Status:
RECRUITING
A Phase 1, Open-label, Multicenter, Dose Escalation Study of IBI363 (PD1-IL2m) in Subjects with Advanced Solid Malignancies or Lymphomas
Lead Sponsor:
Innovent Biologics (Suzhou) Co. Ltd.
Collaborating Sponsors:
Fortvita Biologics (USA)Inc.
Conditions:
Solid Malignancies or Lymphomas
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This is a Phase 1, open-label, multicenter, dose-escalation study designed to evaluate the safety, tolerability, and DLTs to establish the maximum tolerated dose (MTD) or maximum administered dose (MA...
Eligibility Criteria
Inclusion
- Male or female subjects, ≥ 18 years
- Subjects with a documented (histologically- or cytologically-proven) solid tumor malignancy that is locally advanced or metastatic; subjects with documented lymphomas
- 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
- 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.
- Subjects with measurable or non-measurable disease according to RECIST v1.1 or standard criteria for lymphoma (Lugano 2014)
- 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
- 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
- Women who are pregnant or lactating, or intending to become pregnant before, during, or within 6 months after the last dose of study drug. Women of childbearing potential (WOCBP) or fertile men with WOCBP partner(s), not using and not willing to use a highly effective method of contraception.
- 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.
- 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.
Key Trial Info
Start Date :
August 22 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT05290597
Start Date
August 22 2022
End Date
December 31 2026
Last Update
December 18 2024
Active Locations (4)
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1
Kate.Wilkinson1@health.nsw.gov.au
Sydney, New South Wales, Australia, 2109
2
Westmead Hospital
Sydney, New South Wales, Australia, 2145
3
Sydney Southwest Private Hospital
Sydney, New South Wales, Australia, 2170
4
Cancer Care Wollongong
Sydney, New South Wales, Australia, 2500