Evidence map›Paper›PMID 37265425›Full record

ArticleClinical cancer research : an official journal of the American Association for Cancer Research2023

Preclinical Characterization and Phase I Trial Results of INBRX-109, A Third-Generation, Recombinant, Humanized, Death Receptor 5 Agonist Antibody, in Chondrosarcoma.

Vivek Subbiah, Sant P Chawla, Anthony P Conley, Breelyn A Wilky, Anthony Tolcher, Nehal J Lakhani, David Berz, Vasily Andrianov, William Crago, Monica Holcomb and 9 more

2 registry-linked trialsOpen access · hybridAbstract readClinical Trial, Phase I
In one paragraph

Article in Clinical cancer research : an official journal of the American Association for Cancer Research, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 32 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
32citing papers in PubMed, 1 pooled it
9.7field-weighted citation impact, top 1% 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.

NCT03715933 phase1recruitingnot on this map

An Open-Label, Multicenter, First-in-Human, Phase 1 Dose-Escalation and Multicohort Expansion Study of INBRX-109 in Subjects With Locally Advanced or Metastatic Solid Tumors Including Sarcomas

TypeinterventionalSponsorInhibrx Biosciences, IncRan2018 to 2029Enrolled411ConditionsEwing Sarcoma, Colorectal AdenocarcinomaArmsINBRX-109, Irinotecan, Temozolomide, carboplatin, pemetrexed
NCT04950075 phase2active not recruitingnot on this map

A Randomized, Blinded, Placebo-controlled, Phase 2 Study of INBRX-109 in Unresectable or Metastatic Conventional Chondrosarcoma

TypeinterventionalSponsorInhibrx Biosciences, IncRan2021 to 2026Enrolled206ConditionsConventional ChondrosarcomaArmsINBRX-109, Placebo
3 · Its place in the literature

Who cites it

32 citing papers in PubMed, 1 synthesis or guideline pooled it, 40 citations in OpenAlex.

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  16. Phase I Study of the Mutant IDH1 Inhibitor Ivosidenib: Long-term Safety and Clinical Activity in Patients with Conventional Chondrosarcoma.Clinical cancer research : an official journal of the American Association for Cancer Research · 2025
    Article
  17. Article
  18. Understanding IgM Structure and Biology to Engineer New Antibody Therapeutics.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2025
    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

19 authors at 7 institutions in 1 country.

Vivek SubbiahDepartment of Investigational Cancer Therapeutics, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas; Sarah Cannon Research Institute, Nashville, Tennessee.ORCID 0000-0002-6064-6837
Sant P ChawlaSarcoma Oncology Research Center, Santa Monica, California.ORCID 0000-0002-9522-6744
Anthony P ConleyDepartment of Sarcoma Medical Oncology, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas.ORCID 0000-0002-6232-1163
Breelyn A WilkyDepartment of Medicine, Division of Medical Oncology, University of Colorado School of Medicine, Aurora, Colorado.ORCID 0000-0001-5080-497X
Anthony TolcherNEXT Oncology, San Antonio, Texas.ORCID 0000-0002-6322-9721
Nehal J LakhaniSTART Midwest, Michigan.ORCID 0009-0005-6327-0176
David BerzValkyrie Clinical Trials, Los Angeles, California.ORCID 0000-0001-8368-4601
Vasily AndrianovInhibrx, Inc, La Jolla, California.ORCID 0009-0005-1895-9126
William CragoInhibrx, Inc, La Jolla, California.ORCID 0009-0000-5838-4295
Monica HolcombInhibrx, Inc, La Jolla, California.ORCID 0009-0005-5298-7147
Abrahim HussainInhibrx, Inc, La Jolla, California.ORCID 0009-0000-3615-2581
Carson VeldstraInhibrx, Inc, La Jolla, California.ORCID 0009-0001-2809-0234
James KalabusInhibrx, Inc, La Jolla, California.ORCID 0000-0001-7582-8601
Brianne O'NeillInhibrx, Inc, La Jolla, California.ORCID 0009-0008-9224-952X
Lane SenneInhibrx, Inc, La Jolla, California.ORCID 0009-0005-3531-5840
Emily RowellInhibrx, Inc, La Jolla, California.ORCID 0009-0000-2630-2179
Analeah B HeidtInhibrx, Inc, La Jolla, California.ORCID 0009-0002-1096-7760
Katelyn M WillisInhibrx, Inc, La Jolla, California.ORCID 0009-0004-5741-4076
Brendan P EckelmanInhibrx, Inc, La Jolla, California.ORCID 0009-0006-7090-2642
Ambrx (United States) · USThe University of Texas MD Anderson Cancer Center · USLos Angeles Clinical Trials · USMidwest University · USSarcoma Oncology Center · USUniversity of Colorado Denver · USUrology San Antonio · US

