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Article ; Online: [No title information]

Agner, Bue Ross / Riley, Caroline Hasselbalch / Petersen, Søren Lykke / Spanggaard, Iben / Hutchings, Martin / Rohrberg, Kristoffer Staal / Højgaard, Martin

Ugeskrift for laeger

2024 Volume 186, Issue 9

Abstract: T-cell-based immunotherapy has recently evolved as a treatment option for a number of haematological malignancies and is also being developed in solid tumours. A common side effect of chimeric antigen T-cell therapy (CAR-T) and treatment with T-cell ... ...

Title translation	Cytokine release syndrome caused by antineoplastic treatment with CAR-T and T-cell engaging therapies.
Abstract	T-cell-based immunotherapy has recently evolved as a treatment option for a number of haematological malignancies and is also being developed in solid tumours. A common side effect of chimeric antigen T-cell therapy (CAR-T) and treatment with T-cell engagers is cytokine release syndrome (CRS), which is a potentially life-threatening condition characterized by release of inflammatory mediators. The treatment of CRS is similar to that of other hyper-inflammatory conditions and involves supportive treatment as well as immunosuppressive therapy. The risk of CRS can be mitigated by step-up dosing and immunosuppressive pre-treatment, as argued in this review.
MeSH term(s)	Humans ; Receptors, Chimeric Antigen ; Cytokine Release Syndrome ; Antineoplastic Agents ; Immunotherapy ; Immunosuppressive Agents/adverse effects
Chemical Substances	Receptors, Chimeric Antigen ; Antineoplastic Agents ; Immunosuppressive Agents
Language	Danish
Publishing date	2024-02-26
Publishing country	Denmark
Document type	Review ; English Abstract ; Journal Article
ZDB-ID	124102-3
ISSN	1603-6824 ; 0041-5782
ISSN (online)	1603-6824
ISSN	0041-5782
DOI	10.61409/V08230544
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Article ; Online: Antiangiogenic Metargidin Peptide (AMEP) Gene Therapy in Disseminated Melanoma.

Spanggaard, Iben / Gehl, Julie

Methods in molecular biology (Clifton, N.J.)

2015 Volume 1317, Page(s) 359–364

Abstract: Gene delivery by electroporation is an efficient method for transfecting genes into various tissues including tumors. Here we present the treatment protocol used in a phase 1 study on gene electrotransfer of plasmid DNA encoding an antiangiogenic peptide ...

Abstract	Gene delivery by electroporation is an efficient method for transfecting genes into various tissues including tumors. Here we present the treatment protocol used in a phase 1 study on gene electrotransfer of plasmid DNA encoding an antiangiogenic peptide into cutaneous melanoma.
MeSH term(s)	ADAM Proteins/genetics ; ADAM Proteins/therapeutic use ; Angiogenesis Inhibitors/genetics ; Angiogenesis Inhibitors/therapeutic use ; Genetic Therapy/methods ; Humans ; Melanoma/therapy ; Membrane Proteins/genetics ; Membrane Proteins/therapeutic use ; Skin Neoplasms ; Melanoma, Cutaneous Malignant
Chemical Substances	Angiogenesis Inhibitors ; Membrane Proteins ; ADAM Proteins (EC 3.4.24.-) ; ADAM15 protein, human (EC 3.4.24.-)
Language	English
Publishing date	2015-06-10
Publishing country	United States
Document type	Clinical Trial, Phase I ; Journal Article
ISSN	1940-6029
ISSN (online)	1940-6029
DOI	10.1007/978-1-4939-2727-2_20
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Article ; Online: Precision patients: Selection practices and moral pathfinding in experimental oncology.

Dam, Mie S / Green, Sara / Bogicevic, Ivana / Hillersdal, Line / Spanggaard, Iben / Rohrberg, Kristoffer S / Svendsen, Mette N

Sociology of health & illness

2022 Volume 44, Issue 2, Page(s) 345–359

Abstract: This paper addresses selection practices in a Danish phase 1 unit specialised in precision medicine in the field of oncology. Where precision medicine holds the ambition of selecting genetically fit medicine for the patient, we find that precision ... ...

