JTX-2011 Alone and in Combination With Anti-PD-1 or Anti-CTLA-4 in Subjects With Advanced and/or Refractory Solid Tumors



Status:Recruiting
Conditions:Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:6/30/2018
Start Date:August 2016
End Date:December 2022
Contact:Manny Lazaro
Email:ICONIC@jouncetx.com

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Phase 1/2 Multicenter Trial of ICOS Agonist Monoclonal Antibody (mAb) JTX-2011 Alone and in Combination With Nivolumab, Ipilimumab, or Pembrolizumab in Adult Subjects With Advanced and/or Refractory Solid Tumor Malignancies

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.

Inclusion Criteria:

1. Must be willing and able to participate and comply with all trial requirements and
able to provide signed and dated informed consent prior to initiation of any trial
procedures

2. Evaluable or measurable disease, according to Response Evaluation Criteria in Solid
Tumors (RECIST) v1.1 criteria, and meet the requirements for the intended study cohort

3. Male or Female ≥ 18 years of age

4. Have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1.
Subjects with ECOG 2 may be considered for enrollment in Parts C, D, F, and H if
approved by Medical Monitor

5. Have a predicted life expectancy of ≥ 3 months

6. Have laboratory values (obtained ≤ 28 days prior to first infusion day) in accordance
with the study protocol

7. If medical history of the following, case should be reviewed by the Medical Monitor:
prior biliary tract disorders (as based on Hepatobiliary SOC high level terms of:
obstructive bile duct disorders, hepatic vascular disorders, structural and other bile
duct disorders) or portal hypertension and/or hepatic vascular disorders

8. Women of child-bearing potential (WOCBP) must have a negative serum pregnancy test at
screening and a negative urine pregnancy test prior to administration of each dose of
JTX-2011

9. WOCBP and males with partners of child-bearing potential must agree to use adequate
birth control throughout their participation and for 5 months following the last study
treatment

Exclusion Criteria:

1. Receiving concurrent anti-cancer treatment (excluding radiation therapy), either
approved or investigational

2. Have refused standard therapy

3. Have received anti-cancer therapies listed below within the specified timeframe, or
who have ongoing toxicity from prior therapy > Grade 1 according to the Common
Terminology for Adverse Events (CTCAE). Exceptions to this are: > Grade 1 toxicities
which 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.

1. Have received biologic therapy, including immunotherapy, < 28 days prior to C1D1;

2. Have received CAR-T therapy;

3. Have received chemotherapy < 21 days prior to C1D1, or < 42 days for mitomycin or
nitrosoureas;

4. Have received targeted small molecule therapy < 14 days prior to C1D1;

5. Have undergone organ transplantation including allogeneic or autologous stem-cell
transplantation, at any time;

4. Have undergone a major surgery (excluding minor procedures, e.g. placement of vascular
access, biopsy, etc.) < 6 months prior to the first day of study treatment, C1D1

5. Have a history of intolerance, hypersensitivity, or treatment discontinuation due to
severe immune adverse events on prior immunotherapy, or documented presence of
neutralizing anti-drug antibody to nivolumab, ipilimumab, or pembrolizumab. Subjects
who discontinued prior immunotherapies for immune-related adverse events that are
well-controlled with appropriate treatment may be enrolled if approved by the Medical
Monitor.

6. Have a diagnosis of immunodeficiency, either primary or acquired, or treatment with
systemic steroids or any other form of immunosuppressive therapy within 7 days prior
to C1D1. Exception: inhaled or topical steroids and adrenal replacement doses are
permitted in the absence of active autoimmune disease as well as a one-time dose of
immunosuppressive agents used prophylactically for contrast allergies

7. Have any active disease requiring systemic immunosuppressive treatment

8. Have known severe intolerance to or life-threatening hypersensitivity reactions to
humanized monoclonal antibodies 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 in the various
formulations of any agent

9. Are symptomatic or have uncontrolled brain metastases, leptomeningeal disease, or
spinal cord compression not definitively treated with surgery or radiation (brain
metastases that are stable and asymptomatic, either treated or untreated, will be
allowed)

10. Have current second malignancy at other sites, which requires treatment, or in the
judgement of the Investigator, may require treatment within the next year. Concurrent
malignancies that do not require treatment and are clinically stable are allowed. A
past history of other malignancies is allowed as long as the subject is not receiving
specific treatment other than hormonal therapy, and, in the judgement of the
Investigator, is unlikely to have a recurrence.

11. Have active and clinically relevant bacterial, fungal, or viral infection, including
known Hepatitis A, B, or C or human immunodeficiency virus (HIV) (testing not
required)

12. Have received live vaccines within past 30 days (inactivated vaccines are allowed;
seasonal vaccines should be up to date prior to first infusion day)

13. Women who are pregnant or breastfeeding

14. Have experienced symptomatic cardiac disease that is unresponsive to surgical or
medical management

15. Have any medical or social condition that, in the opinion of the Investigator, might
place a subject at increased risk, affect compliance, or confound safety or other
clinical trial data interpretation
We found this trial at
16
sites
500 Westchester Avenue
Harrison, New York 10604
Phone: 646-888-4593
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330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Phone: 617-975-7452
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Phone: 617-724-4000
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Seattle, Washington 98104
(206) 543-2100
Phone: 206-606-7551
Univ of Washington Founded in 1861 by a private gift of 10 acres in what...
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Phone: 617-632-4876
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Boston, MA
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Chicago, Illinois 60637
Phone: 773-702-2336
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Denver, Colorado 80218
Phone: 720-754-2610
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1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
Phone: 877-632-6789
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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Houston, TX
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Middletown, New Jersey 07748
Phone: 646-888-4593
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3322 West End Avenue
Nashville, Tennessee 37203
Phone: 615-514-2401
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20 York St, N20 York St,
New Haven, Connecticut 06520
(203) 688-4242
Phone: 203-737-5228
Yale-New Haven Hospital Relying on the skill and expertise of more than 4,500 university and...
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1275 York Ave
New York, New York 10021
(212) 639-2000
Phone: 646-888-4593
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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Palo Alto, California 94304
Phone: 650-721-4090
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660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Phone: 314-747-1864
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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San Antonio, Texas 78229
Phone: 210-593-5256
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Washington, District of Columbia 20007
Phone: 202-687-2111
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