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

Hengrui Medicine

Status and phase: Invitation-only; Phase 2

Conditions: Advanced Solid Tumors

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT05214976

SHR-1210-II-222

Details and patient eligibility

About

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.

Enrollment: 64 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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64 participants in 1 patient group

Single Group

Experimental group

Treatment:

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