Abstract	This paper addresses selection practices in a Danish phase 1 unit specialised in precision medicine in the field of oncology. Where precision medicine holds the ambition of selecting genetically fit medicine for the patient, we find that precision medicine in the early trial setting is oriented towards selecting clinically and genetically fit patients for available treatment protocols. Investigating how phase 1 oncologists experience and respond to the moral challenges of selecting patients for early clinical trials, we show that inclusion criteria and patient categories are not always transparent to patients. Lack of transparency about inclusion criteria has been interpreted as morally problematic. Yet drawing on social science studies of 'unknowing', we argue that silence and non-transparency in interactions between oncologists and patients are crucial to respect the moral agency of patients at the edge of life and recognise them as belonging to the public of Danish health care. In the discussion, we consider the practice of placing 'unfit' patients on a waiting list for trial participation. Rather than representing an ethical and political problem, we argue, the waiting list can act as a valve enabling oncologists to navigate the scientific and as well as the moral uncertainties in phase 1 oncology.
MeSH term(s)	Humans ; Medical Oncology/methods ; Morals ; Precision Medicine/methods
Language	English
Publishing date	2022-01-07
Publishing country	England
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	795552-2
ISSN	1467-9566 ; 0141-9889
ISSN (online)	1467-9566
ISSN	0141-9889
DOI	10.1111/1467-9566.13424
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Article ; Online: [Trends in oncological phase I trials].

Rohrberg, Kristoffer Staal / Qvortrup, Camilla / Højgaard, Martin / Spanggaard, Iben

Ugeskrift for laeger

2019 Volume 181, Issue 20A

Abstract: This review summarises the current knowledge of anticancer therapy. More than 1,100 cancer drugs are currently under development in the United States. The increasing biological insight and platforms for high throughput screening of drugs have changed the ...

Abstract	This review summarises the current knowledge of anticancer therapy. More than 1,100 cancer drugs are currently under development in the United States. The increasing biological insight and platforms for high throughput screening of drugs have changed the developmental landscape of anticancer therapies from classical cytotoxic agents to targeted agents and immunotherapy. There is an increasing number of targeted agents, which are only efficacious in tumours harbouring specific genomic alterations in early clinical development. Furthermore, the landscape of immunotherapy broadens, and personalised immunotherapy is in development. The integration of genomic testing into early clinical oncology trials is increasing.
MeSH term(s)	Antineoplastic Agents ; Clinical Trials, Phase I as Topic ; Humans ; Immunologic Factors ; Immunotherapy ; Medical Oncology ; Neoplasms/drug therapy ; United States
Chemical Substances	Antineoplastic Agents ; Immunologic Factors
Language	Danish
Publishing date	2019-10-15
Publishing country	Denmark
Document type	Journal Article ; Review
ZDB-ID	124102-3
ISSN	1603-6824 ; 0041-5782
ISSN (online)	1603-6824
ISSN	0041-5782
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Article ; Online: New pathogenic germline variants identified in mesothelioma.

Belcaid, Laila / Bertelsen, Birgitte / Wadt, Karin / Tuxen, Ida / Spanggaard, Iben / Højgaard, Martin / Benn Sørensen, Jens / Ravn, Jesper / Lassen, Ulrik / Cilius Nielsen, Finn / Rohrberg, Kristoffer / Westmose Yde, Christina

Lung cancer (Amsterdam, Netherlands)

2023 Volume 179, Page(s) 107172

Abstract: Background: Mesothelioma (MM) is associated with asbestos exposure, tumor heterogeneity and aggressive clinical behavior. Identification of germline pathogenic variants (PVs) in mesothelioma is relevant for identifying potential actionable targets and ... ...

