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

NCT03790488 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: JTX-4014-101
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 4

Brief 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).

Conditions

Cancer

Keywords

Solid Tumor Malignancies; JTX-4014; Monoclonal Antibody (mAb); Programmed Cell Death Receptor-1 (PD-1); Immunotherapy; Immuno-oncology; Dose Escalation

Outcome Measures

Primary Outcomes (6)

• % subjects with adverse events (AEs)

  Approximately 12 months

• % subjects with serious adverse events (SAEs)

  Approximately 12 months

• % subjects with dose-limiting toxicities (DLTs)

  Approximately 12 months

• % subjects with changes from baseline in pro-inflammatory cytokines

  Approximately 12 months

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

  Approximately 12 months

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

  Approximately 12 months

Secondary Outcomes (8)

• Maximum measured concentration in serum (Cmax)

  Approximately 12 months

• Time from dosing to Cmax (Tmax)

  Approximately 12 months

• Area under the serum concentration-time curve (AUC)

  Approximately 12 months

• Last measurable concentration (Clast)

  Approximately 12 months

• Time to last measurable concentration (Tlast)

  Approximately 12 months

Study Arms (1)

JTX-4014

EXPERIMENTAL

Phase 1 dose escalation of PD-1 inhibitor mAb JTX-4014 by intravenous infusion

Drug: JTX-4014

Interventions

JTX-4014 DRUG

Specified dose on specified days

Also known as: PD-1 Inhibitor

JTX-4014

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• 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.

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• Jounce Therapeutics, Inc.: lead

Study Sites (4)

Sarah Cannon Research Institute at HealthONE

Denver, Colorado, 80218, United States

Location

Florida Cancer Specialists - Sarasota Cattlemen

Sarasota, Florida, 34232, United States

Location

START Midwest - Cancer & Hematology Centers of Western Michigan

Grand Rapids, Michigan, 49546, United States

Location

South Texas Accelerated Research Therapeutics (START)

San Antonio, Texas, 78229, United States

Location

Related Publications (1)

• 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.

  PMID: 32989552 DERIVED

MeSH Terms

Conditions

Neoplasms

Interventions

Immune Checkpoint Inhibitors

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Antineoplastic Agents, Immunological; Antineoplastic Agents; Therapeutic Uses

Study Officials

• Stew Kroll

  Jounce Therapeutics, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2018
• First Posted: December 31, 2018
• Study Start: December 6, 2018
• Primary Completion: July 2, 2019
• Study Completion: February 28, 2023
• Last Updated: July 3, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)