NCT03763149

A Study Evaluating the Safety, Tolerability, and Initial Efficacy of Recombinant Human Anti-cluster Differentiation Antigen 47 (CD47) Monoclonal Antibody Injection (IBI188) in Patients With Advanced Malignant Tumors and Lymphomas

A Phase 1a Study Evaluating the Safety, Tolerability, and Initial Efficacy of Recombinant Human Anti-cluster Differentiation Antigen 47 (CD47) Monoclonal Antibody Injection (IBI188) in Patients With Advanced Malignant Tumors and Lymphomas

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Innovent Biologics (Suzhou) Co. Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, dose escalation, Phase I study to evaluate the safety, tolerability, pharmacokinetics and efficacy in patients with advanced malignancies.

Detailed description

The study is composed of two stages: Part 1 Accelerated Titration Phase and Part 2 Dose Escalation Phase with initial fixed priming dose. The starting dose for part 1 is 0.1 mg/kg QW, followed by 2 dose cohorts (0.3 mg/kg QW and 1 mg/kg QW). Duration of dose limiting toxicity (DLT) observation is 28 days. Part 2 will have 4 dose cohorts(3mg/kg QW、10mg/kg QW、20mg/kg QW and 30mg/kg QW). Conventional 3+3 Dose Escalation will be adopted. DLT observation period is 28 days.

Conditions

• Advanced Malignancies

Interventions

Type	Name	Description
BIOLOGICAL	IBI188	The study is composed of two stages: Part 1 Accelerated Titration Phase and Part 2 Dose Escalation Phase with initial fixed priming dose. The starting dose for part 1 is 0.1 mg/kg QW, followed by 2 dose cohorts (0.3 mg/kg QW and 1 mg/kg QW). Duration of dose limiting toxicity (DLT) observation is 28 days. Part 2 will have 4 dose cohorts(3mg/kg QW、10mg/kg QW、20mg/kg QW and 30mg/kg QW). Conventional 3+3 Dose Escalation will be adopted. DLT observation period is 28 days.

Timeline

• Start date: 2019-02-19
• Primary completion: 2021-03-29
• Completion: 2021-03-29
• First posted: 2018-12-04
• Last updated: 2021-12-06

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study