Abstract	Background: Mesothelioma (MM) is associated with asbestos exposure, tumor heterogeneity and aggressive clinical behavior. Identification of germline pathogenic variants (PVs) in mesothelioma is relevant for identifying potential actionable targets and genetic counseling. Methods: 44 patients underwent whole exome sequencing (WES) or whole genome sequencing (WGS). Germline variants were selected according to association with inherited cancer using a 168-gene in silico panel, and variants classified according to ACMG/AMP classification as pathogenic (class 5) or likely pathogenic (class 4). Results: In total, 16 patients (36%) were found to carry pathogenic or likely pathogenic variants in 13 cancer associated genes (ATM, BAP1, BRCA2, CDKN2A, FANCA, FANCC, FANCD2, FANCM, MUTYH, NBN, RAD51B, SDHA and XPC). The germline PVs occurred in DNA repair pathways, including homologous recombination repair (HRR) (75%), nucleotide excision repair (6%), cell cycle regulatory (7%), base excision repair (6%), and hypoxic pathway (6%). Five (31%) patients with a germline PV had a first or second degree relative with mesothelioma compared to none for patients without a germline PV. Previously undiagnosed BRCA2 germline PVs were identified in two patients. Potential actionable targets based on the germline PVs were found in four patients (9%). Conclusion: This study revealed a high frequency of germline PVs in patients with mesothelioma. Furthermore, we identified germline PVs in two genes (NBN & RAD51B) not previously associated with mesothelioma. The data support germline testing in mesothelioma and provide a rationale for additional investigation of the HRR pathway as a potential actionable target.
MeSH term(s)	Humans ; Genetic Predisposition to Disease ; Lung Neoplasms/genetics ; Mesothelioma/genetics ; Mesothelioma, Malignant ; Germ-Line Mutation ; Germ Cells ; DNA Helicases/genetics
Chemical Substances	FANCM protein, human (EC 3.6.1.-) ; DNA Helicases (EC 3.6.4.-)
Language	English
Publishing date	2023-03-15
Publishing country	Ireland
Document type	Journal Article ; Review
ZDB-ID	632771-0
ISSN	1872-8332 ; 0169-5002
ISSN (online)	1872-8332
ISSN	0169-5002
DOI	10.1016/j.lungcan.2023.03.008
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Article: Immune Cell Profiling of Peripheral Blood as Signature for Response During Checkpoint Inhibition Across Cancer Types.

Araujo B de Lima, Vinicius / Hansen, Morten / Spanggaard, Iben / Rohrberg, Kristoffer / Reker Hadrup, Sine / Lassen, Ulrik / Svane, Inge Marie

Frontiers in oncology

2021 Volume 11, Page(s) 558248

Abstract: Despite encouraging results with immune checkpoint inhibition (ICI), a large fraction of cancer patients still does not achieve clinical benefit. Finding predictive markers in the complexity of the tumor microenvironment is a challenging task and often ... ...

Abstract	Despite encouraging results with immune checkpoint inhibition (ICI), a large fraction of cancer patients still does not achieve clinical benefit. Finding predictive markers in the complexity of the tumor microenvironment is a challenging task and often requires invasive procedures. In our study, we looked for putative variables related to treatment benefit among immune cells in peripheral blood across different tumor types treated with ICIs. For that, we included 33 patients with different solid tumors referred to our clinical unit for ICI. Peripheral blood mononuclear cells were isolated at baseline, 6 and 20 weeks after treatment start. Characterization of immune cells was carried out by multi-color flow cytometry. Response to treatment was assessed radiologically by RECIST 1.1. Clinical outcome correlated with a shift towards an effector-like T cell phenotype, PD-1 expression by CD8+T cells, low levels of myeloid-derived suppressor cells and classical monocytes. Dendritic cells seemed also to play a role in terms of survival. From these findings, we hypothesized that patients responding to ICI had already at baseline an immune profile, here called 'favorable immune periphery', providing a higher chance of benefitting from ICI. We elaborated an index comprising cell types mentioned above. This signature correlated positively with the likelihood of benefiting from the treatment and ultimately with longer survival. Our study illustrates that patients responding to ICI seem to have a pre-existing immune profile in peripheral blood that favors good outcome. Exploring this signature can help to identify patients likely to achieve benefit from ICI.
Language	English
Publishing date	2021-03-25
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2649216-7
ISSN	2234-943X
ISSN	2234-943X
DOI	10.3389/fonc.2021.558248
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Article ; Online: Targeting HER2-mutant metastatic cervical cancer with neratinib: Final results from the phase 2 SUMMIT basket trial.

