IBI397 or Combination Therapies in Patients With Advanced Malignancies

NCT05245916 | Withdrawn Phase 1

• 1 other identifier: CIBI397A101
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Conditions

Advanced Malignancies

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• 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

Study Arms (3)

IBI397 single-agent dose escalation

EXPERIMENTAL

Drug: IBI397

IBI397+ Rituximab

EXPERIMENTAL

Drug: IBI397; Drug: IBI397+Rituximab

IBI397 + Sintilimab

EXPERIMENTAL

Drug: IBI397; Drug: IBI397+Sintilimab

Interventions

IBI397 DRUG

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 single-agent dose escalation; IBI397+ Rituximab

IBI397+Sintilimab DRUG

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 + Sintilimab

IBI397+Rituximab DRUG

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

IBI397+ Rituximab

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, 300200, China

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2022
• First Posted: February 18, 2022
• Study Start: April 14, 2022
• Primary Completion: August 24, 2023
• Study Completion: August 24, 2023
• Last Updated: September 5, 2023

Record last verified: 2023-08

Locations

CN (1)