-12
• Study Completion Date: 2023-07-31

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.

Conditions

Advanced Solid Tumors

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Single Group

Group Type: EXPERIMENTAL

Camrelizumab for Injection, Famitinib malate capsule, Paclitaxel For Injection(Albumin Bound)

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jiangsu HengRui Medicine Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

SHR-1210-II-222

Identifier Type: -

Identifier Source: org_study_id