COM902 (A TIGIT Inhibitor) in Subjects With Advanced Malignancies
|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: NCT04354246|
Recruitment Status : Recruiting
First Posted : April 21, 2020
Last Update Posted : April 21, 2020
|Condition or disease||Intervention/treatment||Phase|
|Advanced Cancer Ovarian Cancer Lung Cancer Colon Cancer Plasma Cell Neoplasm Breast Cancer||Drug: COM902||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||45 participants|
|Intervention Model:||Sequential Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1 Study of The Safety and Tolerability of COM902 in Subjects With Advanced Malignancies|
|Actual Study Start Date :||March 31, 2020|
|Estimated Primary Completion Date :||September 30, 2021|
|Estimated Study Completion Date :||September 30, 2022|
Experimental: COM902 Monotherapy Dose Escalation Arm.
Monotherapy Dose Escalation. COM902 monotherapy administered IV every 3 weeks in sequential dose escalation Cohorts using a rules-based design. Up to 7 dose escalation cohorts may be evaluated until a maximum tolerated dose or recommended phase 2 dose is identified.
COM902 monotherapy administered IV Q3 weeks in sequential dose escalation doses in cohorts of subjects.
- The safety and tolerability of COM902 monotherapy. [ Time Frame: DLT evaluation window in the 1st cycle (21 Days). ]Incidence of subjects with Adverse Events (AEs) as per CTCAE v5.0 and Dose-Limiting Toxicities (DLTs).
- To identify the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D). [ Time Frame: 18 months. ]Evaluation of preliminary antitumor activity of COM902.
- To characterize the pharmacokinetic (PK) profile of COM902 as monotherapy in subjects with advanced malignancies. [ Time Frame: 18 months. ]Evaluation of parameters of COM902 exposure such as Maximum Plasma Concentration [Cmax]) of COM902.
- To characterize the pharmacokinetic (PK) profile of COM902 as monotherapy in subjects with advanced malignancies. [ Time Frame: 18 months. ]Evaluation of parameters of COM902 exposure such as Area under the curve (AUC).
- To characterize immunogenicity of COM902 monotherapy [ Time Frame: 18 months. ]Evaluation of anti drug antibody to COM902.
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): NCT04354246
|Contact: Lead COM902 ClinInfo||+1 415 373 0781||COM902firstname.lastname@example.org|
|Contact: Backup COM902 ClinInfo||+1 415 373 0781||COM902email@example.com|
|United States, Michigan|
|Grand Rapids, Michigan, United States, 49503|
|Contact: COM902 Study Director 415-373-0781 COM902firstname.lastname@example.org|