IBI397 or Combination Therapies in Patients With Advanced Malignancies
NCT ID: NCT05245916
Last Updated: 2023-09-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE1
INTERVENTIONAL
2022-04-14
2023-08-24
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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IBI397 single-agent dose escalation
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+ Rituximab
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+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
IBI397 + Sintilimab
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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Innovent Biologics (Suzhou) Co. Ltd.
INDUSTRY
Responsible Party
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Locations
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Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China
Countries
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Other Identifiers
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CIBI397A101
Identifier Type: -
Identifier Source: org_study_id
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