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

NCT05214976 | Unknown Phase 2

• 1 other identifier: SHR-1210-II-222
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• 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]

• 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

• 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 Outcomes (17)

• 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

• 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

• 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

• OS

  from the date of the first dose to the date of death for any reason, up to 100 months

• 12 months' survival rate

  from the date of the first dose up to 12 months

Study Arms (1)

Single Group

EXPERIMENTAL

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

Interventions

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

Single Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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;
• The imaging examinations shows significant pulmonary cavitary tumors occurs with the bleeding risk as the investigator's assessment;
• patients with active brain metastasis (without medical control or with clinical symptoms), cancerous meningitis, or spinal cord compression;
• Uncontrollable pleural effusion, pericardial effusion or peritoneal effusion, with clinical symptoms;
• Severe bong injury caused by metastatic tumor of bone;
• Prior malignancy (other than current malignant tumor) within 3 years before the first dose of study treatment;
• History of autoimmune diseases;
• Evidence or history of arterial/venous thrombosis within 6 months before the first dose;
• Patients with interstitial pneumonitis or interstitial lung disease; past history of interstitial pneumonitis or interstitial lung disease requiring hormone therapy;
• 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.

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, 200030, China

Location

MeSH Terms

Interventions

camrelizumab; Injections; Paclitaxel

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Camrelizumab for Injection in combination with Famitinib malate capsule and Paclitaxel

Study Record Dates

• First Submitted: January 28, 2022
• First Posted: January 31, 2022
• Study Start: August 12, 2022
• Primary Completion: January 31, 2023
• Study Completion: July 31, 2023
• Last Updated: December 22, 2022

Record last verified: 2022-12

Locations

CN (1)