Evidence map›Paper›PMID 32207164›Full record

ArticleBritish journal of clinical pharmacology2020

Phase I study of imalumab (BAX69), a fully human recombinant antioxidized macrophage migration inhibitory factor antibody in advanced solid tumours.

Devalingam Mahalingam, Manish R Patel, Jasgit C Sachdev, Lowell L Hart, Niels Halama, Ramesh K Ramanathan, John Sarantopoulos, Dirk Völkel, Ashraf Youssef, Floris A de Jong and 1 more

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase I
In one paragraph

Article in British journal of clinical pharmacology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01765790 (A Phase 1 Open-Label Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Anti-MIF Antibody in Subjects With Malignant Solid Tumors), which is not on this map. Cited by 51 papers.

0numbers the graph read from it
0cells of the map it votes in
51citing papers in PubMed
2.8field-weighted citation impact, top 8% 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.

NCT01765790 phase1completednot on this map

A Phase 1 Open-Label Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Anti-MIF Antibody in Subjects With Malignant Solid Tumors

TypeinterventionalSponsorBaxalta now part of ShireRan2012 to 2016Enrolled68ConditionsMetastatic Adenocarcinoma of the Colon or Rectum, Malignant Solid TumorsArmsAnti-Macrophage Migration Inhibitory Factor (Anti-MIF) Antibody
3 · Its place in the literature

Who cites it

51 citing papers in PubMed, 76 citations in OpenAlex.

  1. Article
  2. Review
  3. Article
  4. Review
  5. Review
  6. Review
  7. Fragment Screening of MIF by Surface Plasmon Resonance.Methods in molecular biology (Clifton, N.J.) · 2026
    Article
  8. Role of Innate Oral Immunity and the Salivary Fluid in Inflammatory Bowel Disease.Cellular and molecular gastroenterology and hepatology · 2026
    Article
  9. Review
  10. Article
  11. Article
  12. Article
  13. Review
  14. Article
  15. Article
  16. Article
  17. Review
  18. Review
  19. Article
  20. Article
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

11 authors at 10 institutions in 5 countries.

Devalingam MahalingamUniversity of Texas Health Science Center, San Antonio, TX, USA.
Manish R PatelSarah Cannon Research Institute/Florida Cancer Specialists, Sarasota, FL, USA.
Jasgit C SachdevHonorHealth Research Institute/Translational Genomics Research Institute (TGen), Scottsdale, AZ, USA.
Lowell L HartFlorida Cancer Specialists, Fort Myers, FL, USA.
Niels HalamaNational Center for Tumor Diseases, University Medical Center Heidelberg, Heidelberg, Germany.
Ramesh K RamanathanMayo Clinic, Scottsdale, AZ, USA.
John SarantopoulosInstitute for Drug Development, Mays Cancer Center at University of Texas Health San Antonio MD Anderson Cancer Center, San Antonio, TX, USA.
Dirk VölkelBaxalta Innovations GmbH a member of the Takeda group of companies, Vienna, Austria.
Ashraf YoussefBaxalta US Inc. a member of the Takeda group of companies, Cambridge, MA, USA.
Floris A de JongShire International GmbH, a Takeda company, Zug, Switzerland.
Apostolia Maria TsimberidouDepartment of Investigational Cancer Therapeutics (Phase 1 Program), The University of Texas MD Anderson Cancer Center, Houston, TX, USA.ORCID 0000-0003-2713-233X
The University of Texas MD Anderson Cancer Center · USBaxalta (United States) · USBaxter (Austria) · ATFlorida Cancer Specialists & Research Institute · USHeidelberg University · DEMayo Clinic in Arizona · USNorthwestern University · USSarah Cannon · USTakeda (Switzerland) · CHTranslational Genomics Research Institute · US

Funding

Tumor Evolution and Metastasis ProgramP30CA016672 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI Fabien Delerue · 1985 to 2026
$290.8M
TISSUE CULTURE---COREP30CA054174 · NCI · UNIVERSITY OF TEXAS HLTH SCIENCE CENTER · PI Robin Jean Leach · 1991 to 2026
$59.1M
NCI NIH HHS P30 CA016672NCI NIH HHS P30 CA054174
6 · The paper itself

Abstract

aimPreclinical evidence suggests that oxidized macrophage migration inhibitory factor (oxMIF) may be involved in carcinogenesis. This phase 1 study (NCT01765790) assessed the safety, tolerability, pharmacokinetics and antitumour activity of imalumab, an oxMIF inhibitor, in patients with advanced cancer using '3 + 3' dose escalation.

methodsIn Schedule 1, patients with solid tumours received doses from 1 to 50 mg/kg IV every 2 weeks. In Schedule 2, patients with metastatic colorectal adenocarcinoma, non-small-cell lung, or ovarian cancer received weekly doses of 10 or 25 mg/kg IV (1 cycle = 28 days). Treatment continued until disease progression, unacceptable toxicity, dose-limiting toxicity, or withdrawal of consent.

resultsFifty of 68 enrolled patients received imalumab. The most common treatment-related adverse events (TRAEs) included fatigue (10%) and vomiting (6%); four grade 3 serious TRAEs (two patients) occurred. The dose-limiting toxicity was allergic alveolitis (one patient, 50 mg/kg every 2 weeks). The maximum tolerated and biologically active doses were 37.5 mg/kg every 2 weeks and 10 mg/kg weekly, respectively. Of 39 assessed patients, 13 had stable disease (≥4 months in 8 patients).

conclusionsImalumab had a maximum tolerated dose of 37.5 mg/kg every 2 weeks in patients with advanced solid tumours, with a biologically active dose of 10 mg/kg weekly. Further investigation will help define the role of oxMIF as a cancer treatment target.

Indexed as

Antineoplastic AgentsCarcinoma, Non-Small-Cell LungLung NeoplasmsMacrophage Migration-Inhibitory FactorsAntibodies, MonoclonalFemaleHumansMaleMaximum Tolerated DoseNeoplasmsTreatment OutcomeAntibodies, MonoclonalAntineoplastic AgentsMacrophage Migration-Inhibitory Factorsclinical trialspharmacokineticsphase I

Identifiers

PMID32207164
PMCPMC7444762
OpenAlexW3012934200

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

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.