Investigator Sponsored Research


Astellas and its alliance partners are committed to supporting investigator sponsored research studies that promote the advancement of medical and scientific knowledge and innovation involving Astellas products and therapeutic areas of interest.

What is Investigator Sponsored Research?
Investigator Sponsored Research (ISR) is proposed by a Sponsor-Investigator or institution for which support is requested to obtain an Astellas compound, and/or funding to perform specific research. The Investigator assumes full responsibilities for the research/study as the Sponsor.

Investigator Sponsored Research Overview:
Sponsor-Investigator or institution proposing the research can be an investigator, physician, non-clinical researcher, clinical research group, consortia and/or Cooperative Group. ISRs include, but are not limited to, non-clinical or clinical research, including epidemiological, non-interventional (e.g., registries) and interventional studies. Requests for support for a specific independent study with treatment and/or analysis according to a protocol must be classified as an ISR.

ISR proposals must be submitted independently (no influence by Astellas) through the ISR submission portal and reviewed by Astellas medical and scientific committees. The decisions of the committees are based upon scientific merit, alignment with research areas of interest, and availability of resources.

The areas of interest may provide Investigators with additional knowledge about open ISR programs to see whether their research proposal and expertise fits with recognized priorities. Astellas is interested in supporting studies that are innovative and contribute to scientific knowledge of a product, a disease state, medical condition or advancing technology. The areas of interest are to serve as a guidance for submission of a proposal and does not guarantee Astellas support.

Please refer to the table below for the areas of interest supported by Astellas.

Please click here to access the Astellas submission portal https://globalisrportal.force.com
 

CompoundArea of Interest and Areas of Non-Interest
enzalutamide
  • New Hormonal Therapy (NHT) rechallenge post NHT use in earlier stage of prostate cancer
  • Treatment intensification with new combinations utilizing NHT as backbone therapy
  • Adverse event management under standard enzalutamide dosing
  • Biomarkers to inform response, resistance and treatment decisions
  • Patient Reported Outcomes and Quality of Life in prostate cancer
  • New screening, artificial intelligence (AI), & diagnosis technology in conjunction with prostate cancer treatment
  • Understanding mechanisms of androgen receptor inhibitor action and resistance
  • Treatment of oligometastatic disease

The following proposal types will not be considered at this time:
All tumor types other than prostate cancer, country-specific studies where there is no rationale for data generation in sub-populations, healthcare resource utilization (cost analysis), and unapproved enzalutamide dosing

enfortumab vedotin (EV)

Practice Informing:

  • Adverse Event prevention, treatment and mitigation
  • Optimizing treatment initiation and sequencing
  • Retreatment
    • In patients who previously responded to Enfortumab vedotin ((muscle invasive bladder cancer (MIBC), locally advanced/metastatic urothelial cancer (la/mUC))
    • Biology of retreatment (i.e. changes in Nectin-4expression)

Proof of Concept:

  • la/mUC
    • Combinations/ sequences with targeted therapies
  • MIBC
    • Bladder Sparing (EV alone or in combination with multimodal therapy)
  • Nectin-4* expressing tumors with scientific rationale/ unmet need
    • Of interest but not limited to: Gyn tumors, Thyroid, GI not included in EV-202 Trial**, others as appropriate***

Biomarkers:

  • Biology of Resistance: clinical resistance
  • Biology of Nectin-4: expression dynamics post EV treatment***
  • Health Economics Outcomes Research (HEOR):
    • Patterns and outcomes of cycling (reuse) of treatment in urothelial cancer (UC)
  • Innovative modeling methods to further validate impact of novel combination therapies in advanced UC and other solid tumors

The following proposal types will not be considered at this time:

  • Research for EV duplicative with: clinical development program including EV-202**, ongoing ISR program, or ongoing/planned HEOR studies
  • Evaluation of altered route, dose or schedule of EV
  • Combinations of EV with unapproved therapies^
  • Health Resource Utilization, economic models and outcomes with EV
  • Preclinical resistance with Enfortumab vedotin
  • PD markers/response predictors (i.e. correlation of Nectin-4 expression and response)

* All nectin-4 testing to be performed by Q2
** Any stage, all tumor associated subtypes and combination until tumor development plan is implemented. Tumors included in EV-202 Trial are: HR+/HER2- Breast Cancer, Triple Negative Breast Cancer (TNBC), Squamous Non-Small Cell Lung Cancer (SNSCLC), Non-Squamous Non-Small Cell Lung Cancer (NSNSCLC), Head and Neck Cancer and Gastric, Gastroesophageal Junction or Esophageal Cancer
*** For tumors without Nectin-4 expression data, evaluation of Nectin-4 should be done.
^ For evaluation by business development

fezolinetant
  • Combination treatment (drug-drug or drug-device combinations, Traditional Chinese Medicine (TCM), antidepressants, combination with vaginal oestrogen, Selective Estrogen Receptor Modulator (SERM), osteoporosis medication)
  • Vasomotor symptoms (VMS) in the perimenopause population
  • Night sweats
  • VMS associated sleep disturbance
  • Breast cancer treatment induced VMS in women
  • Prostate cancer treatment induced VMS in men
  • Quality of Life and other patient reported outcomes (e.g. mood, sexual wellbeing, cognition, work productivity)
  • Sub-populations (e.g. >60 years old, women with comorbidities)
  • Special populations and other conditions (e.g. VMS associated with Systemic Lupus Erythematosus (SLE) and Parkinson’s disease, hyper-androgenism Polycystic Ovary Syndrome (PCOS), endometriosis, uterine fibroids)
  • Weight regulation e.g. weight change and redistribution of body fat associated with menopause
  • Previous or current hormone therapy users dissatisfied with their treatment outcome
  • Appropriate and relevant basic science and pre-clinical studies
  • Digital therapeutics in VMS in association with fezolinetant

