Sym021 Monotherapy, in Combination With Sym022 or Sym023, and in Combination With Both Sym022 and Sym023 in Patients With Advanced Solid Tumor Malignancies or Lymphomas
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- 24
Summary
- Conditions
- Lymphoma
- Metastatic Cancer
- Solid Tumor
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: Non-RandomizedIntervention Model: Sequential AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
Part 1 of this study will evaluate the safety, tolerability, and dose-limiting toxicities (DLTs) to establish the maximum tolerated dose (MTD) and/or the selected dose of sequential escalating doses of Sym021 when administered once every 2 weeks (Q2W) by IV infusion to patient cohorts with locally a...
Part 1 of this study will evaluate the safety, tolerability, and dose-limiting toxicities (DLTs) to establish the maximum tolerated dose (MTD) and/or the selected dose of sequential escalating doses of Sym021 when administered once every 2 weeks (Q2W) by IV infusion to patient cohorts with locally advanced/unresectable or metastatic solid tumor malignancies or lymphomas that are refractory to available therapy or for which no standard therapy is available Part 2 of the study will evaluate the safety, tolerability, and DLTs to establish the MTD and/or the selected dose of sequential escalating doses of Sym022 when administered Q2W in combination with a fixed dose of 3 mg/kg of Sym021, each by IV infusion to patient cohorts with locally advanced/unresectable or metastatic solid tumor malignancies or lymphomas that are refractory to available therapy or for which no standard therapy is available Part 3 of the study will evaluate of the safety, tolerability, and DLTs to establish the MTD and/or the selected dose of sequential escalating doses of Sym023 when administered Q2W in combination with fixed doses of 3 mg/kg of Sym021 and either 1, 3 or 5 mg/kg of Sym022, each by IV infusion to patient cohorts with locally advanced/unresectable or metastatic solid tumor malignancies or lymphomas that are refractory to available therapy or for which no standard therapy is available.
Tracking Information
- NCT #
- NCT03311412
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Lillian Siu, MD, FRCPC Princess Margaret Cancer Centre