Breast Cancer Clinical Trial

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

Summary

JTX-8064-101 is a Phase 1/2, open label, dose escalation and dose expansion clinical study to determine the safety, tolerability, and recommended Phase 2 dose of JTX-8064 alone and in combination with a PD-1 inhibitor (PD-1i).

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Full 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 1/2, first in human, open label, multicenter, dose escalation and dose expansion clinical trial to determine the safety, tolerability, maximum tolerated dose (MTD) and RP2D of JTX-8064 when administered as a single agent and in combination with a PD-1i in adult subjects with advanced refractory solid tumor malignancies. Additionally, the study will seek to evaluate the pharmacokinetics and immunogenicity of JTX-8064, and preliminary efficacy of JTX-8064 as a monotherapy and in combination with a PD-1i.

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Eligibility Criteria

Inclusion Criteria:

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;

Histologically or cytologically confirmed advanced/metastatic extracranial solid tumor malignancy:

Stages 1 and 2: Subjects must have received, have been intolerant to, have been ineligible for, or have declined all treatment known to confer clinical benefit with the exception of subjects enrolled in combination cohorts with a PD-1i, where a PD-1i is approved by the local regulatory agencies;
Stage 3: This stage may enroll subjects with 3L/4L PD-(L)1-naïve, platinum-resistant ovarian cancer;

Stage 4: This stage may enroll subjects with the following cancers:

2L/3L ccRCC. Subjects must have progressed on or after treatment with an anti-PD-(L)1 agent in their most recent prior line of therapy;
2L-4L TNBC. Subjects must have progressed on or after treatment with a prior anti-PD-(L)1 therapy;
1L, PD-(L)1-naïve, PD-L1+; combined positive score (CPS) ≥1% HNSCC;
2L/3L platinum-experienced HNSCC. Subjects must have progressed on or after treatment with an anti-PD-(L)1-agent in their most recent prior line of therapy;
3L/4L, PD-(L)1-naïve, platinum-resistant ovarian cancer;
2L/3L NSCLC. Subjects must have progressed on or after treatment with platinum-based chemotherapy and an anti-PD-(L)1-containing therapy. The anti-PD-(L)1 agent must have been a part of the most recent prior line of therapy. Subjects with EGFR mutations and ALK rearrangements will be excluded. Subjects with other targetable genomic aberrations for which FDA approved therapies exist must have received appropriate FDA-approved targeted therapy;
2L/3L cSCC. Subjects must have progressed on or after treatment with an anti-PD-(L)1 agent in their most recent prior line of therapy;
2L-4L PD-(L)1-naïve undifferentiated pleomorphic sarcoma (UPS) and liposarcoma (LPS);
2L/3L biliary tract cancer (BTC), including intra- and extra-hepatic biliary duct cancer and cancer of the gallbladder. Subjects must have progressed on or after gemcitabine/cisplatin (Gem/Cis) in the metastatic setting and must have PD-(L)1 inhibitor resistance. Subjects with FGFR and IDH1 mutations must have progressed on or after targeted therapies for these mutations;
Measurable disease, according to the RECIST version 1.1, that has objectively progressed since (or on) previous treatment as assessed by the Investigator;
≥18 years of age;
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1;
Predicted life expectancy of ≥3 months;
Have specified laboratory values (obtained ≤28 days prior to planned Cycle 1, Day 1 [C1D1]) in accordance with the study protocol;
For women of childbearing potential (WOCBP): negative serum pregnancy test during the Screening period and a negative urine pregnancy test up to 24 hours in advance of C1D1;
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:

Concurrent anticancer treatment, either FDA approved or investigational, for the cancer being evaluated in this study or for prior malignancies. A past history of other malignancies is allowed as long as the subject is not receiving treatment other than hormonal therapy and, in the judgment of the Investigator, is unlikely to have a recurrence. Of note, concurrent malignancies that do not require treatment and are clinically stable are allowed;
Prior infusion of JTX-8064, LILRB2, or ILT4-directed therapy;

The therapies listed below within the specified timeframe or ongoing toxicity attributed to prior therapy that was >Grade 1 according to the NCI CTCAE, version 5.0. Exceptions: >Grade 1 toxicities that, in the opinion of the Investigator, should not exclude the subject (e.g., alopecia, Grade 2 neuropathy, hypo- or hyperthyroidism, or other endocrinopathies that are well controlled with hormone replacement) and are approved by the Medical Monitor:

