Evidence map›Paper›PMID 32472319›Full record

ArticleInvestigational new drugs2020

Safety and efficacy of CDX-014, an antibody-drug conjugate directed against T cell immunoglobulin mucin-1 in advanced renal cell carcinoma.

Bradley A McGregor, Michael Gordon, Ronan Flippot, Neeraj Agarwal, Saby George, David I Quinn, Mark Rogalski, Thomas Hawthorne, Tibor Keler, Toni K Choueiri

Registry-linked trialOpen access · greenAbstract readClinical Trial, Phase IMulticenter Study
In one paragraph

Article in Investigational new drugs, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02837991 (A Phase l Open-Label, Dose Escalation and Cohort Expansion Study, to Assess the Safety and Activity of the Antibody-Drug Conjugate CDX-014 in Advanced or Metastatic Renal Cell Carcinoma), which is not on this map. Cited by 20 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed, 2 pooled it
1.9field-weighted citation impact, top 11% of its field
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.

NCT02837991 phase1terminatednot on this map

A Phase l Open-Label, Dose Escalation and Cohort Expansion Study, to Assess the Safety and Activity of the Antibody-Drug Conjugate CDX-014 in Advanced or Metastatic Renal Cell Carcinoma (RCC) and Advanced or Metastatic Ovarian Clear Cell Carcinoma (OCCC)

TypeinterventionalSponsorCelldex TherapeuticsRan2016 to 2018Enrolled16ConditionsRenal Cell Carcinoma (RCC), Clear-cell Renal Cell Carcinoma, Papillary Renal Cell Carcinoma, Kidney NeoplasmsArmsCDX-014
3 · Its place in the literature

Who cites it

20 citing papers in PubMed, 2 syntheses or guidelines pooled it, 34 citations in OpenAlex.

  1. Prevalence of antibody drug conjugated-induced nausea and vomiting (ADCINV) in patients with cancer.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2026
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  5. Advances in Systemic Therapy for Ovarian Cancer Over the Past Decade: A Clinical and Molecular Perspective.Medical science monitor : international medical journal of experimental and clinical research · 2025
    Review
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  11. Role of TIM-1 in the development and treatment of tumours.Frontiers in cell and developmental biology · 2024
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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

10 authors at 6 institutions in 1 country.

Bradley A McGregorDana-Farber Cancer Institute, Lank Center for Genitourinary Oncology, Boston, MA, USA.ORCID https://orcid.org/0000-0002-8298-0289
Michael GordonHonorHealth Research Institute, Scottsdale, AZ, USA.ORCID https://orcid.org/0000-0002-7679-9504
Ronan FlippotDana-Farber Cancer Institute, Lank Center for Genitourinary Oncology, Boston, MA, USA.ORCID https://orcid.org/0000-0003-0083-4753
Neeraj AgarwalUniversity of Utah Huntsman Cancer Institute, Salt Lake City, UT, USA.ORCID https://orcid.org/0000-0003-1076-0428
Saby GeorgeRoswell Park Comprehensive Cancer Center, Buffalo, NY, USA.ORCID https://orcid.org/0000-0002-0444-5870
David I QuinnUniversity of Southern California Norris Comprehensive Cancer Center, Los Angeles, CA, USA.ORCID https://orcid.org/0000-0002-1411-0417
Mark RogalskiCelldex Therapeutics, Inc., Hampton, NJ, USA.
Thomas HawthorneCelldex Therapeutics, Inc., Hampton, NJ, USA.
Tibor KelerCelldex Therapeutics, Inc., Hampton, NJ, USA.ORCID https://orcid.org/0000-0003-1757-4230
Toni K ChoueiriDana-Farber Cancer Institute, Lank Center for Genitourinary Oncology, Boston, MA, USA. Toni_Choueiri@dfci.harvard.edu.ORCID https://orcid.org/0000-0002-9201-3217
Celldex Therapeutics (United States) · USDana-Farber Cancer Institute · USHonorHealth · USRoswell Park Comprehensive Cancer Center · USUniversity of Southern California · USUniversity of Utah · US

Funding

USC/NORRIS COMPREHENSIVE CANCER CENTER (CORE) SUPPORTP30CA014089 · NCI · UNIVERSITY OF SOUTHERN CALIFORNIA · PI Fumito Ito · 1985 to 2026
$181.4M
NCTN - Network Lead Academic Participating Site: USCUG1CA180830 · NCI · UNIVERSITY OF SOUTHERN CALIFORNIA · PI Anthony Boutros El-Khoueiry, Amir Goldkorn · 2019 to 2026
$3.2M
NCI NIH HHS P30 CA014089NCI NIH HHS UG1 CA180830
6 · The paper itself

Abstract

CDX-014 is an antibody-drug conjugate directed against TIM-1, a surface marker highly expressed in renal cell carcinoma (RCC) and ovarian carcinoma. This phase I, first-in-human trial was conducted to evaluate the safety and preliminary activity of CDX-014 in patients with advanced refractory RCC, following a dose-escalation and dose expansion design. CDX-014 was administered intravenously at doses ranging from 0.15 to 2.0 mg/kg every 2 or 3 weeks until progression or unacceptable toxicity. Sixteen patients received at least one dose of CDX-014. The maximum tolerated dose was not identified. Most frequent adverse grade 1 or 2 adverse events included nausea (38%), fatigue, alopecia, elevation of AST and decreased appetite (25% each). Adverse events of grade 3 or more included hyperglycemia (19%), urosepsis (6%), and one multi-organ failure (6%) responsible for one treatment-related death. Two patients discontinued therapy for adverse events including fatigue grade 2 and urosepsis grade 4. CDX-014 showed antitumor activity with one prolonged partial response and a clinical benefit rate (objective response or stable disease >6 months) of 31%. The two patients that exhibited the most marked tumor shrinkage had high TIM-1 expression on tumor tissue. Overall, CDX-014 exhibited a manageable toxicity profile and early signs of activity, supporting further evaluation of antibody-drug conjugates in patients with advanced RCC and potentially other TIM-1 expressing cancers. Trial registration https://clinicaltrials.gov/ct2/show/NCT02837991 NCT02837991; July 20, 2016.

Indexed as

AgedAged, 80 and overAntineoplastic AgentsCarcinoma, Renal CellFemaleHepatitis A Virus Cellular Receptor 1HumansImmunoconjugatesKidney NeoplasmsMaleMiddle AgedTreatment OutcomeTumor BurdenAntineoplastic AgentsHAVCR1 protein, humanHepatitis A Virus Cellular Receptor 1ImmunoconjugatesAntibody-drug conjugateFirst-in-humanMetastatic renal cell carcinomaPhase 1 trialRenal cell carcinomaSalvage therapy

Identifiers

PMID32472319
PMCPMC7578086
OpenAlexW3029599698

What OpenQuestion holds

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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.