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Phase 1 clinical trial report and supplementary data detailing preclinical evaluation, patient demographics, pharmacokinetics, and safety outcomes of the INBRX-109 antibody in chondrosarcoma.
Year:
2023
Study Type:
Preclinical and Phase 1 Clinical Trial
Drug:
INBRX-109
Disease Focus:
Chondrosarcoma
Trial Identifier:
NCT03715933
Pharmacokinetic Data:
Included
Population Characteristics:
Adult patients, predominantly male and White
Endpoints:
Safety, pharmacokinetics, immunogenicity
Supplementary Data:
Tables S1-S3, Figures S1-S6
References:
1-11
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Year of publication:
2025
Receipt of originals:
10/27/2025
Acceptance for publication:
11/27/2025
DOI:
https://doi.org/10.56238/isevjhv4n6-002
Authors:
Fernanda Cristina Galerani Gualtieri Parpinelli; Augustin Malzac; Henrique Lucas Codognoto; Cristina Jardelino de Lima; Guilherme Banck; Diogo Melo Mendo
Type of document:
Narrative literature review
Field:
Oncology; Orthopedic Oncology
Subject:
Multidisciplinary management of osteosarcoma, chondrosarcoma, and Ewing sarcoma
Population focus:
Pediatric and young patients with primary malignant bone tumors
Study period covered:
2015–2025
Databases consulted:
PubMed; Scopus; Cochrane
Therapeutic approaches discussed:
Surgical resection (R0 margins); Neoadjuvant and adjuvant chemotherapy (MAP; VAC/IE); Radiotherapy; Proton therapy; Immune checkpoint inhibitors; CAR-T cell therapy
Molecular aspects:
EWS-FLI1 translocation; IDH1/IDH2 mutations; Circulating tumor DNA (ctDNA)
Imaging modalities:
MRI; CT; PET-CT
Keywords:
Osteosarcoma; Chondrosarcoma; Ewing Sarcoma; Targeted Therapy; EWS-FLI1; Biomarkers; Immunotherapy
Date:
April 22nd, 2025
Region / City:
Paris, France
Subject:
Immuno-oncology, Biotechnology
Document Type:
Press Release
Organization / Institution:
Egle Therapeutics
Author:
Egle Therapeutics
Target Audience:
Medical and scientific professionals in immuno-oncology and biotechnology
Period of Activity:
2025
Date of Approval:
April 22nd, 2025
Date of Changes:
N/A
Year:
2026
Region / City:
N/A
Topic:
Cancer research, Immunotherapy
Document Type:
Research article
Organization / Institution:
N/A
Author:
Walid S. Kamoun, Anne-Sophie Dugast, James J. Suchy, Stephanie Grabow, Ross B. Fulton, James F. Sampson, Lia Luus, Michael Santiago, Alexander Koshkaryev, Gang Sun, Vasileios Askoxylakis, Eric Tam, Zhaohua Richard Huang, Daryl C. Drummond, Andrew J. Sawyer
Target Audience:
Researchers, Oncology professionals
Period of Action:
N/A
Approval Date:
N/A
Modification Date:
N/A
Year:
2021
Region / City:
Slough, UK
Topic:
Immunology, Dermatology
Document Type:
Research Article
Organization / Institution:
UCB
Author:
Joseph Rastrick, Hannah Edwards, Alex S. Ferecskó, Gaëlle Le Friec, Avneet Manghera, Matthew Page, Stevan Shaw
Target Audience:
Researchers, Healthcare Professionals
Period of Validity:
Not specified
Date of Approval:
Not specified
Date of Changes:
Not specified
Context:
The document is a research article presenting findings on the roles of IL-17A and IL-17F in hidradenitis suppurativa (HS), based on human in vitro and clinical experiments.
Neuroscience Preclinical Imaging Laboratory (NPIL) Neuro-Imaging Pilot Grants 2023 GRANT APPLICATION
Year:
2023
Region / City:
Stanford
Theme:
Neuroscience, Neuroimaging
Document Type:
Grant Application
Institution / Organization:
Wu Tsai Neurosciences Institute
Author:
Jieun Kim, PhD
Target Audience:
Neuroscience researchers, Principal Investigators, Co-Principal Investigators
Period of Action:
March 31, 2023
Approval Date:
Pending
Date of Changes:
N/A
Abstract:
This document outlines the application process for the NPIL Neuro-Imaging Pilot Grants, detailing eligibility, funding conditions, and the research proposal format required for submission.