Major surgery (excluding minor procedures, for example, placement of vascular access, gastrointestinal/biliary stent, biopsy) <4 weeks prior to planned C1D1;
Immunotherapy or biologic therapy <28 days prior to planned C1D1 or 5 half-lives, whichever is shorter;
Chemotherapy <21 days prior to planned C1D1, or <42 days for mitomycin or nitrosoureas or 5 half-lives, whichever is shorter;
Targeted small molecule therapy <14 days or 5 half-lives, whichever is shorter, prior to planned C1D1;
Hormonal or other adjunctive therapy for cancers other than the cancer under evaluation in this study that started <14 days prior to planned C1D1 are not permitted; however, antiestrogen therapy, bisphosphonates, somatostatin analogues, leuprolide, and denosumab are permitted if started ≥14 days prior to C1D1. Other hormonal treatments and/or treatment for stable cancers (other than the cancer being treated on-study) may also be permitted 1) if these therapies would not be expected to have any positive or negative effect on the cancer being treated and 2) if discussed with and approved by the Medical Monitor;
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 Any prior organ transplantation, including allogeneic or autologous stem cell transplantation;
History of intolerance, hypersensitivity, or treatment discontinuation due to Grade 3 or greater irAEs (related to prior immunotherapy);
Diagnosis of immunodeficiency, either primary or acquired, or treatment with immunosuppressive levels of systemic corticosteroids (equivalent to ≥10 mg prednisone per day) or any other form of immunosuppressive therapy within 7 days prior to planned C1D1. Exception: Inhaled, intra-articular, topical, or systemic corticosteroids (systemic only at doses intended for adrenal replacement) and doses of immunosuppressive agents used prophylactically for contrast allergies are permitted in the absence of active autoimmune disease;
Known severe intolerance or life-threatening hypersensitivity reactions to humanized mAbs or IV immunoglobulin preparations; any history of anaphylaxis; known allergy to any of the study medications, their analogues, or excipients (sodium acetate, sucrose, sodium chloride and polysorbate 80) in the various formulations of any agent;
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);
Active and clinically relevant bacterial, fungal, or viral infection, including known hepatitis A, B, or C, or HIV (testing not required);
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;
History of pneumonitis requiring treatment with corticosteroids, interstitial lung disease, or severe (≥Grade 3) radiation pneumonitis (excluding localized radiation pneumonitis);
History in the last 3 months of acute diverticulitis, intra-abdominal abscess, or gastrointestinal obstruction, unless approved by Medical Monitor;
Symptomatic cardiac or cerebrovascular disease that is unresponsive to surgical or medical management;
Medical or social condition that, in the opinion of the Investigator, might place the subject at increased risk, adversely affect compliance, or confound safety or other clinical study data interpretation;
Active disease requiring systemic immunosuppressive therapy;
Live vaccines ≤30 days of C1D1;
Deep vein thrombosis, pulmonary embolism (including asymptomatic pulmonary embolism identified on imaging), or other thromboembolic event within the 6 months preceding C1D1 for JTX-8064 monotherapy cohorts only.

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

190

Study ID:

NCT04669899

Recruitment Status:

Completed

Sponsor:

Jounce Therapeutics, Inc.

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There are 45 Locations for this study

See Locations Near You

University of Alabama at Birmingham
Birmingham Alabama, 35249, United States
Banner MD Anderson Cancer Center
Gilbert Arizona, 85234, United States
Arizona Clinical Research Center
Tucson Arizona, 85258, United States
University of Arkansas Medical Sciences
Little Rock Arkansas, 72205, United States
City of Hope
Duarte California, 91010, United States
California Cancer Associates for Research & Excellence, Inc.
La Jolla California, 92037, United States
University of California, San Diego
La Jolla California, 92093, United States
Cedars Sinai
Los Angeles California, 90048, United States
UC Irvine Medical Center
Orange California, 92868, United States
University of California, Davis
Sacramento California, 95817, United States
Yale University
New Haven Connecticut, 06519, United States
Georgetown University
Washington District of Columbia, 20057, United States
University of Florida
Gainesville Florida, 32610, United States
University of Miami - Sylvester Comprehensive Cancer Center
Miami Florida, 33136, United States
Adventist Health System/Sunbelt, Inc.
Orlando Florida, 32803, United States
Tampa General Hospital
Tampa Florida, 33606, United States
Augusta Oncology Associates - Wheeler Road
Augusta Georgia, 30909, United States
University of Chicago
Chicago Illinois, 60637, United States
Cancer Care Center of Decatur
Decatur Illinois, 62526, United States
University of Kentucky Chandler Medical Center (UKCMC)
Lexington Kentucky, 40536, United States
University of Michigan
Ann Arbor Michigan, 48109, United States
Barbara Ann Karmanos Cancer Center
Detroit Michigan, 48201, United States
Henry Ford Hospital
Detroit Michigan, 48202, United States
START Midwest -Cancer & Hematology Center of Western Michigan
Grand Rapids Michigan, 49546, United States
Regents of the University of Minnesota
Minneapolis Minnesota, 55455, United States
Weill Cornell
New York New York, 10021, United States
Mount Sinai
New York New York, 10029, United States
Montefiore Medical Center PRIME
New York New York, 10461, United States
Carolina BioOncology
Huntersville North Carolina, 28708, United States
Gabrail Cancer Center
Canton Ohio, 44718, United States
UC Health, LLC
Cincinnati Ohio, 45229, United States
Case Comprehensive Cancer Center
Cleveland Ohio, 44106, United States
University of Oklahoma Health Sciences Center
Oklahoma City Oklahoma, 73104, United States
Providence Portland Cancer Center
Portland Oregon, 97213, United States
Fox Chase Cancer Center
Philadelphia Pennsylvania, 19111, United States
Prisma Health
Greenville South Carolina, 29605, United States
Mary Crowley Cancer Research
Dallas Texas, 75230, United States
Oncology Consultants, P.A.
Houston Texas, 77024, United States
MD Anderson
Houston Texas, 77030, United States
Joe Arrington Cancer Research & Treatment Center
Lubbock Texas, 79410, United States
START Texas Accelerated Research Therapeutics
San Antonio Texas, 78229, United States
START Mountain Region
West Valley City Utah, 84119, United States
Seattle Cancer Care Alliance
Seattle Washington, 98331, United States
The Board of Regents of the University of Wisconsin
Madison Wisconsin, 53792, United States
Medical College of Wisconsin
Milwaukee Wisconsin, 53226, United States

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

190

Study ID:

NCT04669899

Recruitment Status:

Completed

Sponsor:


Jounce Therapeutics, Inc.

How clear is this clinincal trial information?

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