IBI397 or Combination Therapies in Patients With Advanced Malignancies

Advanced Malignancies Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05245916
• Other study ID #: CIBI397A101
• Status: Withdrawn
• Phase: Phase 1
• Start date: April 14, 2022
• Est. completion date: August 24, 2023

Study information

• Verified date: August 2023
• Source: Innovent Biologics (Suzhou) Co. Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 24, 2023
• Est. primary completion date: August 24, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion criteria:

• Have failed the standard treatment for locally advanced, recurrent or metastatic solid tumor or have failed at least the second line standard treatment (including autologous stem cell transplantation) or have failed the first line standard treatment and are not eligible for autologous stem cell transplantation

• Willing to and able to provide written informed consent for the trial and able to comply with protocol-specified visits and related procedures

• = 18 and = 75 years of age on the day of signing the informed consent

• Have a performance scale of 0 or 1 on the Eastern Cooperative Oncology Group Performance Status (ECOG PS)

• Subjects with solid tumor: Have at least one measurable or assessable lesion as defined by RECIST v1.1; Subjects with lymphoma: Have at least one measurable or assessable lesion as defined by Lugano2014 criteria

Exclusion Criteria:

• Has been previously exposed to any CD47 antibody, SIRPa antibody, or CD47/SIRPa 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

Related Conditions & MeSH terms

• Advanced Malignancies
• Neoplasms

Intervention

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
• 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
• 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

Locations

Country	Name	City	State
China	Tianjin Medical University Cancer Institute and Hospital	Tianjin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Innovent Biologics (Suzhou) Co. Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with treatment related AEs	Number of patients who experienced a treatment related AEs from the frist dose until 90 days after the last dose	Up to 90 days post last dose
Primary	Percentage of Subjects with Dose-Limiting Toxicities (DLTs)	To evaluate the safety and tolerability of IBI397 alone or in combination with Sintilimab	Up to 28 Days following first dose
Secondary	area under the plasma concentration-time curve (AUC)		Up to 90 days post last dose
Secondary	maximum concentration (Cmax)		Up to 90 days post last dose
Secondary	clearance (CL)		Up to 90 days post last dose
Secondary	volume of distribution (V)		Up to 90 days post last dose
Secondary	half-life (t1/2)		Up to 90 days post last dose
Secondary	anti-drug antibody (ADA)	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	Up to 90 days post last dose
Secondary	Objective response rate (ORR)	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	Up to 2 years after enrollment