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PD-1 Inhibitor

JTX-4014 for Cancer

Phase 1

Waitlist Available

Research Sponsored by Jounce Therapeutics, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 12 months

Awards & highlights

Study Summary

This trial is testing a new cancer drug to see what the highest dose is that people can tolerate without serious side effects, and what the best dose is for people with advanced cancer that has not responded to other treatments.

Eligible Conditions

Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximately 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

% subjects with adverse events (AEs)

% subjects with changes from baseline in pro-inflammatory cytokines

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

+3 more

Secondary outcome measures

Accumulation ratio of JTX-4014

Area under the serum concentration-time curve (AUC)

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

+5 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: JTX-4014Experimental Treatment1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pimivalimab

Not yet FDA approved

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Jounce Therapeutics, Inc.Lead Sponsor

5 Previous Clinical Trials

566 Total Patients Enrolled

Elizabeth Trehu, MD, FACPStudy DirectorJounce Therapeutics, Inc.

1 Previous Clinical Trials

242 Total Patients Enrolled

Stew KrollStudy DirectorJounce Therapeutics, Inc.

4 Previous Clinical Trials

533 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there opportunities to join this clinical trial at present?

"Unfortunately, this medical trial is not recruiting at this time. It was posted on December 6th 2018 and last updated September 9th 2022. If you are looking for other studies to participate in, there are 2804 trials searching for malignancy patients and 3 clinical trials that involve JTX-4014 actively enrolling participants."

Answered by AI

Is this a pioneering research endeavor?

"Presently, JTX-4014 is the focus of 3 clinical trials operating across 43 municipal areas and 15 nations. The inaugural trial for J TX- 401 4 was conducted in 2018; this study was sponsored by Jounce Therapeutics, Inc., included 18 participants, and concluded Phase 1 drug approval. Since then 0 further trials have been completed."

Answered by AI

Could you please provide an overview of the prior trials that have been conducted utilizing JTX-4014?

"In 2018, JTX-4014 was initially tested at South Texas Accelerated Research Therapeutics (START). At present, none of its trials are complete; however, 3 active studies are underway in Grand Rapids."

Answered by AI

How many sites within the city are conducting this clinical trial?

"This clinical trial is being conduced by START Midwest - Cancer & Hematology Centers of Western Michigan in Grand Rapids, Michigan, Sarah Cannon Research Institute at HealthONE in Denver, Colorado and Florida Cancer Specialists - Sarasota Cattlemen in Sarasota, Florida as well as 4 other medical centres."

Answered by AI

What is the aggregate amount of individuals participating in this clinical experiment?

"This medical trial is no longer recruiting participants. First posted in December 2018 and last updated on September 2022, applicants should instead investigate the 2804 clinical studies currently enrolling patients suffering from cancer or explore the three active trials involving JTX-4014."

Answered by AI

Has the FDA granted clearance for JTX-4014?

"The limited amount of clinical data available on JTX-4014 leads our team at Power to assign it a safety rating of 1. This is due to the fact that the current trial stage is Phase 1, indicating minimal supporting evidence for its efficacy and safety."

Answered by AI

Recent research and studies

Cancer Immunology, ImmunotherapyJournal

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

Papadopoulos, Kyriakos P., Nehal Lakhani, Gerald S. Falchook, Gosia Riley, Johan Baeck, Karen S. Brown, Gilad Gordon, Lidya Le, and Judy S. Wang. 2020. “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 Immunology, Immunotherapy. Springer Science and Business Media LLC. doi:10.1007/s00262-020-02730-5.

clinicaltrials.govStudy

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

2018. "Study of a PD-1 Inhibitor (JTX-4014) in Subjects With Solid Tumor Malignancies". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03790488.