NCT06933069

Safety and Tolerability of CMAB017 In Patients With Advanced Solid Tumors

A Multicenter, Open-label Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Profile and Preliminary Anti-tumor Activity of CMAB017 in Advanced Malignant Solid Tumors

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 55 (estimated)
• Sponsor: Taizhou Mabtech Pharmaceutical Co.,Ltd · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, open-lable phase Ia clinical study to evaluate the safety, tolerability, pharmacokinetic profile and preliminary antitumor activity of CMAB017 in advanced malignant solid tumors.

Detailed description

This is a multicenter, open-lable, phase Ia study of CMAB017 which is planned to enroll about 55 patients with advanced solid tumors. The study is divided into the core period and the extension period.The core period involves the first four administrations of the drug, divided into two cohorts: the Q3W cohort (administering once every three weeks) and the Q2W cohort (administering once every two weeks). The pharmacokinetic profile and immunogenicity after completing dose escalation and observation for a total of four administrations are to be evaluated. In the extension period, for those subjects with therapeutic effects and tolerable side effects, the drug administration is to be prolonged. Further observations are to be made on the long-term safety, pharmacokinetic characteristics, immunogenicity, and anti-tumor effects of the treatment.

Conditions

• Solid Malignancies

Interventions

Type	Name	Description
DRUG	CMAB017	CMAB017 was administered at a preset dose, and body weight was measured before each study dose; if body weight changed ≥10% from baseline, the dose should be recalculated. Administration was by intravenous infusion: for doses ≤1000 mg, intravenous infusion lasted 60±5 min; for doses \>1000 mg, intravenous infusion lasted 90±5 min.

Timeline

• Start date: 2025-06-09
• Primary completion: 2026-05-31
• Completion: 2026-05-31
• First posted: 2025-04-18
• Last updated: 2025-09-11

Locations

1 site across 1 country: China