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Monoclonal Antibodies
Sym021 for Lymphoma
Phase 1
Waitlist Available
Led By Lillian Siu, MD, FRCPC
Research Sponsored by Symphogen A/S
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
Summary
This trial is testing how safe and tolerable three different possible treatments are for patients with cancer that has spread or cannot be removed by surgery.
Eligible Conditions
- Cancer
- Solid Tumors
- Lymphoma
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Part 1: Assessment of treatment emergent adverse events (AEs) meeting DLT criteria.
Part 2: Assessment of treatment emergent adverse events (AEs) meeting DLT criteria.
Part 3: Assessment of treatment emergent adverse events (AEs) meeting DLT criteria.
Secondary outcome measures
Area under the concentration-time curve in a dosing interval (AUC)
Clearance (CL)
Evaluation of objective response (OR) or stable disease (SD).
+6 moreTrial Design
17Treatment groups
Experimental Treatment
Group I: Sym021+Sym022+Sym023 Dose Level 5Experimental Treatment3 Interventions
Part 3, Sym021 in combination with Sym022 and Sym023
Group II: Sym021+Sym022+Sym023 Dose Level 4Experimental Treatment3 Interventions
Part 3, Sym021 in combination with Sym022 and Sym023
Group III: Sym021+Sym022+Sym023 Dose Level 3Experimental Treatment3 Interventions
Part 3, Sym021 in combination with Sym022 and Sym023
Group IV: Sym021+Sym022+Sym023 Dose Level 2Experimental Treatment3 Interventions
Part 3, Sym021 in combination with Sym022 and Sym023
Group V: Sym021+Sym022+Sym023 Dose Level 1Experimental Treatment3 Interventions
Part 3, Sym021 in combination with Sym022 and Sym023
Group VI: Sym021 Dose Level 3Experimental Treatment1 Intervention
Part 1, Sym021 monotherapy dose level 3
Group VII: Sym021 Dose Level 2Experimental Treatment1 Intervention
Part 1, Sym021 monotherapy dose level 2
Group VIII: Sym021 Dose Level 1Experimental Treatment1 Intervention
Part 1, Sym021 monotherapy dose level 1
Group IX: Arm B: Sym021+Sym023 Dose Level 5Experimental Treatment2 Interventions
Part 2, Arm B: Sym021 RP2D in combination with dose level 5 of Sym023
Group X: Arm B: Sym021+Sym023 Dose Level 4Experimental Treatment2 Interventions
Part 2, Arm B: Sym021 RP2D in combination with dose level 4 of Sym023
Group XI: Arm B: Sym021+Sym023 Dose Level 3Experimental Treatment2 Interventions
Part 2, Arm B: Sym021 RP2D in combination with dose level 3 of Sym023
Group XII: Arm B: Sym021+Sym023 Dose Level 2Experimental Treatment2 Interventions
Part 2, Arm B: Sym021 RP2D in combination with dose level 2 of Sym023
Group XIII: Arm B: Sym021+Sym023 Dose Level 1Experimental Treatment2 Interventions
Part 2, Arm B: Sym021 RP2D in combination with dose level 1 of Sym023
Group XIV: Arm A: Sym021+Sym022 Dose Level 4Experimental Treatment2 Interventions
Part 2, Arm A: Sym021 RP2D in combination with dose level 4 of Sym022
Group XV: Arm A: Sym021+Sym022 Dose Level 3Experimental Treatment2 Interventions
Part 2, Arm A: Sym021 RP2D in combination with dose level 3 of Sym022
Group XVI: Arm A: Sym021+Sym022 Dose Level 2Experimental Treatment2 Interventions
Part 2, Arm A: Sym021 RP2D in combination with dose level 2 of Sym022
Group XVII: Arm A: Sym021+Sym022 Dose Level 1Experimental Treatment2 Interventions
Part 2, Arm A: Sym021 RP2D in combination with dose level 1 of Sym022
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sym022
2017
Completed Phase 1
~110
Sym023
2017
Completed Phase 1
~120
Sym021
2017
Completed Phase 1
~90
Find a Location
Who is running the clinical trial?
Symphogen A/SLead Sponsor
16 Previous Clinical Trials
761 Total Patients Enrolled
2 Trials studying Lymphoma
39 Patients Enrolled for Lymphoma
Lillian Siu, MD, FRCPCPrincipal InvestigatorPrincess Margaret Cancer Centre
3 Previous Clinical Trials
52 Total Patients Enrolled
2 Trials studying Lymphoma
39 Patients Enrolled for Lymphoma
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