Friedman, Claire F / D'Souza, Anishka / Bello Roufai, Diana / Tinker, Anna V / de Miguel, Maria / Gambardella, Valentina / Goldman, Jonathan / Loi, Sherene / Melisko, Michelle E / Oaknin, Ana / Spanggaard, Iben / Shapiro, Geoffrey I / ElNaggar, Adam C / Panni, Stefano / Ravichandran, Vignesh / Frazier, Aimee L / DiPrimeo, Daniel / Eli, Lisa D / Solit, David B

Gynecologic oncology

2024 Volume 181, Page(s) 162–169

Abstract: Objective: HER2 mutations are associated with poor prognosis and are detected in 3-6% of cervical cancers. Neratinib, an irreversible pan-HER tyrosine kinase inhibitor, had activity in several HER2-mutant cancer types in the phase 2 SUMMIT basket study. ...

Abstract	Objective: HER2 mutations are associated with poor prognosis and are detected in 3-6% of cervical cancers. Neratinib, an irreversible pan-HER tyrosine kinase inhibitor, had activity in several HER2-mutant cancer types in the phase 2 SUMMIT basket study. We present updated and final results from the cervical cancer cohort of SUMMIT. Methods: Eligible patients had HER2-mutant, metastatic or recurrent cervical cancer progressing after platinum-based treatment for advanced/recurrent disease. Patients received neratinib 240 mg/day; loperamide was mandatory during cycle 1. Confirmed objective response rate (ORR) was the primary endpoint. Duration of response (DoR), clinical benefit rate (CBR), progression-free survival (PFS), and safety were secondary endpoints. Results: Twenty-two patients were enrolled; 18 (81.8%) had endocervical adenocarcinoma; median two prior systemic chemotherapy regimens (range 1-4). The most common HER2 variant was S310F/Y mutation (n = 13; 59.1%). Four patients had confirmed partial responses (ORR 18.2%; 95% CI 5.2-40.3); 6 had stable disease ≥16 weeks (CBR 45.5%; 95% CI 24.4-67.8). Median DoR was 7.6 months (95% CI 5.6-12.3). Median PFS was 5.1 months (95% CI 1.7-7.2). All-grade diarrhea (90.9%), nausea (54.5%), and constipation (54.5%) were the most common adverse events. Five patients (22.7%) reported grade 3 diarrhea. There were no grade 4 adverse events, no diarrhea-related treatment discontinuations, and two grade 5 adverse events, unrelated to neratinib: dyspnea (n = 1) and embolism (n = 1). Conclusions: Neratinib resulted in durable responses and disease control in patients with HER2-mutant metastatic/recurrent cervical cancer in SUMMIT. These findings support next-generation sequencing and tailored therapy for select patients with advanced cervical cancer. All responses occurred in patients with endocervical adenocarcinoma. Further assessment of neratinib in this setting is warranted. Trial registration number: NCT01953926 (ClinicalTrials.gov), 2013-002872-42 (EudraCT).
MeSH term(s)	Humans ; Female ; Receptor, ErbB-2/genetics ; Treatment Outcome ; Uterine Cervical Neoplasms/drug therapy ; Uterine Cervical Neoplasms/genetics ; Neoplasm Recurrence, Local/drug therapy ; Neoplasm Recurrence, Local/genetics ; Quinolines/adverse effects ; Diarrhea/chemically induced ; Antineoplastic Combined Chemotherapy Protocols/adverse effects ; Adenocarcinoma/drug therapy
Chemical Substances	Receptor, ErbB-2 (EC 2.7.10.1) ; neratinib (JJH94R3PWB) ; Quinolines
Language	English
Publishing date	2024-01-11
Publishing country	United States
Document type	Clinical Trial, Phase II ; Journal Article
ZDB-ID	801461-9
ISSN	1095-6859 ; 0090-8258
ISSN (online)	1095-6859
ISSN	0090-8258
DOI	10.1016/j.ygyno.2023.12.004
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Article ; Online: First-in-human phase 1 dose-escalation study of CAN04, a first-in-class interleukin-1 receptor accessory protein (IL1RAP) antibody in patients with solid tumours.