Funding

Tumor Evolution and Metastasis ProgramP30CA016672 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI Scott Kopetz · 1985 to 2026
$290.8M
Center for Clinical and Translational Sciences (CCTS)UL1TR000371 · NCATS · UNIVERSITY OF TEXAS HLTH SCI CTR HOUSTON · PI MCPHERSON, DAVID D · 2012 to 2016
$13.4M
Discovery of the next-generation RET-targeted drugs based on nicotinamide scaffoldR01CA273168 · NCI · UNIVERSITY OF OKLAHOMA HLTH SCIENCES CTR · PI FUNDA MERIC-BERNSTAM, Herman O Sintim · 2022 to 2026
$2.9M
Blocking tumor progression in therapy-responsive RET aberration-associated cancerR01CA242845 · NCI · UNIVERSITY OF OKLAHOMA HLTH SCIENCES CTR · PI AHNERT, JORDI RODON, MOOERS, BLAINE H. M. · 2020 to 2024
$1.9M
Informatics to enable routine personalized cancer therapyU01CA180964 · NCI · UNIVERSITY OF TEXAS HLTH SCI CTR HOUSTON · PI BERNSTAM, ELMER V., MERIC-BERNSTAM, FUNDA · 2013 to 2015
$964k
NCATS NIH HHS UL1 TR000371NCI NIH HHS P30 CA016672NCI NIH HHS R01 CA242845NCI NIH HHS R01 CA273168NCI NIH HHS U01 CA180964
6 · The paper itself

Abstract

purposePatients with unresectable/metastatic chondrosarcoma have poor prognoses; conventional chondrosarcoma is associated with a median progression-free survival (PFS) of <4 months after first-line chemotherapy. No standard targeted therapies are available. We present the preclinical characterization of INBRX-109, a third-generation death receptor 5 (DR5) agonist, and clinical findings from a phase I trial of INBRX-109 in unresectable/metastatic chondrosarcoma (NCT03715933). PATIENTS AND

methodsINBRX-109 was first characterized preclinically as a DR5 agonist, with binding specificity and hepatotoxicity evaluated in vitro and antitumor activity evaluated both in vitro and in vivo. INBRX-109 (3 mg/kg every 3 weeks) was then evaluated in a phase I study of solid tumors, which included a cohort with any subtype of chondrosarcoma and a cohort with IDH1/IDH2-mutant conventional chondrosarcoma. The primary endpoint was safety. Efficacy was an exploratory endpoint, with measures including objective response, disease control rate, and PFS.

resultsIn preclinical studies, INBRX-109 led to antitumor activity in vitro and in patient-derived xenograft models, with minimal hepatotoxicity. In the phase I study, INBRX-109 was well tolerated and demonstrated antitumor activity in unresectable/metastatic chondrosarcoma. INBRX-109 led to a disease control rate of 87.1% [27/31; durable clinical benefit, 40.7% (11/27)], including two partial responses, and median PFS of 7.6 months. Most treatment-related adverse events, including liver-related events, were low grade (grade ≥3 events in chondrosarcoma cohorts, 5.7%).

conclusionsINBRX-109 demonstrated encouraging antitumor activity with a favorable safety profile in patients with unresectable/metastatic chondrosarcoma. A randomized, placebo-controlled, phase II trial (ChonDRAgon, NCT04950075) will further evaluate INBRX-109 in conventional chondrosarcoma.

Indexed as

Bone NeoplasmsChondrosarcomaReceptors, TNF-Related Apoptosis-Inducing LigandAntibodies, MonoclonalChemical and Drug Induced Liver InjuryHumansAntibodies, MonoclonalReceptors, TNF-Related Apoptosis-Inducing Ligand

Identifiers

PMID37265425
PMCPMC10425732
OpenAlexW4379094382

What OpenQuestion holds

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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.