Evidence map›Paper›PMID 26961907›Full record

ArticleInvestigational new drugs2016

Phase I study of IMGN901, a CD56-targeting antibody-drug conjugate, in patients with CD56-positive solid tumors.

Manisha H Shah, Paul Lorigan, Mary E R O'Brien, Frank V Fossella, Kathleen N Moore, Shailender Bhatia, Maurice Kirby, Penella J Woll

Open access · hybridAbstract readClinical Trial, Phase IMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Article in Investigational new drugs, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 35 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
35citing papers in PubMed, 1 pooled it
3.9field-weighted citation impact, top 5% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

35 citing papers in PubMed, 1 synthesis or guideline pooled it, 63 citations in OpenAlex.

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  17. CAR T-Cell Therapy in Children with Solid Tumors.Journal of clinical medicine · 2023
    Review
  18. Review
  19. Antibody-Drug Conjugates for Melanoma and Other Skin Malignancies.Current treatment options in oncology · 2022
    Review
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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

8 authors at 8 institutions in 2 countries.

Manisha H ShahOhio State University College of Medicine, Columbus, OH, 43210, USA.
Paul LoriganUniversity of Manchester/Christie NHS Foundation Trust, Manchester, M20 4BX, UK.
Mary E R O'BrienRoyal Marsden Hospital, Sutton, Surrey, SM2 5PT, UK.
Frank V FossellaDepartment of Thoracic/Head and Neck Medical Oncology, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX, 77030, USA.
Kathleen N MooreUniversity of Oklahoma Health Sciences Center, Oklahoma City, OK, 73104, USA.
Shailender BhatiaDepartment of Medicine, University of Washington School of Medicine and Fred Hutchinson Cancer Research Center, Seattle, WA, 98109, USA.
Maurice KirbyImmunoGen, Inc., Waltham, MA, 02451, USA.
Penella J WollAcademic Unit of Clinical Oncology, Weston Park Hospital, University of Sheffield, Whitham Road, Sheffield, S10 2SJ, UK. p.j.woll@sheffield.ac.uk.
ImmunoGen (United States) · USRoyal Marsden Hospital · GBThe Ohio State University · USThe University of Texas MD Anderson Cancer Center · USUniversity of Manchester · GBUniversity of Oklahoma Health Sciences Center · USUniversity of Washington · USWeston Park Cancer Centre · GB

Funding

Cancer Research UK 20622Department of Health
6 · The paper itself

Abstract

Background IMGN901 is a CD56-targeting antibody-drug conjugate designed for tumor-selective delivery of the cytotoxic maytansinoid DM1. This phase 1 study investigated the safety, tolerability, pharmacokinetics, and preliminary activity of IMGN901 in patients with CD56-expressing solid tumors. Methods Patients were enrolled in cohorts of escalating IMGN901 doses, administered intravenously, on 3 consecutive days every 21 days. A dose-expansion phase accrued patients with small cell lung cancer (SCLC), Merkel cell carcinoma (MCC), or ovarian cancer. Results Fifty-two patients were treated at doses escalating from 4 to 94 mg/m(2)/day. The maximum tolerated dose (MTD) was determined to be 75 mg/m(2). Dose-limiting toxicities included fatigue, neuropathy, headache or meningitis-like symptoms, chest pain, dyspnea, and myalgias. In the dose-expansion phase (n = 45), seven patients received 75 mg/m(2) and 38 received 60 mg/m(2) for up to 21 cycles. The recommended phase 2 dose (RP2D) was established at 60 mg/m(2) during dose expansion. Overall, treatment-emergent adverse events (TEAEs) were experienced by 96.9 % of all patients, the majority of which were Grade 1 or 2. The most commonly reported Grade 3 or 4 TEAEs were hyponatremia and dyspnea (each 8.2 %). Responses included 1 complete response (CR), 1 clinical CR, and 1 unconfirmed partial response (PR) in MCC; and 1 unconfirmed PR in SCLC. Stable disease was seen for 25 % of all evaluable patients who received doses ≥60 mg/m(2). Conclusions The RP2D for IMGN901 of 60 mg/m(2) administered for 3 consecutive days every 3 weeks was associated with an acceptable tolerability profile. Objective responses were observed in patients with advanced CD56+ cancers.

Indexed as

Administration, IntravenousAdolescentAdultAgedAged, 80 and overAntibodies, MonoclonalAntineoplastic Agents, ImmunologicalCD56 AntigenDose-Response Relationship, DrugFemaleHumansMaleMaximum Tolerated DoseMaytansineMiddle AgedNeoplasmsAntibodies, MonoclonalAntineoplastic Agents, ImmunologicalCD56 Antigenlorvotuzumab mertansineMaytansineAntibody-drug conjugateCD56DM1IMGN901Lorvotuzumab mertansine

Identifiers

PMID26961907
PMCPMC4859861
OpenAlexW2301784755

What OpenQuestion holds

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LicenceCC BY
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Registered trials

None linked

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.