Robbrecht, Debbie / Jungels, Christiane / Sorensen, Morten Mau / Spanggaard, Iben / Eskens, Ferry / Fretland, Signe Ø / Guren, Tormod Kyrre / Aftimos, Philippe / Liberg, David / Svedman, Christer / Thorsson, Lars / Steeghs, Neeltje / Awada, Ahmad

British journal of cancer

2021 Volume 126, Issue 7, Page(s) 1010–1017

Abstract: Background: Interleukin-1 (IL-1) signalling is involved in various protumoural processes including proliferation, immune evasion, metastasis and chemoresistance. CAN04 is a first-in-class monoclonal antibody that binds IL-1 receptor accessory protein ( ... ...

Abstract	Background: Interleukin-1 (IL-1) signalling is involved in various protumoural processes including proliferation, immune evasion, metastasis and chemoresistance. CAN04 is a first-in-class monoclonal antibody that binds IL-1 receptor accessory protein (IL1RAP), required for IL-1 signalling. In this first-in-human phase 1 study, we assessed safety, recommended phase 2 dose (RP2D), pharmacokinetics, pharmacodynamics and preliminary anti-tumour activity of CAN04 monotherapy. Methods: Patients with advanced solid tumours known to express IL1RAP and refractory to standard treatments were enrolled in a dose-escalation study with 5 dose levels (1.0-10.0 mg/kg) of weekly CAN04. Results: Twenty-two patients were enrolled. Most common adverse events were infusion-related reactions (41%), fatigue (32%), constipation (27%), diarrhoea (27%), decreased appetite (23%), nausea (23%) and vomiting (23%). One dose limiting toxicity was reported. No maximum tolerated dose was identified. Pharmacokinetics analyses indicate higher exposures and slower elimination with increasing doses. Decreases in serum IL-6 and CRP were observed in most patients. Twenty-one patients were evaluable for response, 43% had stable disease per immune-related response criteria with no partial/complete responses. Conclusions: The IL1RAP targeting antibody CAN04 can be safely administered to patients up to 10.0 mg/kg weekly, which was defined as the RP2D. Serum biomarkers supported target engagement and IL-1 pathway inhibition. Clinical trial registration: NCT03267316.
MeSH term(s)	Antibodies, Monoclonal/adverse effects ; Antineoplastic Agents ; Dose-Response Relationship, Drug ; Humans ; Interleukin-1 Receptor Accessory Protein/therapeutic use ; Maximum Tolerated Dose ; Neoplasms/pathology
Chemical Substances	Antibodies, Monoclonal ; Antineoplastic Agents ; IL1RAP protein, human ; Interleukin-1 Receptor Accessory Protein
Language	English
Publishing date	2021-12-13
Publishing country	England
Document type	Clinical Trial, Phase I ; Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	80075-2
ISSN	1532-1827 ; 0007-0920
ISSN (online)	1532-1827
ISSN	0007-0920
DOI	10.1038/s41416-021-01657-7
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Article ; Online: ProTarget: a Danish Nationwide Clinical Trial on Targeted Cancer Treatment based on genomic profiling - a national, phase 2, prospective, multi-drug, non-randomized, open-label basket trial.

BMC cancer

2023 Volume 23, Issue 1, Page(s) 182

Abstract: Background: An increasing number of trials indicate that treatment outcomes in cancer patients with metastatic disease are improved when targeted treatments are matched with druggable genomic alterations in individual patients (pts). An estimated 30-80% ...

