Daiichi Sankyo Externally
Sponsored Research

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Qualified external investigators are requested to read about areas of interest related to our products

For Letter of Support Requests: For information regarding the submission process, please contact your country Medical Science Liaison. If you need further clarification, please reach out to OncologyESR@daiichisankyo.com.

For interest in Daiichi Sankyo compounds other than those listed below, please send an email to OncologyESR@daiichisankyo.com for oncology products or
Non-OncologyESR@daiichisankyo.com for all other products.

Oncology

Thank you for your interest. The submission period for this program is currently closed. Please continue to check back for updates regarding our next open submission window.

Thank you for your interest. The submission period for this program is currently closed. Please continue to check back for updates regarding our next open submission window.

Please Note: At this time only Collaborative Externally Sponsored Research proposals will be considered for Dato-DXd (except Japan-only studies) 

Non Small Cell Lung Cancer

  • Efficacy/safety in patient populations not reflected or under-represented in Phase 3 trials (including RWE) [Dato-DXd - Lung: 0106]
  • Dato-DXd Combinations that do not overlap with the ongoing clinical program where clear rationale exists [Dato-DXd - Lung: 0107]
  • Explore biomarkers that may inform treatment response or resistance to Dato DXd [Dato-DXd - Lung: 0108]
  • Identifying mechanisms, risk/predictive factors and optimal management of key AESIs (e.g. stomatitis, ocular surface events, ILD) [Dato-DXd - Lung: 0109]

Breast Cancer

  • Identifying risk factors, underlying mechanisms, predictive biomarkers and optimal management of adverse events associated with Dato-DXd (in particular AESIs such as stomatitis & ocular surface events) to support adherence* [Dato-DXd - Breast: 0085]
  • Evaluating Dato-DXd in lower-risk eTNBC patient populations including stage I patients and adjuvant treatment for patients without residual disease or those who received no prior neoadjuvant therapy [Dato-DXd - Breast: 0086]
  • Combination of Dato-DXd with novel agents supported by strong rationale/data (excluding conventional chemotherapy combinations) [Dato-DXd - Breast: 0087]
  • Exploring biomarkers and association with clinical outcomes and/or mechanisms of resistance* [Dato-DXd - Breast: 0088]
  • Efficacy and safety in patient population not represented/underrepresented in registrational studies (inclusive of real-world or clinical studies). For example: IO-pretreated in eBC, Dato-DXd reintroduction in mTNBC among patients who were treated with Dato-DXd in an early TNBC setting, etc [Dato-DXd - Breast: 0089]

Other Cancers

  • Evaluation of Dato-DXd in tumor types with high unmet need, good mechanistic rationale for use, and limited treatment options. Proposals will be prioritized in regions where results may inform clinical practice [Dato-DXd - Other: 0095]

* Multiple projects already ongoing, new proposals can be considered if not overlapping with existing portfolio

To apply, click here to return to the homepage where you will find detailed instructions on the "How to Apply" tab.

Please make note of the code related to the AOI you will be submitting against – you will need this during the application process.

Note: if a proposal does not fit a listed AOI, please select the one that you consider most relevant. Proposals that align to posted AOIs will be prioritized, but proposals that do not fit the AOIs will still be evaluated based on scientific rigor and strategic interest.

Please Note: At this time only Collaborative Externally Sponsored Research proposals will be considered for T-DXd (except Japan-only studies)

HER2+ Breast Cancer

  • Optimal treatment approaches to maximize patient experience and outcomes with T-DXd in 1L mBC and eBC [T-DXd - Breast: 0123]
  • Exploration of benefit of T-DXd in broadening the patient population in eBC [T-DXd - Breast: 0124]
  • Combination treatment strategies with novel modalities [T-DXd - Breast: 0125]
  • Evaluate peri-operative strategies with T-DXd in eBC [T-DXd - Breast: 0126]

HER2low Breast Cancer

  • Exploration of benefit of T-DXd in subpopulations with high unmet need [T-DXd - Breast: 0127]
  • Clinical applicability of technologies (AI / Digital / Computational path) to approach patient ID, spanning the HER2 spectrum [T-DXd - Breast: 0132]
  • Explore approaches to maximize patient response [T-DXd - Breast: 0133]

Breast Indication Non-specific

  • Novel combinations, translational or clinical approaches to delay resistance and optimize outcomes [T-DXd - Breast: 0128]
  • Characterizing treatment patterns and benefit risk profile in BC using large scale RWE [T-DXd - Breast: 0129]
  • Identify population at risk for high-grade AEs and strategies for prophylaxis & management and optimize patient's experience [T-DXd - Breast: 0130]
  • Rechallenge strategies with T-DXd within different LoT [T-DXd - Breast: 0131]

HER2-expressing Gastric Cancer

  • In early disease: Unmet need, outcomes by geographic location, and HER2 expression
    In advanced disease: Real-world outcomes, treatment patterns and sequencing such as following immuno-oncology and/or other regimens [T-DXd - GI: 0146]
  • Clinical activity and safety in HER2-expressing disease, including combinations with T-DXd [T-DXd - GI: 0147]
  • HER2 dynamics and prevalence over time in response to different treatment combinations/monotherapy (including overlapping biomarkers) [T-DXd - GI: 0153]

