Evidence map›Paper›PMID 36656461›Full record

ArticleClinical hematology international2023

Phase I Study of Safety and Pharmacokinetics of RO7297089, an Anti-BCMA/CD16a Bispecific Antibody, in Patients with Relapsed, Refractory Multiple Myeloma.

Torben Plesner, Simon J Harrison, Hang Quach, Cindy Lee, Adam Bryant, Annette Vangsted, Jane Estell, Michel Delforge, Fritz Offner, Patrick Twomey and 8 more

Registry-linked trialOpen access · diamondAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Clinical hematology international, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04434469 (An Open-Label, Multicenter, Phase I Trial Evaluating The Safety And Pharmacokinetics Of Escalating Doses Of RO7297089 In Patients With Relapsed Or Refractory Multiple Myeloma), which is not on this map. Cited by 14 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed, 2 pooled it
6.1field-weighted citation impact, top 3% 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.

NCT04434469 phase1completednot on this map

An Open-Label, Multicenter, Phase I Trial Evaluating The Safety And Pharmacokinetics Of Escalating Doses Of RO7297089 In Patients With Relapsed Or Refractory Multiple Myeloma

TypeinterventionalSponsorGenentech, Inc.Ran2020 to 2022Enrolled27ConditionsRefractory Multiple Myeloma, Relapsed Multiple MyelomaArmsRO7297089
3 · Its place in the literature

Who cites it

14 citing papers in PubMed, 2 syntheses or guidelines pooled it, 21 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Review
  4. Quantification of total sBCMA in human plasma by peptide-level immunocapture LC-MS/MS.Journal of mass spectrometry and advances in the clinical lab · 2025
    Article
  5. Review
  6. Review
  7. Review
  8. Review
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  11. Immunotherapy of Multiple Myeloma: Current Status as Prologue to the Future.International journal of molecular sciences · 2023
    Review
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  14. 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

18 authors at 10 institutions in 4 countries.

Torben PlesnerVejle Hospital, University of Southern Denmark, Vejle, Denmark. Torben.Plesner@rsyd.dk.ORCID http://orcid.org/0000-0002-2340-6068
Simon J HarrisonPeter MacCallum Cancer Center, Royal Melbourne Hospital, Melbourne and Sir Peter MacCallum Dept of Oncology University of Melbourne, Parkville, Australia.
Hang QuachSt. Vincent's Hospital Melbourne, University of Melbourne, Melbourne, Australia.
Cindy LeeRoyal Adelaide Hospital, Adelaide, Australia.
Adam BryantLiverpool Hospital, Sydney, Australia.
Annette VangstedDepartment of Hematology, Rigshopitalet, Copenhagen, Denmark.
Jane EstellConcord Repatriation General Hospital, Concord, Australia.
Michel DelforgeUniversity Hospitals Leuven, Louvain, Belgium.
Fritz OffnerGhent University, Ghent, Belgium.
Patrick TwomeyGenentech, Inc., South San Francisco, CA, USA.
Voleak ChoeurngOslo Myeloma Center, Department of Hematology, Oslo University Hospital, Oslo, Norway.
Junyi LiGenentech, Inc., South San Francisco, CA, USA.
Robert HendricksGenentech, Inc., South San Francisco, CA, USA.
Shannon M RuppertGenentech, Inc., South San Francisco, CA, USA.
Teiko SumiyoshiGenentech, Inc., South San Francisco, CA, USA.
Karen MillerGenentech, Inc., South San Francisco, CA, USA.
Eunpi ChoGenentech, Inc., South San Francisco, CA, USA.
Fredrik SchjesvoldOslo Myeloma Center, Department of Hematology, Oslo University Hospital, Oslo, Norway.
Oslo University Hospital · NOConcord Repatriation General Hospital · AUGhent University Hospital · BEKU Leuven · BELiverpool Hospital · AURigshospitalet · DKRoyal Adelaide Hospital · AUThe Royal Melbourne Hospital · AUThe University of Melbourne · AUUniversity of Southern Denmark · DK

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionThis phase 1 trial assessed the safety, pharmacokinetics, and preliminary antitumor activity of RO7297089, an anti-BCMA/CD16a bispecific antibody.

methodsRO7297089 was administered weekly by intravenous infusion to patients with relapsed/refractory multiple myeloma. The starting dose was 60 mg in this dose-escalation study utilizing a modified continual reassessment method with overdose control model.

resultsOverall, 27 patients were treated at doses between 60 and 1850 mg. The maximally administered dose was 1850 mg due to excipients in the formulation that did not allow for higher doses to be used. The maximum tolerated dose was not reached. The most common adverse events irrespective of grade and relationship to the drug were anemia, infusion-related reaction, and thrombocytopenia. Most common treatment-related grade ≥ 3 toxicities were ALT/AST increase and reduced lymphocyte count. Pharmacokinetic studies suggested non-linear pharmacokinetics and target-mediated drug disposition, with a trend of approaching linear pharmacokinetics at doses of 1080 mg and higher. Partial response was observed in two patients (7%), minimal response in two patients (7%), and stable disease in 14 patients (52%).

conclusionsRO7297089 was well tolerated at doses up to 1850 mg, and the efficacy data supported activity of RO7297089 in multiple myeloma. Combination with other agents may further enhance its potential as an innate immune cell engager in multiple myeloma.

trial registrationClinicalTrials.gov: NCT04434469; Registered June 16, 2020; https://www. CLINICALTRIALS: gov/ct2/show/NCT04434469 .

Indexed as

BCMACD16aClinical trialMultiple myelomaRO7297089

Identifiers

PMID36656461
PMCPMC10063703
OpenAlexW4317437043

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.