Abstract	Background: An increasing number of trials indicate that treatment outcomes in cancer patients with metastatic disease are improved when targeted treatments are matched with druggable genomic alterations in individual patients (pts). An estimated 30-80% of advanced solid tumors harbor actionable genomic alterations. However, the efficacy of personalized cancer treatment is still scarcely investigated in larger, controlled trials due to the low frequency and heterogenous distribution of druggable alterations among different histologic tumor types. Therefore, the overall effect of targeted cancer treatment on clinical outcomes still needs investigation. Study design/methods: ProTarget is a national, non-randomized, multi-drug, open-label, pan-cancer phase 2 trial aiming to investigate the anti-tumor activity and toxicity of currently 13 commercially available, EMA-approved targeted therapies outside the labeled indication for treatment of advanced malignant diseases, harboring specific actionable genomic alterations. The trial involves the Danish National Molecular Tumor Board for confirmation of drug-variant matches. Key inclusion criteria include a) measurable disease (RECIST v.1.1), b) ECOG performance status 0-2, and c) an actionable genomic alteration matching one of the study drugs. Key exclusion criteria include a) cancer type within the EMA-approved label of the selected drug, and b) genomic alterations known to confer drug resistance. Initial drug dose, schedule and dose modifications are according to the EMA-approved label. The primary endpoint is objective response or stable disease at 16 weeks. Pts are assigned to cohorts defined by the selected drug, genomic alteration, and tumor histology type. Cohorts are monitored according to a Simon's two-stage-based design. Response is assessed every 8 weeks for the first 24 weeks, then every 12 weeks. The trial is designed similar to the Dutch DRUP and the ASCO TAPUR trials and is a partner in the Nordic Precision Cancer Medicine Trial Network. In ProTarget, serial fresh tumor and liquid biopsies are mandatory and collected for extensive translational research including whole genome sequencing, array analysis, and RNA sequencing. Discussion: The ProTarget trial will identify new predictive biomarkers for targeted treatments and provide new data and essential insights in molecular pathways involved in e.g., resistance mechanisms and thereby potentially evolve and expand the personalized cancer treatment strategy. Protocol version: 16, 09-MAY-2022. Trial registration: ClinicalTrials.gov Identifier: NCT04341181. Secondary Identifying No: ML41742. EudraCT No: 2019-004771-40.
MeSH term(s)	Humans ; Denmark ; Genomics ; Neoplasms/pathology ; Prospective Studies ; Treatment Outcome
Language	English
Publishing date	2023-02-22
Publishing country	England
Document type	Clinical Trial, Phase II ; Journal Article
ZDB-ID	2041352-X
ISSN	1471-2407 ; 1471-2407
ISSN (online)	1471-2407
ISSN	1471-2407
DOI	10.1186/s12885-023-10632-9
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Article ; Online: A first-in-human study of the fibroblast activation protein-targeted, 4-1BB agonist RO7122290 in patients with advanced solid tumors.

Melero, Ignacio / Tanos, Tamara / Bustamante, Mariana / Sanmamed, Miguel F / Calvo, Emiliano / Moreno, Irene / Moreno, Victor / Hernandez, Tatiana / Martinez Garcia, Maria / Rodriguez-Vida, Alejo / Tabernero, Josep / Azaro, Analia / Ponz-Sarvisé, Mariano / Spanggaard, Iben / Rohrberg, Kristoffer / Guarin, Ernesto / Nüesch, Eveline / Davydov, Iakov I / Ooi, Chiahuey /

Duarte, José / Chesne, Evelyne / McIntyre, Christine / Ceppi, Maurizio / Cañamero, Marta / Krieter, Oliver

Science translational medicine

2023 Volume 15, Issue 695, Page(s) eabp9229

Abstract: This first-in-human study evaluated RO7122290, a bispecific fusion protein carrying a split trimeric 4-1BB (CD137) ligand and a fibroblast activation protein α (FAP) binding site that costimulates T cells for improved tumor cell killing in FAP-expressing ...

Abstract	This first-in-human study evaluated RO7122290, a bispecific fusion protein carrying a split trimeric 4-1BB (CD137) ligand and a fibroblast activation protein α (FAP) binding site that costimulates T cells for improved tumor cell killing in FAP-expressing tumors. Patients with advanced or metastatic solid tumors received escalating weekly intravenous doses of RO7122290 as a single agent (
MeSH term(s)	Humans ; CD8-Positive T-Lymphocytes/metabolism ; Neoplasms/pathology ; Fibroblasts/pathology
Language	English
Publishing date	2023-05-10
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2518854-9
ISSN	1946-6242 ; 1946-6234
ISSN (online)	1946-6242
ISSN	1946-6234
DOI	10.1126/scitranslmed.abp9229
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