IBI397 or Combination Therapies in Patients With Advanced Malignancies

Phase 1

Withdrawn

• Conditions: Advanced Malignancies
• Interventions: Drug: IBI397; Drug: IBI397+Sintilimab; Drug: IBI397+Rituximab

• Registration Number: NCT05245916
• Lead Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-01-26
• Study First Submitted QC: 2022-02-08
• Study First Posted: 2022-02-18
• Study Start: 2022-04-14
• Status Verified: 2023-08
• Primary Completion: 2023-08-24
• Study Completion: 2023-08-24
• Last Update Submitted: 2023-08-31
• Last Update Posted: 2023-09-05

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

• Has been previously exposed to any CD47 antibody, SIRPα antibody, or CD47/SIRPα recombinant protein or other inhibitors that target the same pathway
• Is currently participating in another interventional study, except for observational (non-interventional) study or in the survival follow-up phase of an interventional study
• Requires long-term systemic hormone or any other immunosuppressive drug therapy, excluding inhaled hormone therapy
• Has acute or chronic active hepatitis B (defined as hepatitis B surface antigen [HBsAg] and/or hepatitis B core antibody positive [HBcAb] and hepatitis B virus [HBV] DNA copy number ≥ 1 × 104 copies/ml or ≥ 2000 IU/ml or higher than the lower limit of detection) or acute or chronic active hepatitis C virus (HCV) antibody positive; HCV antibody positive but RNA negative subjects are allowed
• Has a known history of severe allergic reaction to other monoclonal antibodies, or is allergic to any component of the IBI397 formulation.
• Is pregnant or breastfeeding

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
IBI397 single-agent dose escalation	IBI397	-
IBI397 + Sintilimab	IBI397+Sintilimab	-
IBI397+ Rituximab	IBI397+Rituximab	-
IBI397 + Sintilimab	IBI397	-
IBI397+ Rituximab	IBI397	-

Primary Outcome Measures

Name	Time	Method
Percentage of Subjects with Dose-Limiting Toxicities (DLTs)	Up to 28 Days following first dose	To evaluate the safety and tolerability of IBI397 alone or in combination with Sintilimab
Number of patients with treatment related AEs	Up to 90 days post last dose	Number of patients who experienced a treatment related AEs from the frist dose until 90 days after the last dose

Secondary Outcome Measures

Name	Time	Method
area under the plasma concentration-time curve (AUC)	Up to 90 days post last dose
maximum concentration (Cmax)	Up to 90 days post last dose
clearance (CL)	Up to 90 days post last dose
half-life (t1/2)	Up to 90 days post last dose
volume of distribution (V)	Up to 90 days post last dose
Objective response rate (ORR)	Up to 2 years after enrollment	Objective Response Rate (ORR) is the percentage of Complete Response (CR) plus partial response (PR) assessed per RECIST v1.1 criteria for solid tumors or per Lugano2014 criteria for lymphomas
anti-drug antibody (ADA)	Up to 90 days post last dose	Number of Anti-Drug Antibodies (ADA) positive subjects will be counted and percentage of ADA positive subjects will be calculated to evaluate immunogenicity of IBI397

Trial Locations

Locations (1)

Tianjin Medical University Cancer Institute and Hospital; 🇨🇳 Tianjin, Tianjin, China