Sym023 (Anti-TIM-3) in Patients With Advanced Solid Tumor Malignancies or Lymphomas
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03489343|
Recruitment Status : Recruiting
First Posted : April 5, 2018
Last Update Posted : June 11, 2019
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Cancer Solid Tumor Lymphoma||Drug: Sym023||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||48 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1, Open-Label, Multicenter Trial Investigating the Safety, Tolerability, and Preliminary Antineoplastic Activity of Sym023 (Anti-TIM-3) in Patients With Advanced Solid Tumor Malignancies or Lymphomas|
|Actual Study Start Date :||May 30, 2018|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||September 2020|
Sym023 will be administered at up to 7 planned dose levels.
Sym023 is a recombinant, fully human antibody that binds TIM-3 and induces activation of immune cells.
Other Name: Anti-TIM-3
- Assessment of treatment emergent adverse events (AEs) meeting DLT criteria. [ Time Frame: 24 months ]Assess the safety and tolerability of Sym023 on a Q2W schedule to establish the MTD and/or RP2D. Assessment based on the occurrence of AEs meeting DLT criteria measured during Cycle 1.
- Evaluation of the immunogenicity of Sym023. [ Time Frame: 24 months ]Serum sampling to assess the potential for anti-drug antibody (ADA) formation.
- Evaluation of objective response (OR) or stable disease (SD). [ Time Frame: 24 months ]Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1), Response Evaluation Criteria in Lymphomas 2017 (RECIL 2017), or Immunotherapeutics Response Evaluation Criteria in Solid Tumors (iRECIST), depending on tumor type.
- Time to progression (TTP) of disease. [ Time Frame: 24 months ]Based on time of enrollment to first evidence of progression on imaging studies, as assessed by RECIST v1.1, RECIL 2017, or iRECIST, depending on tumor type.
- Area under the concentration-time curve in a dosing interval (AUC). [ Time Frame: 24 months ]Will be estimated using non-compartmental methods and actual timepoints.
- Maximum concentration (Cmax) [ Time Frame: 24 months ]Will be derived from observed data.
- Time to reach maximum concentration (Tmax) [ Time Frame: 24 months ]Will be derived from observed data.
- Trough concentration (Ctrough) [ Time Frame: 24 months ]Will be derived from observed data.
- Terminal elimination half-life (T½) [ Time Frame: 24 months ]Will be estimated using non-compartmental methods and actual timepoints.
- Clearance (CL) [ Time Frame: 24 months ]Will be estimated using non-compartmental methods and actual timepoints.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03489343
|Contact: Ulla Holm Hansen, RN||+45 8838 email@example.com|
|United States, Michigan|
|South Texas Accelerated Research Therapeutics (START) Midwest||Recruiting|
|Grand Rapids, Michigan, United States, 49503|
|Contact: Kathy Estkowski, CCRP 616-954-5551 firstname.lastname@example.org|
|Contact: Yvette C. Cole, RN, BSN, OCN 616-389-1652 email@example.com|
|Principal Investigator: Nehal Lakhani, MD, PhD|
|United States, Texas|
|The University of Texas MD Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Anjali Raina 713-792-3238 firstname.lastname@example.org|
|Principal Investigator: Filip Janku, MD, PhD|
|San Antonio, Texas, United States, 78240|
|Contact: Sarah Gomez 210-595-5670|
|Principal Investigator: Anthony W Tolcher, MD|
|Princess Margaret Cancer Centre||Recruiting|
|Toronto, Ontario, Canada, M5G 2M9|
|Contact: Anna Spreafico, MD 416-946-4501 ext 4012|
|Principal Investigator: Anna Spreafico, MD|
|Principal Investigator:||Lillian Siu, MD, FRCPC||Princess Margaret Cancer Centre|