Evidence map›Paper›PMID 41857036›Full record

Trial reportNature communications2026

MDM2 Inhibition with Alrizomadlin (APG-115) in TP53 wild-type salivary gland cancers: a phase I clinical trial.

Alexander T Pearson, Jameel Muzaffar, Kedar Kirtane, Emily Bellile, Krithika Suresh, Ari J Rosenberg, Francis Worden, Christine H Chung, Everett Vokes, J Chad Brenner and 9 more

Registry-linked trialAbstract readClinical Trial, Phase IRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Nature communications, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03781986 (A Multicenter Phase I/II Trial of a Novel MDM2 Inhibitor), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
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.

NCT03781986 phase1 / phase2active not recruitingnot on this map

A Multicenter Phase I/II Trial of a Novel MDM2 Inhibitor (APG-115) in p53 Wild-type Salivary Gland Carcinoma

TypeinterventionalSponsorUniversity of Michigan Rogel Cancer CenterRan2019 to 2027Enrolled41ConditionsMalignant Salivary Gland Cancer, Salivary Gland CancerArmsAPG-115, Carboplatin
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. 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

19 authors.

Alexander T Pearson *University of Chicago Cancer Center, Chicago, IL, USA.ORCID http://orcid.org/0000-0003-2801-7456
Jameel Muzaffar *H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL, USA.
Kedar Kirtane *H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL, USA.
Emily BellileUniversity of Michigan Rogel Cancer Center, Ann Arbor, MI, USA.
Krithika SureshUniversity of Michigan Rogel Cancer Center, Ann Arbor, MI, USA.ORCID http://orcid.org/0000-0001-7785-3536
Ari J RosenbergUniversity of Chicago Cancer Center, Chicago, IL, USA.ORCID http://orcid.org/0000-0001-5908-0939
Francis WordenUniversity of Michigan Rogel Cancer Center, Ann Arbor, MI, USA.
Christine H ChungH. Lee Moffitt Cancer Center and Research Institute, Tampa, FL, USA.ORCID http://orcid.org/0000-0001-5199-4306
Everett VokesUniversity of Chicago Cancer Center, Chicago, IL, USA.
J Chad BrennerUniversity of Michigan Rogel Cancer Center, Ann Arbor, MI, USA.ORCID http://orcid.org/0000-0003-3238-1111
Apurva BhangaleUniversity of Michigan Rogel Cancer Center, Ann Arbor, MI, USA.ORCID http://orcid.org/0000-0001-7262-569X
Jon McHughUniversity of Michigan Rogel Cancer Center, Ann Arbor, MI, USA.
Kristy WarnerUniversity of Michigan Rogel Cancer Center, Ann Arbor, MI, USA.
Felipe NorUniversity of Michigan Rogel Cancer Center, Ann Arbor, MI, USA.
Jacques E NorUniversity of Michigan Rogel Cancer Center, Ann Arbor, MI, USA.
Keri InnesUniversity of Michigan Rogel Cancer Center, Ann Arbor, MI, USA.
Yifan ZhaiAscentage Pharma, Rockville, MD, USA.
Tommy FuAscentage Pharma, Rockville, MD, USA.
Paul L Swiecicki *University of Michigan Rogel Cancer Center, Ann Arbor, MI, USA. pswiecic@med.umich.edu.ORCID http://orcid.org/0000-0003-2286-3555

Funding

U.S. Department of Health & Human Services | NIH | National Cancer Institute (NCI) P3O CA046592U.S. Department of Health & Human Services | NIH | National Institute of Dental and Craniofacial Research (NIDCR) R01-DE021139
6 · The paper itself

Abstract

Preclinical studies have evaluated murine double minue 2 (MDM2) inhibitors as a treatment for adenoid cystic carcinoma (ACC), but clinical trials are lacking. This phase I trial (NCT03781986) assesses the safety and antitumor activity of an oral MDM2 inhibitor, alrizomadlin (APG-115), +/- carboplatin in TP53 wild type unresectable recurrent/metastatic salivary gland cancers (R/M SGC) with a planned 1:1 randomization to carboplatin chemotherapy. The co-primary endpoints are determination of dose-limiting toxicity (DLT) and response rate (RR) for alrizomadlin monotherapy +/- carboplatin. Secondary endpoints include safety, survival, and RR by tumor histology. After enrollment of 4 patients to combination therapy, the trial was modified to a single arm study of alrizomadlin monotherapy due to excess toxicity. 1 DLT was seen in the combination arm, all patients had ≥ G3 treatment related adverse events (TRAE). 37 patients were enrolled to alrizomadlin monotherapy. 3 DLTs were encountered, 67% of patients had ≥ G3 TRAE. The RR was 15% with median progression free survival 10.5 months. These findings demonstrate encouraging tolerability of alrizomadlin monotherapy with antitumor activity in patients with TP53 wild type SGC, especially ACC.

Indexed as

Antineoplastic AgentsCarcinoma, Adenoid CysticProto-Oncogene Proteins c-mdm2Salivary Gland NeoplasmsTumor Suppressor Protein p53AdultAgedAntineoplastic Combined Chemotherapy ProtocolsCarboplatinFemaleHumansMaleMiddle AgedAntineoplastic AgentsCarboplatinMDM2 protein, humanProto-Oncogene Proteins c-mdm2TP53 protein, humanTumor Suppressor Protein p53

Identifiers

PMID41857036
PMCPMC13168462

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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.