Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 6 for:    JTX
Previous Study | Return to List | Next Study

Study of JTX 8064, as Monotherapy and in Combination With a PD-1 Inhibitor, in Adult Subjects With Advanced Refractory Solid Tumors

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: NCT04669899
Recruitment Status : Recruiting
First Posted : December 17, 2020
Last Update Posted : February 17, 2021
Sponsor:
Information provided by (Responsible Party):
Jounce Therapeutics, Inc.

Brief Summary:
JTX-8064-101 is a Phase 1, open label, dose escalation clinical study to determine the safety, tolerability, and recommended Phase 2 dose of JTX-8064 alone and in combination with either JTX-4014 or pembrolizumab.

Condition or disease Intervention/treatment Phase
Cancer Drug: JTX-8064 Drug: JTX-4014 Drug: Pembrolizumab Phase 1

Detailed Description:
JTX-8064 is a humanized mAb designed to block the interaction of LILRB2 with its known ligands, endogenous major histocompatibility complex class I (MHC I) molecules. This is a Phase 1, first in human, open label, multicenter, dose escalation clinical trial to determine the safety, tolerability, MTD and RP2D of JTX-8064 when administered as a single agent and in combination with JTX-4014 or pembrolizumab to adult subjects with advanced refractory solid tumor malignancies. Additionally, the study will seek to evaluate the pharmacokinetics and immunogenicity of JTX-8064.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 1 First-in-Human (FIH) Study of Leukocyte Immunoglobulin-Like Receptor B2 (LILRB2) Inhibitor Monoclonal Antibody (mAb) JTX-8064, as Monotherapy and in Combination With a Programmed Cell Death Receptor-1 (PD-1) Inhibitor, in Adult Subjects With Advanced Refractory Solid Tumor Malignancies
Actual Study Start Date : January 12, 2021
Estimated Primary Completion Date : July 2022
Estimated Study Completion Date : September 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Stage 1, Dose Escalation: JTX-8064 monotherapy dose escalation
Stage 1 will evaluate JTX-8064 monotherapy dose escalation by intravenous infusion
Drug: JTX-8064
Specified dose on specified days

Experimental: Stage 2, Dose Escalation: JTX-8064 in combination with JTX-4014 or pembrolizumab
Stage 2 will evaluate JTX-8064 dose escalation in combination with JTX-4014 or pembrolizumab by intravenous infusion
Drug: JTX-8064
Specified dose on specified days

Drug: JTX-4014
Specified dose on specified days

Drug: Pembrolizumab
Specified dose on specified days




Primary Outcome Measures :
  1. Incidence and severity of dose-limiting toxicities (DLTs), treatment-emergent adverse events (TEAEs), serious TEAEs, and discontinuation due to adverse events (AEs). [ Time Frame: up to 18 months ]
    Evaluated using National Cancer Institute (NCI) Common Technology Criteria for Adverse Events (CTCAE) version 5.0

  2. Determination of a RP2D for JTX-8064 monotherapy and in combination with JTX-4014 or pembrolizumab [ Time Frame: up to 12 months ]

Secondary Outcome Measures :
  1. Cmax (the maximum observed concentration) for JTX-8064 when administered as monotherapy or in combination with JTX-4014 or pembrolizumab, [ Time Frame: Cycle 1 and 3, pre-dose through 508 hours post-dose; Cycle 2 and 3 to 12, pre-dose and 1.5 hours post-dose (each cycle is 21 days) ]
  2. Tmax (time of maximum observed concentration) for JTX-8064 when administered as monotherapy or in combination with JTX-4014 or pembrolizumab, [ Time Frame: Cycle 1 and 3, pre-dose through 508 hours post-dose; Cycle 2 and 3 to 12, pre-dose and 1.5 hours post-dose (each cycle is 21 days) ]
  3. Cmin for JTX-8064 when administered as monotherapy or in combination with JTX-4014 or pembrolizumab, [ Time Frame: Cycle 1 and 3, pre-dose through 508 hours post-dose; Cycle 2 and 3 to 12, pre-dose and 1.5 hours post-dose (each cycle is 21 days) ]
  4. AUClast (area under the concentration-time curve from time 0 to the last measurable concentration) for JTX-8064 when administered as monotherapy or in combination with JTX-4014 or pembrolizumab, [ Time Frame: Cycle 1 and 3, pre-dose through 508 hours post-dose; Cycle 2 and 3 to 12, pre-dose and 1.5 hours post-dose (each cycle is 21 days) ]
  5. AUCtau (area under the concentration-time curve over the dosing interval) for JTX-8064 when administered as monotherapy or in combination with JTX-4014 or pembrolizumab, [ Time Frame: Cycle 1 and 3, pre-dose through 508 hours post-dose; Cycle 2 and 3 to 12, pre-dose and 1.5 hours post-dose (each cycle is 21 days) ]
  6. Cmax for JTX-4014 and pembrolizumab in combination with JTX-8064 [ Time Frame: Pre-and post-dose on Cycles 1 to 12 (each cycle is 21 days) ]
  7. Tmax for JTX-4014 and pembrolizumab in combination with JTX-8064 [ Time Frame: Pre-and post-dose on Cycles 1 to 12 (each cycle is 21 days) ]
  8. Cmin for JTX-4014 and pembrolizumab in combination with JTX-8064 [ Time Frame: Pre-and post-dose on Cycles 1 to 12 (each cycle is 21 days) ]
  9. Incidence of ADAs to JTX-8064 and, as appropriate, to JTX-4014 or pembrolizumab [ Time Frame: Pre-dose on Cycles 1 to 12 (each cycle is 21 days) ]
  10. Incidence of neutralizing antibodies (Nabs) to JTX-8064 and, as appropriate, to JTX-4014 or pembrolizumab [ Time Frame: Pre-dose on Cycles 1 to 12, (each cycle is 21 days) ]
  11. Receptor occupancy for LILRB2 on monocytes and neutrophils in whole blood [ Time Frame: For Stage 1, Cycles 1 and 3, pre-dose through 508 hours post-dose and Cycle 2, pre-dose and 1.5hr post-dose; For Stage 2, Cycles 1 to 3, pre-dose and 1.5 hours post-dose (each cycle is 21 days) ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Able and willing to participate and comply with all study requirements and provide signed and dated informed consent prior to initiation of any study procedures;
  2. Histologically or cytologically confirmed advanced/metastatic extracranial solid tumor malignancy. Subject must have received, have been intolerant to, have been ineligible for, or have declined all treatment known to confer clinical benefit;
  3. Able/measurable disease, according to the RECIST version 1.1, that has objectively progressed since (or on) previous treatment as assessed by the Investigator;
  4. ≥ 18 years of age;
  5. Eastern Cooperative Oncology Group performance status 0 or 1;
  6. Predicted life expectancy of ≥ 3 months;
  7. Have laboratory values (obtained ≤ 28 days prior to first infusion day) in accordance with the study protocol;
  8. For women of childbearing potential (WOCBP): negative serum pregnancy test within 72 hours prior to planned Cycle 1 Day 1 (C1D1) and a negative urine pregnancy test on C1D1;
  9. WOCBP and males whose partners are WOCBP must agree to use a highly effective method of birth control throughout their participation and for 5 months following the last study drug administration

