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

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

Study Overview

• Status: Withdrawn
• Conditions: Advanced Malignancies
• Intervention / Treatment: Drug: IBI397; Drug: IBI397+Rituximab; Drug: IBI397+Sintilimab

• Study Type: Interventional
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Lili Tan; Phone Number: 15901474796; Email: lili.tan@innoventbio.com

Study Locations

• China
  • Tianjin
    • Tianjin, Tianjin, China, 300200
      • Tianjin Medical University Cancer Institute and Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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, 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IBI397 single-agent dose escalation	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
Experimental: IBI397+ Rituximab	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+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
Experimental: IBI397 + Sintilimab	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
volume of distribution (V)		Up to 90 days post last dose
half-life (t1/2)		Up to 90 days post last dose
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
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

Collaborators and Investigators

• Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): April 14, 2022
• Primary Completion (Actual): August 24, 2023
• Study Completion (Actual): August 24, 2023

Study Registration Dates

• First Submitted: January 26, 2022
• First Submitted That Met QC Criteria: February 8, 2022
• First Posted (Actual): February 18, 2022

Study Record Updates

• Last Update Posted (Actual): September 5, 2023
• Last Update Submitted That Met QC Criteria: August 31, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Physiological Effects of Drugs; Antirheumatic Agents; Antineoplastic Agents; Immunologic Factors; Antineoplastic Agents, Immunological; Rituximab
• Other Study ID Numbers: CIBI397A101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No