Advanced Malignancies
Conditions
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
Interventions
DRUGIBI397
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
DRUGIBI397+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
DRUGIBI397+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
Sponsors
Innovent Biologics (Suzhou) Co. Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| clearance (CL) | Up to 90 days post last dose | — |
| volume of distribution (V) | Up to 90 days post last dose | — |
| area under the plasma concentration-time curve (AUC) | Up to 90 days post last dose | — |
| 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 |
| 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 |
| half-life (t1/2) | Up to 90 days post last dose | — |
| maximum concentration (Cmax) | Up to 90 days post last dose | — |
Countries
China
Outcome results
None listed