A Phase 1, Open-Label, Multicenter Trial Investigating the Safety, Tolerability, and Preliminary Antineoplastic Activity of Sym021 (Anti-PD-1) as Monotherapy, in Combination With Either Sym022 (Anti-LAG-3) or Sym023 (Anti-TIM-3), and in Combination With Both Sym022 and Sym023 in Patients With Advanced Solid Tumor Malignancies or Lymphomas

Who is this study for? Patients with advanced solid tumor malignancies or lymphomas

What treatments are being studied? Sym021

Status: Completed

Location: See all (4) locations...

Intervention Type: Drug

Study Type: Interventional

Study Phase: Phase 1

SUMMARY

The primary purpose of this study is to see if Sym021 is safe and tolerable as monotherapy, in combination with either Sym022 or Sym023, and in Combination with both Sym022 and Sym023 for patients 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.

Eligibility

Participation Requirements

Sex: All

Minimum Age: 18

Healthy Volunteers: f

View:

• Male or female patients, ≥ 18 years of age at the time of obtaining informed consent.

• Documented (histologically- or cytologically-proven) solid tumor malignancy that is locally advanced or metastatic; patients with documented lymphoma.

• Malignancy (solid tumor or lymphoma) that is currently not amenable to surgical intervention due to either medical contraindications or non-resectability of the tumor.

• Refractory to or intolerant of existing therapy(ies) known to provide clinical benefit.

• Measurable or non-measurable disease according to RECIST v1.1 or RECIL 2017.

• Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.

• Persons of childbearing potential agreeing 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(s); men agreeing to refrain from sperm donation during this period.

Locations

United States

Michigan

South Texas Accelerated Research Therapeutics (START) Midwest

Grand Rapids

Texas

The University of Texas MD Anderson Cancer Center

Houston

NEXT Oncology

San Antonio

Other Locations

Canada

Princess Margaret Cancer Centre

Toronto

Time Frame

Start Date: 2017-11-20

Completion Date: 2022-03-23

Participants

Target number of participants: 89

Treatments

Experimental: Sym021 Dose Level 1

Part 1, Sym021 monotherapy dose level 1

Experimental: Sym021 Dose Level 2

Part 1, Sym021 monotherapy dose level 2

Experimental: Sym021 Dose Level 3

Part 1, Sym021 monotherapy dose level 3

Experimental: Arm A: Sym021+Sym022 Dose Level 1

Part 2, Arm A: Sym021 RP2D in combination with dose level 1 of Sym022

Experimental: Arm A: Sym021+Sym022 Dose Level 2

Part 2, Arm A: Sym021 RP2D in combination with dose level 2 of Sym022

Experimental: Arm A: Sym021+Sym022 Dose Level 3

Part 2, Arm A: Sym021 RP2D in combination with dose level 3 of Sym022

Experimental: Arm A: Sym021+Sym022 Dose Level 4

Part 2, Arm A: Sym021 RP2D in combination with dose level 4 of Sym022

Experimental: Arm B: Sym021+Sym023 Dose Level 1

Part 2, Arm B: Sym021 RP2D in combination with dose level 1 of Sym023

Experimental: Arm B: Sym021+Sym023 Dose Level 2

Part 2, Arm B: Sym021 RP2D in combination with dose level 2 of Sym023

Experimental: Arm B: Sym021+Sym023 Dose Level 3

Part 2, Arm B: Sym021 RP2D in combination with dose level 3 of Sym023

Experimental: Arm B: Sym021+Sym023 Dose Level 4

Part 2, Arm B: Sym021 RP2D in combination with dose level 4 of Sym023

Experimental: Arm B: Sym021+Sym023 Dose Level 5

Part 2, Arm B: Sym021 RP2D in combination with dose level 5 of Sym023

Experimental: Sym021+Sym022+Sym023 Dose Level 1