Evidence map›Paper›PMID 38036720›Full record

ArticleCancer chemotherapy and pharmacology2024

Pharmacokinetics and immunogenicity of eftozanermin alfa in subjects with previously-treated solid tumors or hematologic malignancies: results from a phase 1 first-in-human study.

Carla Biesdorf, Xiaowen Guan, Satya R Siddani, David Hoffman, Nils Boehm, Bruno C Medeiros, Toshihiko Doi, Maja de Jonge, Drew Rasco, Rajeev M Menon and 1 more

Registry-linked trialOpen access · greenAbstract readClinical Trial, Phase I
PubMed Publisher
In one paragraph

Article in Cancer chemotherapy and pharmacology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03082209 (An Open-Label, Phase 1, First-In-Human Study of TRAIL Receptor Agonist ABBV-621 in Subjects With Previously-Treated Solid Tumors and Hematologic Malignancies), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.5field-weighted citation impact, top 32% 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.

NCT03082209 phase1completednot on this map

An Open-Label, Phase 1, First-In-Human Study of TRAIL Receptor Agonist ABBV-621 in Subjects With Previously-Treated Solid Tumors and Hematologic Malignancies

TypeinterventionalSponsorAbbVieRan2017 to 2022Enrolled153ConditionsAdvanced Solid Tumors, Cancer, Hematologic MalignanciesArmsABBV-621, Venetoclax, Bevacizumab, FOLFIRI
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 3 citations in OpenAlex.

  1. Review
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  3. 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 5 institutions in 4 countries.

Carla BiesdorfClinical Pharmacology, AbbVie Inc., 1 North Waukegan Road, Bldg. AP31-3, North Chicago, IL, 60064, USA. carla.biesdorfdealmeida@abbvie.com.ORCID 0000-0002-6879-6557
Xiaowen GuanAbbVie Biotherapeutics Inc., South San Francisco, CA, USA.ORCID 0000-0002-2286-0920
Satya R SiddaniClinical Pharmacology, AbbVie Inc., 1 North Waukegan Road, Bldg. AP31-3, North Chicago, IL, 60064, USA.
David HoffmanClinical Pharmacology, AbbVie Inc., 1 North Waukegan Road, Bldg. AP31-3, North Chicago, IL, 60064, USA.
Nils BoehmAbbVie Inc., Ludwigshafen, Germany.
Bruno C MedeirosAbbVie Biotherapeutics Inc., South San Francisco, CA, USA.
Toshihiko DoiNational Cancer Center Hospital East, Kashiwa, Chiba, Japan.
Maja de JongeErasmus Medisch Centrum, Rotterdam, The Netherlands.
Drew RascoSouth Texas Accelerated Research Therapeutics (START), San Antonio, TX, USA.
Rajeev M MenonClinical Pharmacology, AbbVie Inc., 1 North Waukegan Road, Bldg. AP31-3, North Chicago, IL, 60064, USA.ORCID 0000-0002-2945-0449
Akshanth R PolepallyAbbVie Biotherapeutics Inc., South San Francisco, CA, USA.ORCID 0000-0002-5938-6062
AbbVie (United States) · USAbbVie (Germany) · DEErasmus University Rotterdam · NLNational Cancer Center Hospital East · JPSouth Texas Accelerated Research Therapeutics · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeEftozanermin alfa is a second-generation tumor necrosis factor-related apoptosis-inducing ligand (TRAIL) receptor agonist that enhances death receptor 4/5 clustering on tumor cells to induce apoptosis. We report the pharmacokinetics and immunogenicity of eftozanermin alfa administered intravenously to 153 adults with previously-treated solid tumors or hematologic malignancies from the first-in-human, open-label, dose-escalation and dose-optimization study.

methodsDose escalation evaluated eftozanermin alfa monotherapy 2.5-15 mg/kg on Day 1 or Days 1/8 of a 21-day cycle. Dose optimization evaluated eftozanermin alfa monotherapy or combination therapy with either oral venetoclax 400-800 mg daily (eftozanermin alfa 1.25-7.5 mg/kg Days 1/8/15 of a 21-day cycle) or chemotherapy (eftozanermin alfa 3.75 or 7.5 mg/kg Days 1/8/15/22 of a 28-day cycle and FOLFIRI regimen [leucovorin, 5-fluorouracil, and irinotecan] with/without bevacizumab on Days 1/15 of a 28-day cycle).

resultsSystemic exposures (maximum observed concentration [C

conclusionsThe study results, including a pharmacokinetic profile consistent with weekly dosing and low incidence of immunogenicity, support further investigation of eftozanermin alfa. TRIAL REGISTRATION ID: NCT03082209.

Indexed as

Antineoplastic AgentsBridged Bicyclo Compounds, HeterocyclicHematologic NeoplasmsNeoplasmsAdultHumansSulfonamidesAntineoplastic AgentsBridged Bicyclo Compounds, HeterocyclicSulfonamidesvenetoclaxEftozanermin alfaImmunogenicityPharmacokineticsTumor necrosis factor-related apoptosis-inducing ligand (TRAIL)

Identifiers

PMID38036720
OpenAlexW4389162574

What OpenQuestion holds

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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.