Exclusion Criteria:

  1. Concurrent anticancer treatment, either Food and Drug Administration (FDA)-approved or investigational, for the cancer being evaluated in this study or for prior malignancies. Concurrent malignancies that do not require treatment and are clinically stable are allowed;
  2. Prior infusion of JTX-8064, LILRB2, or Immunoglobulin-like Transcript 4 (ILT4)-directed therapy;
  3. The therapies listed below within the specified timeframe:

    1. Immunotherapy or biologic therapy < 28 days prior to planned C1D1 or 5 half-lives, whichever is shorter.
    2. Chemotherapy < 21 days prior to planned C1D1, or < 42 days for mitomycin or nitrosoureas or 5 half-lives, whichever is shorter
    3. Targeted small molecule therapy < 14 days or 5 half-lives, whichever is shorter, prior to planned C1D1
    4. Radiation therapy < 21 days prior to planned C1D1. Exception: Limited (e.g., pain palliation) radiation therapy is allowed prior to and during study drug administration as long as there are no acute toxicities, any AE due to prior radiation therapy has recovered to < Grade 2, and the radiation is not administered to a target lesion
  4. Symptomatic or uncontrolled brain metastases, leptomeningeal disease, or spinal cord compression not definitively treated with surgery or radiation (brain metastases that are stable and asymptomatic after prior treatment will be allowed);
  5. Women who are pregnant or breastfeeding or who plan to become pregnant/breastfeed while on study; men who plan to father children during the study
  6. Live vaccines ≤ 30 days of C1D1

Information from the National Library of Medicine

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): NCT04669899


Contacts
Layout table for location contacts
Contact: Nancy Mota (857) 259-3840 nmota@jouncetx.com
Contact: Gosia Riley (857) 259-3840 griley@jouncetx.com

Locations
Layout table for location information
United States, Michigan
START Midwest -Cancer & Hematology Center of Western Michigan Recruiting
Grand Rapids, Michigan, United States, 49546
Contact: Study Coordinator    616-954-5552      
United States, Texas
MD Anderson Recruiting
Houston, Texas, United States, 77030
Contact: Study Coordinator    713-745-8922      
START Texas Accelerated Research Therapeutics Recruiting
San Antonio, Texas, United States, 78229
Contact: Study Coordinator    210-593-5916      
Sponsors and Collaborators
Jounce Therapeutics, Inc.
Investigators
Layout table for investigator information
Study Director: Johan Baeck, M.D Jounce Therapeutics, Inc.
Layout table for additonal information
Responsible Party: Jounce Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT04669899    
Other Study ID Numbers: JTX-8064-101
First Posted: December 17, 2020    Key Record Dates
Last Update Posted: February 17, 2021
Last Verified: February 2021

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jounce Therapeutics, Inc.:
JTX-8064
JTX-4014
LILRB2
ILT-4
PD-1
Immunotherapy
Immuno-oncology
Solid tumor Malignancies
Dose escalation
INNATE
Monotherapy
Combination Therapy
Additional relevant MeSH terms:
Layout table for MeSH terms
Pembrolizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents