A Phase 1, Open-label, Multicenter, Dose Escalation Study of IBI363 (PD1-IL2m) in Subjects with Advanced Solid Malignancies or Lymphomas
NCT ID: NCT05290597
Last Updated: 2024-12-18
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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RECRUITING
PHASE1
84 participants
INTERVENTIONAL
2022-08-22
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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IBI363
Single arm
IBI363
a mutated IL-2 cytokine fused to an anti-PD-1 antibody to combine IL-2 pathway stimulation with checkpoint blockade.
Interventions
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IBI363
a mutated IL-2 cytokine fused to an anti-PD-1 antibody to combine IL-2 pathway stimulation with checkpoint blockade.
Eligibility Criteria
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Inclusion Criteria
2. Subjects with a documented (histologically- or cytologically-proven) solid tumor malignancy that is locally advanced or metastatic; subjects with documented lymphomas
3. Subjects with a malignancy (solid tumor or lymphoma) that is currently not amenable to surgical intervention due to either medical contraindications or non-resectability of the tumor
4. Subjects who are refractory to or intolerant to existing therapy(ies) known to provide clinical benefit Note: Subjects may have received and failed prior therapy with a PD-1/PD-L1 inhibitor and be considered eligible for this trial.
5. Subjects with measurable or non-measurable disease according to RECIST v1.1 or standard criteria for lymphoma (Lugano 2014)
6. Subjects, both male and female, who are either not of childbearing potential or who agree to use a highly effective method of contraception during the study beginning within 2 weeks prior to the first dose and continuing until 6 months after the last dose of study drug
7. Subjects with the ability to understand and give written informed consent for participation in this trial, including all evaluations and procedures as specified by this protocol
Exclusion Criteria
2. Subjects with history of or known active seizure disorder, brain metastases, spinal cord compression, or carcinomatous meningitis, or new evidence of brain or leptomeningeal disease.
3. Subjects with:
* Active thrombosis, or a history of deep vein thrombosis (DVT) or pulmonary embolism (PE) within 4 weeks prior to first administration of study drug unless adequately treated and considered by the Investigator to be stable.
* Active uncontrolled bleeding or a known bleeding diathesis.
18 Years
ALL
No
Sponsors
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Fortvita Biologics (USA)Inc.
INDUSTRY
Innovent Biologics (Suzhou) Co. Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Morteza Aghmesheh
Role: PRINCIPAL_INVESTIGATOR
Southern Medical Day Care Centre
Locations
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Westmead Hospital
Sydney, New South Wales, Australia
Sydney Southwest Private Hospital
Sydney, New South Wales, Australia
Cancer Care Wollongong
Sydney, New South Wales, Australia
Countries
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Central Contacts
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Facility Contacts
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John Park
Role: primary
Mark Wong
Role: primary
Kate Wilkinson
Role: primary
Gary Tincknell
Role: primary
Other Identifiers
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CIBI363A101
Identifier Type: -
Identifier Source: org_study_id