Year:
2023
Region / Institution:
Multiple international research centers including 4HF Biotec GmbH, Oncotest GmbH, Charles River Discovery Research Services Germany GmbH
Subject Area:
Oncology, Pharmacology, Molecular Biology
Document Type:
Supplementary Material / Research Data
Experimental Models:
Patient-derived xenografts (PDX), Cell line-derived xenografts (CDX), Cell lines, Mouse tumour models
Methods:
RNA expression analysis (TPM), Affymetrix GeneChip arrays, SNP6.0 arrays, Whole-exome sequencing, Mass cytometry, Radiomics-based CT scans
Drug:
Rogenolisib (IOA-244)
Patient Cohorts:
Solid tumour patients, mUM, mCM, NHL-FL, mesothelioma
Endpoints:
Burden of therapy, Treatment-emergent adverse events (TEAEs), CD63+ basophils, Tumour lesion changes, Cell-free DNA, Protein expression levels, Immunoglobulin levels
Analyses:
Kaplan–Meier survival analysis, ANOVA, Linear mixed effect models, Correlation analyses
Timepoints:
Baseline to Week 16, up to Cycle 5 for patient-reported outcomes
Genetic Data:
SNVs, insertions/deletions, TMB, selected gene variants
Year:
2026
Type of document:
Research article / Supplemental methods
Subject:
Oncology, antibody–drug conjugates
Authors:
Wan-Fen Li, Ming-Feng Chiang, Hao-Cheng Weng, Jhih-Jie Yang, Hsin-Shan Wu, Szu-Yu Wu, Yu-Jung Chen, Chi‐Huan Lu, Jyy-Shiuan Tu, Ren-Yu Hsu, Chi-Sheng Shia, Teng-Yi Huang, Ming-Tain Lai
Affiliation:
Various research institutions (detailed in original publication)
Experimental models:
Multiple human and murine cancer cell lines, PDX models
Key molecules studied:
OBI-992, exatecan, Dato-DXd
Assays performed:
Hydrophobic interaction chromatography, RPLC-UV, LC/MS/MS, flow cytometry, ELISA, ATP measurement, RNA-seq
Cell lines:
NCI-N87, BxPC3, HCC827, NCI-H1975, MDA-MB-231, Capan-1, ES-2/GFP, MC38, HCC827/ABCB1, HCC827/ABCG2, Caco-2
Key outcomes measured:
DAR distribution, IC50 values, TROP2 expression, immunogenic cell death markers, ABC transporter expression
Data sources:
Crown Bioscience, WuXi Biologics, Human Protein Atlas
Year:
2023
Region / City:
Europe (Spain, Portugal, Slovenia, United Kingdom, Australia)
Topic:
Drug-induced liver injury, preclinical assessment
Document Type:
Systematic review
Institution / Organization:
ProEuroDILI Network, multiple universities and research institutes
Authors:
Antonio Segovia-Zafra, Marina Villanueva-Paz, Ana Sofia Serras, Gonzalo Matilla-Cabello, Ana Bodoque-García, Daniel Di Zeo-Sánchez, Hao Niu, Ismael Álvarez-Álvarez, Laura Sanz-Villanueva, Sergej Godec, Irina Milisav, Pierre Bagnaninchi, Raúl Jesús Andrade, María Isabel Lucena, José Carlos Fernández-Checa, Francisco Javier Cubero, Joana Paiva Miranda, Leonard Nelson
Target Audience:
Researchers and clinicians in pharmacology and hepatology
Data Type:
In vitro human models, cellular and non-cellular models
Period Covered:
Preclinical studies up to 2023
Corresponding Authors:
María Isabel Lucena, José Carlos Fernández-Checa
Supplementary Material:
Human hepatocyte cultures, liver microsomes, liver vesicles, 2D and 3D model systems
Year:
2026
Region / City:
International
Theme:
Oncology, Targeted Therapy
Document Type:
Supplemental Figure Legends
Institution / Organization:
Clinical Research Team
Authors:
Not specified
Target Population:
Patients with MET-positive gastric, hepatocellular, renal, and non-small cell lung cancers
Study Period:
Preclinical and clinical exploratory analyses
Data Collection Date:
Not specified
Drug Dosage:
Emibetuzumab 20 mg/kg qw, DC101 20 mg/kg 2qw intraperitoneally
Endpoints:
Progression-free survival, tumor response, biomarker expression
Cancer Types:
Gastric cancer, hepatocellular carcinoma, renal cell carcinoma, non-small cell lung cancer
Methodology:
Preclinical xenograft models, biomarker stratification, exploratory cut-off analysis
Supplement Figures:
Figures 1–3
Year:
2026
Region / city:
South San Francisco, CA, USA; Munich, Germany
Subject:
Oncology, Cancer Research
Document type:
Research Paper
Organization:
Amgen Research
Author:
Petra Deegen, Oliver Thomas, Olivier Nolan-Stevaux, Shyun Li, Joachim Wahl, Pamela Bogner, Famke Aeffner, Matthias Friedrich, Michael Z. Liao, Katja Matthes, Doris Rau, Benno Rattel, Tobias Raum, Peter Kufer, Angela Coxon, Julie M. Bailis
Target audience:
Researchers, oncologists, biotechnologists
Period of validity:
Not specified
Approval date:
Not provided
Date of changes:
Not provided
Year:
2019
Region / City:
Belo Horizonte, Minas Gerais, Brazil
Topic:
Hepatic encephalopathy, liver disease, preclinical research
Document type:
Minireview
Institution:
Universidade Federal de Minas Gerais (UFMG)
Authors:
Luiza Cioglia Dias Lima, Aline Silva Miranda, Rodrigo Novaes Ferreira, Milene Alvarenga Rachid, Ana Cristina Simões e Silva
Target audience:
Researchers and clinicians in hepatology and neuroscience
Received:
August 29, 2018
Peer-review started:
August 29, 2018
First decision:
October 16, 2018
Revised:
November 19, 2018
Accepted:
January 28, 2019
Published online:
February 27, 2019
Open Access:
Yes, CC BY-NC 4.0
Manuscript source:
Invited manuscript
Corresponding author:
Ana Cristina Simões e Silva, MD, PhD