NCT05245916

IBI397 or Combination Therapies in Patients With Advanced Malignancies

A Phase Ia/Ib Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of IBI397 or Combination Therapies in Patients With Advanced Malignancies

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Innovent Biologics (Suzhou) Co. Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this phase Ia/Ib Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of IBI397 or its Combination Therapies in Patients with Advanced Malignancies

Conditions

• Advanced Malignancies

Interventions

Type	Name	Description
DRUG	IBI397	IBI397 single-agent dose escalation： Subjects will receive IBI397 until disease progression, unacceptable toxicity, withdrawal of consent, occurrence of other conditions that require discontinuation of study treatment, or the treatment duration has reached 24 months, whichever occurs first
DRUG	IBI397+Sintilimab	IBI397 in combination with sintilimab： Subjects will receive IBI397 combination therapy with sintilimab until disease progression, unacceptable toxicity, withdrawal of consent, occurrence of other conditions that require discontinuation of study treatment, or the treatment duration has reached 24 months, whichever occurs first
DRUG	IBI397+Rituximab	IBI397 in combination with rituximab： Subjects will receive IBI397 combination therapy with rituximab until disease progression, unacceptable toxicity, withdrawal of consent, occurrence of other conditions that require discontinuation of study treatment, or the treatment duration has reached 24 months, whichever occurs first

Timeline

• Start date: 2022-04-14
• Primary completion: 2023-08-24
• Completion: 2023-08-24
• First posted: 2022-02-18
• Last updated: 2023-09-05

Locations

1 site across 1 country: China