NCT05164458

Safety and Efficacy of IBI389 Single Agent, and in Combination With Sintilimab, in Patients With Advanced Malignancies

A Phase Ia/Ib, Open Label, Multicenter Study of the Safety and Efficacy of IBI389 Single Agent, and in Combination With Sintilimab, Administered to Patients With Advanced Malignancies

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 320 (estimated)
• Sponsor: Innovent Biologics (Suzhou) Co. Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and anti-tumor activity of IBI389 as a single agent, and in combination with sintilimab, and (or) chemotherapy in patients with advanced or metastatic solid tumors.

Detailed description

The study consists of a dose escalation phase (Ia) and a dose expansion phase (Ib). Phase Ia is to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) for IBI389 as a single agent, and in combination with sintilimab. Phase (Ib) is a multi-cohort trial of CLDN18.2 positive solid tumors to evaluate safety and preliminary efficacy of IBI389 in combination with sintilimab and (or) chemotherapy or IBI389 monotherapy.

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	IBI 308 injection	IBI308 IV 200mg Q3W Day1
DRUG	IBI 389 Injection	IBI 389 IV Q2\~Q3W Day 1

Timeline

• Start date: 2022-03-22
• Primary completion: 2024-04-30
• Completion: 2024-09-30
• First posted: 2021-12-20
• Last updated: 2023-12-28

Locations

1 site across 1 country: China