NCT03577704

The Safety,Efficacy of Anti-EGFR Humanized Monoclonal Antibody Combined With Chemotherapy in Advanced Solid Tumors.

An Exploratory Study on the Safety, Tolerability, Pharmacokinetics and Efficacy of HLX07 (Recombinant Anti-EGFR Humanized Monoclonal Antibody) Combined With Chemotherapy in Patients With Advanced Solid Tumors.

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Shanghai Henlius Biotech · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

HLX07 is a new anti-EGFR monoclonal antibody (mAb) with improved glycosylation pattern.In pre-clinical efficacy studies, HLX-07 is either equivalent or more potent than cetuximab in multiple cancer models without increased toxicities.This study is an open-labeled, dose-escalation study designed to explore the maximum tolerated dose (MTD) and safety of HLX07 in combination with different chemotherapy regimens.

Detailed description

This study is a parallel 3-arm escalation trial with 3 doses of HLX07 (400 mg, 600 mg, or 800 mg per single dose) combined with 3 different fixed-dose chemotherapy regimens. Three chemotherapy regimens are： ① Gemcitabine (1000 mg/m2) and Cisplatin (75 mg/m2) , every three weeks. Gemcitabine was administered on the first day and on the 8th day, and cisplatin 75 mg/m2 was administered on the first day , a total of 4-6 cycles。 ② Paclitaxel (80 mg/m2) and carboplatin (AUC=2), every 3 weeks. Paclitaxel and carboplatin were administered on days 1, 8 and 15 for a total of 4-6 cycles. ③ mFOLFOX6 protocol: oxaliplatin (85 mg/m2), leucovorin (400 mg/m2), and 5-fluouracil (5-FU) (400 mg/m2, followed by 2400 mg/m2), every 2 weeks. Oxaliplatin, leucovorin and 5-FU were administered on the first day. After 4 to 6 cycles of (gemcitabine and cisplatin regimens) and (the paclitaxel and carboplatin regimens) or after 6 to 12 cycles of the mFOLFOX6 regimen, well-controlled patients will be continue to receive a weekly HLX07 infusion as maintenance therapy for maximum 2 years or until disease progression or emergence of intolerable toxicity or permanent withdrawal or death (whichever comes first). The study used the Bayes optimal interval design (BOIN) to determine the MTD of HLX07 in combination with chemotherapy.

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	HLX07+Gemcitabine+Cisplatin	Recombinant anti-EGFR humanized monoclonal antibody in combination with Gemcitabine and Cisplatin. HLX07, IV, weekly.
DRUG	HLX07+Paclitaxel+Carboplatin	Recombinant anti-EGFR humanized monoclonal antibody in combination with Paclitaxel and Carboplatin. HLX07, IV, weekly.
DRUG	HLX07+mFOLFOX6	Recombinant anti-EGFR humanized monoclonal antibody in combination with Oxaliplatin, Calcium Folinate and 5-FU. HLX07, IV, weekly.

Timeline

• Start date: 2018-08-08
• Primary completion: 2022-09-30
• Completion: 2022-12-30
• First posted: 2018-07-05
• Last updated: 2023-04-12

Locations

1 site across 1 country: China