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CancerPhase 1NCT03790488

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

A Phase 1 study testing JTX-4014 in people with Cancer, run by Jounce Therapeutics, Inc. at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cancer
What is being tested?
JTX-4014
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
4 sitesUnited States
Study dates
6 Dec 2018to 28 Feb 2023
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 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;
  • 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;
  • ≥ 18 years of age;
  • ECOG performance status 0 or 1;
  • Predicted life expectancy of ≥ 3 months;
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  • Have laboratory values (obtained ≤ 28 days prior to first infusion day) in accordance with the study protocol;
  • 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;
  • 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;
  • Subjects with medical history of the following must be discussed with the Medical Monitor:
  • 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).
  • Portal hypertension and/or hepatic vascular disorders.

Who cannot join

  • 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);
  • Prior receipt of a PD-1 or PD-L1 inhibitor mAb, including JTX-4014;
  • 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:
  • Major surgery < 4 weeks prior to planned C1D1;
  • Biologic therapy, including non-PD-1/PD-L1 inhibitor immunotherapy, < 28 days prior to planned C1D1;
  • Chemotherapy < 21 days prior to planned C1D1, or < 42 days for mitomycin or nitrosoureas;
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  • Targeted small molecule therapy < 14 days 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, with protocol-specified exceptions;
  • Radiation therapy < 21 days prior to planned C1D1, with protocol-specified exceptions;
  • Any prior organ transplantation, including allogeneic or autologous stem cell transplantation;
  • History of intolerance, hypersensitivity, or treatment discontinuation due to severe immune-related adverse events on prior non PD 1/PD L1 inhibitor immunotherapy;
  • 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;
  • 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;
  • Symptomatic or uncontrolled brain metastases, leptomeningeal disease, or spinal cord compression not definitively treated with surgery or radiation, with protocol-specified exceptions;
  • Active and clinically relevant bacterial, fungal, or viral infection, including known hepatitis A, B, C, or human immunodeficiency virus;
  • Receipt of live vaccines within 30 days of planned C1D1;
  • 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 radiation pneumonitis (excluding localized radiation pneumonitis);
  • Symptomatic ascites or pleural effusion;
  • History of acute diverticulitis, intra-abdominal abscess, gastrointestinal obstruction, or abdominal carcinomatosis;
  • 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.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • Sarah Cannon Research Institute at HealthONE

    Denver, Colorado, 80218

  • START Midwest - Cancer & Hematology Centers of Western Michigan

    Grand Rapids, Michigan, 49546

  • South Texas Accelerated Research Therapeutics (START)

    San Antonio, Texas, 78229

  • Florida Cancer Specialists - Sarasota Cattlemen

    Sarasota, Florida, 34232

Other trials in United States

About this study

Official title: 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).

Read the detailed description

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.

Conditions
Cancer
Being tested
JTX-4014
Keywords
Solid Tumor Malignancies, JTX-4014, Monoclonal Antibody (mAb), Programmed Cell Death Receptor-1 (PD-1), Immunotherapy, Immuno-oncology, Dose Escalation
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • JTX-4014Drug

    Also called PD-1 Inhibitor

    Specified dose on specified days

Study groups in NCT03790488
Study groupRoleWhat they receive
JTX-4014ExperimentalPhase 1 dose escalation of PD-1 inhibitor mAb JTX-4014 by intravenous infusion
Receives: Drug: JTX-4014

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. % subjects with adverse events (AEs)

    Measured: Approximately 12 months

  2. % subjects with serious adverse events (SAEs)

    Measured: Approximately 12 months

  3. % subjects with dose-limiting toxicities (DLTs)

    Measured: Approximately 12 months

  4. % subjects with changes from baseline in pro-inflammatory cytokines

    Measured: Approximately 12 months

  5. % subjects with clinically significant change from baseline in clinical laboratory tests

    Measured: Approximately 12 months

  6. Maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of JTX-4014

    Measured: Approximately 12 months

Secondary outcomes (8)

  1. Maximum measured concentration in serum (Cmax)

    Measured: Approximately 12 months

  2. Time from dosing to Cmax (Tmax)

    Measured: Approximately 12 months

  3. Area under the serum concentration-time curve (AUC)

    Measured: Approximately 12 months

  4. Last measurable concentration (Clast)

    Measured: Approximately 12 months

  5. Time to last measurable concentration (Tlast)

    Measured: Approximately 12 months

  6. Terminal half-life (t1/2)

    Measured: Approximately 12 months

  7. Accumulation ratio of JTX-4014

    Measured: Approximately 12 months

  8. Evaluate anti-drug antibodies (ADA) against JTX-4014

    Measured: Approximately 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Dec 2018
  2. Study start6 Dec 2018
  3. Primary completion2 Jul 2019
  4. Study completion28 Feb 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03790488
Sponsor's protocol ID
JTX-4014-101
Status last verified
Jun 2023
First submitted
21 Dec 2018
Last updated
3 Jul 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Papadopoulos KP, Lakhani N, Falchook GS, Riley G, Baeck J, Brown KS, Gordon G, Le L, Wang JS. Phase I, first-in-human trial of programmed cell death receptor-1 (PD-1) inhibitor, JTX-4014, in adult patients with advanced, refractory, solid tumors. Cancer Immunol Immunother. 2021 Mar;70(3):763-772. doi: 10.1007/s00262-020-02730-5. Epub 2020 Sep 28.

    PubMed 32989552

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing JTX-4014 in people with Cancer, run by Jounce Therapeutics, Inc. at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

% subjects with adverse events (AEs) (time frame: Approximately 12 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03790488, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2023.

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