Clinical trial NCT05245916: IBI397 or Combination Therapies in Patients With Advanced Malignancies
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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Advanced Malignancies
Lead sponsor: Innovent Biologics (Suzhou) Co. Ltd.
Sponsor class: INDUSTRY
First posted: 2022-02-18
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Number of patients with treatment related AEs
timeFrame: Up to 90 days post last dose
measure: Percentage of Subjects with Dose-Limiting Toxicities (DLTs)
timeFrame: Up to 28 Days following first dose
Secondary outcomes:
measure: area under the plasma concentration-time curve (AUC)
timeFrame: Up to 90 days post last dose
measure: maximum concentration (Cmax)
timeFrame: Up to 90 days post last dose
measure: clearance (CL)
timeFrame: Up to 90 days post last dose
measure: volume of distribution (V)
timeFrame: Up to 90 days post last dose
measure: half-life (t1/2)
timeFrame: Up to 90 days post last dose
measure: anti-drug antibody (ADA)
timeFrame: Up to 90 days post last dose
measure: Objective response rate (ORR)
timeFrame: Up to 2 years after enrollment
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute and Hospital
state: Tianjin
Study officials:
References: