Evidence map›Paper›PMID 32989552›Full record

ArticleCancer immunology, immunotherapy : CII2021

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.

Kyriakos P Papadopoulos, Nehal Lakhani, Gerald S Falchook, Gosia Riley, Johan Baeck, Karen S Brown, Gilad Gordon, Lidya Le, Judy S Wang

Registry-linked trialAbstract readClinical Trial, Phase I
PubMed Full text at PMC Publisher
In one paragraph

Article in Cancer immunology, immunotherapy : CII, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03790488 (Phase 1 First in Human Study of Programmed Cell Death Receptor-1), which is not on this map. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03790488 phase1completednot on this map

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

TypeinterventionalSponsorJounce Therapeutics, Inc.Ran2018 to 2023Enrolled18ConditionsCancerArmsJTX-4014
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Review
  3. Article
  4. Article
  5. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

Kyriakos P PapadopoulosSouth Texas Accelerated Research Therapeutics (START), 4383 Medical Drive, Suite 4021, San Antonio, TX, 78229, USA. Kyri.Papadopoulos@startsa.com.ORCID http://orcid.org/0000-0002-0667-2620
Nehal LakhaniSTART Midwest, Grand Rapids, MI, USA.
Gerald S FalchookSarah Cannon Research Institute at HealthONE, Denver, CO, USA.
Gosia RileyJounce Therapeutics, Inc., Cambridge, MA, USA.
Johan BaeckJounce Therapeutics, Inc., Cambridge, MA, USA.
Karen S BrownJounce Therapeutics, Inc., Cambridge, MA, USA.
Gilad GordonJounce Therapeutics, Inc., Cambridge, MA, USA.
Lidya LeJounce Therapeutics, Inc., Cambridge, MA, USA.
Judy S WangFlorida Cancer Specialists/Sarah Cannon Research Institute, Sarasota, FL, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundInhibition of programmed cell death receptor protein-1 (PD-1) has proven to be a highly effective strategy for immunotherapy of cancer. Approvals of both PD-1 and PD-L1 inhibitors [PD-(L)1i] in multiple tumor types are evidence of the durable benefits they provide to patients with cancer. In this first-in-human trial, we assessed the safety and tolerability of JTX-4014, a fully human antibody targeting PD-1.

methodsJTX-4014 was administered to 18 patients with multiple solid tumor types who had not previously received a PD-(L)1i. The primary objectives were to evaluate the safety and tolerability of JTX-4014 and determine the maximum tolerated dose (MTD) and recommended phase II dose (RP2D). Secondary objectives included evaluation of the pharmacokinetics (PK) of JTX-4014, anti-drug antibodies (ADA) against JTX-4014, and clinical activity.

resultsJTX-4014 was well tolerated and no new safety signals were identified as compared with other PD-1is. The MTD was not reached and the RP2D was selected, based on PK modelling and supportive safety data, to be 500 mg every 3 weeks or 1000 mg every 6 weeks. Clinical activity, based on RECIST v1.1 criteria, demonstrated an overall response rate of 16.7% (n = 3) with one complete and two partial responses and a disease control rate of 44.4% (n = 8). The responses occurred at different doses in patients with PD-L1 positive tumors and in tumor types that are not typically PD-1i responsive.

conclusionsFurther development of JTX-4014 is warranted as a monotherapy or in combination with other innovative cancer therapies. TRIAL REGISTRATION NUMBER: NCT03790488, December 31 2018.

Indexed as

Molecular Targeted TherapyAntineoplastic Agents, ImmunologicalDrug MonitoringDrug Resistance, NeoplasmFemaleHumansMaleNeoplasm GradingNeoplasmsNeoplasm StagingProgrammed Cell Death 1 ReceptorTomography, X-Ray ComputedTreatment OutcomeAntineoplastic Agents, ImmunologicalProgrammed Cell Death 1 ReceptorImmunotherapyInvestigational therapiesProgrammed cell death 1 receptorSalivary gland tumorsTumor biomarkers

Identifiers

PMID32989552
PMCPMC7907044

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.