Study of a PD-1 Inhibitor (JTX-4014) in Subjects With Solid Tumor Malignancies



Status:Recruiting
Conditions:Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:1/2/2019
Start Date:December 6, 2018
End Date:December 2020
Contact:Gosia Riley
Email:JTX-4014-101@jouncetx.com

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Phase 1 First in Human Study of Programmed Cell Death Receptor-1 (PD-1) Inhibitor Monoclonal Antibody (mAb) JTX-4014 in Adult Subjects With Advanced Refractory Solid Tumor Malignancies

JTX-4014-101 is a Phase 1, open label, dose escalation clinical study of JTX-4014 in adult
subjects with advanced refractory solid tumor malignancies, to determine the maximum
tolerated dose (MTD) and recommended Phase 2 dose (RP2D).

JTX-4014 is a fully human IgG4 monoclonal antibody designed to specifically bind to PD-1 and
block its interaction with its ligands, PD-L1 and PD-L2, to augment anti-tumor T cell
activity. This is a Phase 1, first in human, open label, multicenter, dose escalation
clinical study to evaluate the safety, tolerability, and PK of JTX-4014 when administered as
a single agent to adult subjects with advanced refractory solid tumor malignancies. The
intent of this study will be to determine the MTD and RP2D.

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 extracranial solid tumor malignancy that is
recurrent, metastatic, or persistent after at least 1 line of standard therapy and
with no further standard treatment options that are likely to provide meaningful
clinical benefit;

3. Evaluable or measurable disease, according to the RECIST version 1.1, that has
objectively progressed since (or on) previous treatment as assessed by the
Investigator; while target lesions are not required, target lesions should be measured
if present;

4. ≥ 18 years of age;

5. ECOG 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;

10. Subjects with medical history of the following must be discussed with the Medical
Monitor:

1. Prior biliary tract disorders (as based on hepatobiliary system organ class high
level terms of: obstructive bile duct disorders, hepatic vascular disorders,
structural and other bile duct disorders).

2. Portal hypertension and/or hepatic vascular disorders.

Exclusion Criteria:

1. Concurrent anticancer treatment, either FDA-approved, palliative, or investigational
for the cancer being evaluated in this study or for other cancers (with
protocol-specified exceptions);

2. Prior receipt of a PD-1 or PD-L1 inhibitor mAb, including JTX-4014;

3. The therapies listed below within the specified timeframe or ongoing toxicity
attributed to prior therapy that was > Grade 1 according to the NCI CTCAE, with
protocol-specified exceptions:

1. Major surgery < 4 weeks prior to planned C1D1;

2. Biologic therapy, including non-PD-1/PD-L1 inhibitor immunotherapy, < 28 days
prior to planned C1D1;

3. Chemotherapy < 21 days prior to planned C1D1, or < 42 days for mitomycin or
nitrosoureas;

4. Targeted small molecule therapy < 14 days prior to planned C1D1;

5. Hormonal or other adjunctive therapy for cancers other than the cancer under
evaluation in this study that started < 14 days prior to planned C1D1, with
protocol-specified exceptions;

6. Radiation therapy < 21 days prior to planned C1D1, with protocol-specified
exceptions;

7. Any prior organ transplantation, including allogeneic or autologous stem cell
transplantation;

4. History of intolerance, hypersensitivity, or treatment discontinuation due to severe
immune-related adverse events on prior non PD 1/PD L1 inhibitor immunotherapy;

5. Diagnosis of immunodeficiency, either primary or acquired, or treatment with
immunosuppressive levels of systemic corticosteroids or any other form of
immunosuppressive therapy within 7 days prior to planned C1D1, with protocol-specified
exceptions;

6. Known severe intolerance or life-threatening hypersensitivity reactions to humanized
mAbs or intravenous immunoglobulin preparations; any history of anaphylaxis; prior
history of human anti-human antibody response; known allergy to any of the study
medications, their analogues, or excipients;

7. Symptomatic or uncontrolled brain metastases, leptomeningeal disease, or spinal cord
compression not definitively treated with surgery or radiation, with
protocol-specified exceptions;

8. Active and clinically relevant bacterial, fungal, or viral infection, including known
hepatitis A, B, C, or human immunodeficiency virus;

9. Receipt of live vaccines within 30 days of planned C1D1;

10. 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;

11. History of pneumonitis requiring treatment with corticosteroids, interstitial lung
disease, or severe radiation pneumonitis (excluding localized radiation pneumonitis);

12. Symptomatic ascites or pleural effusion;

13. History of acute diverticulitis, intra-abdominal abscess, gastrointestinal
obstruction, or abdominal carcinomatosis;

14. Symptomatic cardiac or cerebrovascular disease that is unresponsive to surgical or
medical management;

15. 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.
We found this trial at
4
sites
Grand Rapids, Michigan 49503
Phone: 616-954-5552
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Denver, Colorado 80218
Phone: 720-754-4650
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Denver, CO
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San Antonio, Texas 78229
Phone: 210-593-2574
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San Antonio, TX
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Sarasota, Florida 34232
Phone: 941-377-9993
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Sarasota, FL
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