A Safety and Tolerability Study of INCAGN02390 in Select 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. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03652077|
Recruitment Status : Completed
First Posted : August 29, 2018
Last Update Posted : November 15, 2021
|Condition or disease||Intervention/treatment||Phase|
|Cervical Cancer Gastric Cancer Stomach Cancer Gastroesophageal Junction Cancer Esophageal Cancer Hepatocellular Carcinoma Melanoma Uveal Melanoma Merkel Cell Carcinoma Mesothelioma MSI Non-small Cell Lung Cancer NSCLC Ovarian Cancer Squamous Cell Carcinoma of the Head and Neck Small Cell Lung Cancer Renal Cell Carcinoma RCC Triple-negative Breast Cancer Urothelial Carcinoma Mismatch Repair Deficiency||Drug: INCAGN02390||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1, Open-Label, Dose-Escalation, Safety and Tolerability Study of INCAGN02390 in Participants With Select Advanced Malignancies|
|Actual Study Start Date :||September 24, 2018|
|Actual Primary Completion Date :||August 18, 2021|
|Actual Study Completion Date :||August 18, 2021|
Part 1: INCAGN02390 at the protocol-defined starting dose administered every 2 weeks (Q2W), with dose escalation in 7 total cohorts to determine the maximum tolerated dose or PAD.
- Number of treatment-emergent adverse events [ Time Frame: Up to 12 months ]Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug.
- Maximum tolerated dose or pharmacologically active dose (PAD) of INCAGN02390 (Part 1 only) [ Time Frame: Up to approximately 1 month ]PAD defined as a dose that achieves a level of receptor occupancy considered to be biologically active.
- Cmax of INCAGN02390 [ Time Frame: Up to 12 months ]Maximum observed plasma or serum concentration.
- Tmax of INCAGN02390 [ Time Frame: Up to 12 months ]Time to maximum concentration.
- Cmin of INCAGN02390 [ Time Frame: Up to 12 months ]Minimum observed plasma or serum concentration over the dose interval.
- AUC0-t of INCAGN02390 [ Time Frame: Up to 12 months ]Area under the plasma or serum concentration-time curve from time = 0 to the last measurable concentration at time = t.
- Objective response rate [ Time Frame: Up to 12 months ]Defined as the percentage of participants having complete response (CR) or partial response (PR) determined by investigator assessment of radiographic disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
- Duration of response [ Time Frame: Up to 12 months ]Defined as time from earliest date of disease response (CR or PR) until earliest date of disease progression (determined by investigator assessment of radiographic disease per RECIST v1.1) or death from any cause, if occurring sooner than progression.
- Disease control rate [ Time Frame: Up to 12 months ]Defined as percentage of participants having CR, PR, or stable disease as best on-study response.
- Progression-free survival [ Time Frame: Up to 12 months ]Defined as the time from date of first dose of study drug until the earliest date of disease progression (determined by investigator assessment of objective radiographic disease per RECIST v1.1) or death from any cause if occurring sooner than progression.
- Level of binding of INCAGN02390 to TIM-3 [ Time Frame: Up to approximately 3 months ]Assessed from participant whole blood samples.
- Immunogenicity of INCAGN02390 [ Time Frame: Up to 12 months ]Defined as the occurrence of specific ADA to INCAGN02390.
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): NCT03652077
|United States, California|
|The Angeles Clinical and Research Institute|
|Los Angeles, California, United States, 90025|
|United States, Mississippi|
|University of Mississippi|
|Jackson, Mississippi, United States, 39216|
|United States, New Jersey|
|Hackensack Medical Center|
|Hackensack, New Jersey, United States, 07601|
|United States, North Carolina|
|Huntsville, North Carolina, United States, 28078|
|Study Director:||Nawel Bourayou, MD||Incyte Corporation|