JTX-2011-101 is a Phase 1/2, open label, dose escalation and expansion clinical study of JTX-2011 alone and in combination with nivolumab, ipilimumab, or pembrolizumab in adult subjects with advanced and/or refractory solid tumors, to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D), as well as to evaluate preliminary efficacy.
JTX-2011 is an agonist monoclonal antibody that specifically binds to the Inducible CO-Stimulator of T cells (ICOS) to generate an anti-tumor immune response. This is a Phase 1/2, open label, multicenter, dose escalation and expansion, first-in-human (FIH) clinical study to evaluate the safety and tolerability, PK, PD, and preliminary efficacy of the ICOS agonist monoclonal antibody JTX-2011 alone and in combination with nivolumab, ipilimumab, or pembrolizumab in adult subjects with advanced and/or refractory solid tumors. The study will include a dose escalation phase for single agent and the combination therapies, followed by an expansion phase in specified tumor types for single agent and the combination therapies.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
242
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Stanford University School of Medicine
Palo Alto, California, United States
Sarah Cannon Research Institute at HealthONE
Denver, Colorado, United States
Number of Participants With Treatment Emergent Adverse Events (TEAE)
Number of participants with an adverse event occurring from the time of informed consent until resolution or new therapy initiated or for 28 days post final dose if no new therapy is initiated
Time frame: 46.3 months
Number of Participants With Grade 5 (Fatal) Treatment Emergent Adverse Events (TEAE)
Number of participants with Grade 5 (fatal) treatment emergent adverse events (TEAE) assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Time frame: 46.3 months
Number of Participants With Grade 4 (Life Threatening) Treatment Emergent Adverse Events (TEAE)
Number of participants with Grade 4 (life threatening) treatment emergent adverse events (TEAE) assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Time frame: 46.3 months
Number of Participants With Grade 3 (Sever) Treatment Emergent Adverse Events (TEAE)
Number of participants with Grade 3 (severe) treatment emergent adverse events (TEAE) assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.03."
Time frame: 46.3 months
Number of Participants With Grade 2 (Moderate) Treatment Emergent Adverse Events (TEAE)
Number of participants with Grade 2 (moderate) treatment emergent adverse events (TEAE) assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.03
Time frame: 46.3 months
Number of Participants With Grade 1 (Mild) Treatment Emergent Adverse Events (TEAE)
Number of participants with Grade 1 (mild) treatment emergent adverse events (TEAE) assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.03
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Specified dose on specified days
Yale New Haven Hospital
New Haven, Connecticut, United States
Georgetown Lombardi Comprehensive Cancer Center
Washington D.C., District of Columbia, United States
The University of Chicago Medicine Comprehensive Cancer Center
Chicago, Illinois, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Washington University School of Medicine
St Louis, Missouri, United States
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, United States
...and 6 more locations
Time frame: 46.3 months
Number of Participants With Dose Limiting Toxicities
Number of participants with at least one dose limiting toxicity (DLT)
Time frame: 33 months
Overall Response Rate
Overall response rate (ORR) is defined as the proportion of subjects with a Best Overall Response characterized as either a Complete Response (CR) or Partial Response (PR) as defined by RECISTv1.1 guidelines based on investigator's review
Time frame: 46.5 months
Disease Control Rate
Disease Control Rate: Percent Subjects with confirmed Complete Response + confirmed Partial Response + BoR of SD (or unconfirmed complete response or partial response lasting at least 53 days from the date of first dose)
Time frame: 46.5 months
Progression Free Survival
Progression free survival, as determined by the Investigator using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
Time frame: 46.5 months
6 Month Landmark Progression Free Survival
Percentage of patients that are progression free at 6 months, estimated by the Kaplan Meier method as the probability of being event-free at 6 months out of the entire 45.5-month primary study period. This method generates survival probability estimates across the Time Frame of the study using all data throughout the course of the trial.
Time frame: 46.5 months
12 Month Landmark Progression Free Survival
Percentage of patients that are progression free at 12 month, estimated by the Kaplan Meier method as the probability of being event-free at 12 months out of the entire 45.5-month primary study period. This method generates survival probability estimates across the Time Frame of the study using all data throughout the course of the trial.
Time frame: 46.5 months
Landmark Overall Survival at 6 Months
Percentage of patients that are alive at 6 month, estimated by the Kaplan Meier method as the probability of being event-free at 6 months out of the entire 45.5-month primary study period. This method generates survival probability estimates across the Time Frame of the study using all data throughout the course of the trial.
Time frame: 46.5 months
Landmark Overall Survival at 12 Months
Percentage of patients that are alive at 12 month, estimated by the Kaplan Meier method as the probability of being event-free at 12 months out of the entire 45.5-month primary study period. This method generates survival probability estimates across the Time Frame of the study using all data throughout the course of the trial.
Time frame: 46.5 months
Overall Survival
The time from first dose date to the date of death for any cause
Time frame: 46.5 months