The following proposal types will not be considered at this time:

  • High dose fezolinetant
  • Drug-drug interactions
  • Head-to-head studies vs. hormonal treatment and Neurokinin 3 (NK3) antagonists
  • Special populations (precocious puberty and studies in children)
  • Toxicity studies in male animals
  • Toxicity studies in juvenile animals
gilteritinib
  • FLT3 mutation positive (FLT3 m+) malignancies, acute myeloid leukemia (AML) and other high risk myelodysplastic syndromes (HR-MDS)
  • Targeted drug combinations with gilteritinib in FLT3 m+ (AML),sequencing with FLT3 inhibitors
  • Maintenance therapy in FLT3 m+ AML
  • Minimal residual disease (MRD) and impact on treatment outcomes in gilteritinib treated AML patients, mechanisms of resistance and allelic ratio
  • Wild type FLT3 AML

The following proposal types will not be considered at this time:

  • Pediatric studies
  • Bridge to transplant
  • Combination with other FLT3 inhibitors and head-to-head studies with other FLT3 inhibitors
ipragliflozin
  • Clinical and mechanistic studies regarding the effects of sodium-glucose co-transporter 2 (SGLT-2) inhibition with ipragliflozin associated type 1 diabetes mellitus (T1DM).
  • Real World Evidence research Observational research regarding the effects of SGLT-2 inhibition on micro / macro vascular complications in patients with T2DM and T1DM (databases, registries, clinical outcomes, non-interventional and retrospective data analysis).

The following proposal types are not being considered at this time:
Safety studies of Ipragliflozin, comparator studies with other SGLT- 2 inhibitors

roxadustat
  • Clinical efficacy outcomes
  • Special populations:
    • patients with chronic kidney disease (CKD) anemia with a functioning renal transplant
    • HIV+ patients with anemia of CKD (South Africa)
  • Iron metabolism
  • Treatment patterns
  • Patient Reported Outcomes (PROs): adherence and persistence
  • Mechanistic and biomarker studies
  • Renal anemia/anemia of CKD epidemiology

The following proposal types are not being considered at this time:
Off-label use studies, studies with roxadustat with safety as the primary endpoint (due to required size and length of such study), CKD progression, and single-arm interventional studies

tacrolimus

ADVAGRAF: Real World Evidence research including:

  • Database, registries, networks of treatment pattern of long-term clinical outcomes in liver/kidney transplantation (non-interventional and retrospective data)
  • Conversion from Prograf to Advagraf, de novo use of Advagraf (e.g. dose, trough level, renal function)
  • Risk factors evaluation related to treatment outcomes, (e.g. intrapatient variability, adherence)
  • COVID-19 related

PROGRAF:

  • Epidemiological studies in those countries who have launched/pre-launch autoimmune disease indication
  • Efficacy and safety outcome of Prograf treatment on auto-immune (AI) patients

The following proposal types are not being considered at this time:
Very low dose tacrolimus regimens (e.g. <3ng/ml) due to concerns with immunological injury or in studies with switch to Advagraf when tacrolimus levels are already low (e.g. <5ng/mL), comparison studies between generics with Prograf or Advagraf in terms of purity, pharmacokinetic (PK) or bioequivalence (BE) analysis, comparison studies between Prograf and Advagraf.

zolbetuximab

Practice informing*

  • Chemotherapy regimens not evaluated in zolbetuximab gastric cancer (GC)/gastroesophageal junction cancer (GEJC) development studies
  • HER2-ve, CLDN 18.2+ LA unresectable mGC/GEJC patient sub-segments
  • Adverse event management (prevention and treatment)
  • Second line+ or treatment and continued treatment beyond progression in patients expressing CLDN 18.2

Proof of Concept*

  • First line HER2ve+, CLDN 18,2+ LA unresectable or mGC/GEJC patients
  • CLDN 18.2 co-expressing tumors for combination with respective targeted therapies for G/GEJ
  • CLDN 18.2 expressing tumors with unmet need and scientific rationale

Biomarkers*

  • Biology of Resistance pathway/overcoming resistance pathway
  • Biomarker co-expression and testing practices in GC/GEJC

The following proposal types will not be considered at this time:

  • Duplicative with zolbetuximab development program/ISRs**
  • Evaluation of altered route, does or administration methodology or schedule or any deviation from prescribing information
  • Combinations with investigational therapies
  • Low CLDN 18.2 expressing (<50% of tumor cells with moderate to strong membranous staining) G/GEJ and other tumors

 

* CLDN 18.2 testing in ISR studies is recommended to be conducted with the Ventana assay

**HER2-ve, CLDN 18.2+ve resectable GC/GEJC and CLDN18.2+ve pancreatic cancer out of scope due to ongoing development program


Please click here to access the Astellas submission portal https://globalisrportal.force.com/