HER2-actionable Non-Small Cell Lung Cancer (NSCLC)

  • T-DXd efficacy and safety in 2L+ HER2 IHC 2+ NSCLC [T-DXd - Lung: 0167]
  • T-DXd as the backbone for novel combinations in HER2-altered 1L, exploring T-DXd safety and dosing [T-DXd - Lung: 0168]
  • T-DXd central nervous system brain metastasis efficacy in HER2 (overexpression, mutant) NSCLC [T-DXd - Lung: 0169]
  • Temporal changes in HER2 expression, through paired biopsies, across lines of treatment [T-DXd - Lung: 0170]

HER2-expressing Tumor Agnostic

  • Real-world T-DXd efficacy / safety, patient characteristics and biomarker expression in HER2-expressing malignancies with limited data or sub-populations of interest [T-DXd - Tumor Agnostic: 0139]
  • Novel technologies and methods to support patient identification [T-DXd - Tumor Agnostic: 0140]
  • Companion diagnostics utilization and real-world testing patterns [T-DXd - Tumor Agnostic: 0141]
  • Treatment patterns and impact of sequencing of novel treatments on T-DXd efficacy, safety and biomarker expression [T-DXd - Tumor Agnostic: 0142]

HER2-expressing Gynecological Tumors

  • Efficacy/safety of T-DXd-based regimens in lower IHC expression levels and rare gynecologic cancer histologies [T-DXd - GYN: 0155]
  • HER2 overlap with other biomarkers in gynecologic cancers [T-DXd - GYN: 0156]
  • Real-world outcomes of HER2-expressing patient populations in high-risk adjuvant endometrial cancer [T-DXd - GYN: 0158]
  • Real-world treatment patterns and outcomes of HER2+ patients in 1L ovarian cancer and relevant stratification with other subpopulations (e.g., BRCA, HRD, HER2 and PARPi/bevacizumab use) [T-DXd - GYN: 0154]

To apply, click here to return to the homepage where you will find detailed instructions on the "How to Apply" tab.

Please make note of the code related to the AOI you will be submitting against – you will need this during the application process.

Note: if a proposal does not fit a listed AOI, please select the one that you consider most relevant. Proposals that align to posted AOIs will be prioritized, but proposals that do not fit the AOIs will still be evaluated based on scientific rigor and strategic interest.

Please Note: Currently, we are only accepting Valemetostat proposals from the Japan region.
(Preclinical and Translational concepts only)

  • Mechanistic investigations into role of Enhancer of Zeste Homolog 1 (EZH1) and/or Enhancer of Zeste Homolog 2 (EZH2) activities on target expressions and signal transduction in prostate cancer, NSCLC, GC and BC. [Valemetostat : 0077]
  • Mechanistic investigations into the role of EZH1 and/or EZH2 on the tumor immune microenvironment (including the effect of valemetostat on graft vs host disease (GVHD) and graft vs leukemia (GVL)). [Valemetostat : 0100]
  • Mechanistic investigations characterizing/differentiating the role of EZH1 with dual inhibition vs EZH2 inhibition. [Valemetostat : 0099]
  • Mechanistic investigations for potential synergy with other Daiichi Sankyo medicines/pipeline candidates, other investigational or approved agents. [Valemetostat : 0098]
  • Investigation into novel predictive/prognostic biomarkers for valemetostat that may inform or refine patient selection and/or predict response/resistance for DXd combinations in BC, GC and NSCLC and IO combinations in NSCLC. [Valemetostat : 0097]
  • Mechanistic investigation as to the biological cause of common adverse events (i.e. thrombocytopenia, dysgeusia). [Valemetostat : 0096]

To apply, click here to return to the homepage where you will find detailed instructions on the "How to Apply" tab.

Please make note of the code related to the AOI you will be submitting against – you will need this during the application process.

Note: if a proposal does not fit a listed AOI, please select the one that you consider most relevant. Proposals that align to posted AOIs will be prioritized, but proposals that do not fit the AOIs will still be evaluated based on scientific rigor and strategic interest.

  • Exploring pexidartinib in select sarcomas, based on M1/ M2 subtypes (preclinical, translational, clinical). Non-registrational in nature. US region, Drug only. [Pexidartinib : 0076]

To apply, click here to return to the homepage where you will find detailed instructions on the "How to Apply" tab.

Please make note of the code related to the AOI you will be submitting against – you will need this during the application process.

Note: if a proposal does not fit a listed AOI, please select the one that you consider most relevant. Proposals that align to posted AOIs will be prioritized, but proposals that do not fit the AOIs will still be evaluated based on scientific rigor and strategic interest.

  • Quizartinib + Chemotherapy/Novel Backbones (Beyond 7+3 and Ven/Aza) in Newly Diagnosed FLT3-ITD(+) and FLT3-ITD(-) AML [Quizartinib : 0073]
  • Quizartinib Post-Remission in FLT3-ITD(+) and FLT3-ITD(-) AML (Monotherapy, Combination, Sequential) [Quizartinib : 0074]
  • New Combinations in FLT3-ITD(+) and FLT3-ITD(-) Relapsed/Refractory AML Patients with NPM1m [Quizartinib : 0075]

To apply, click here to return to the homepage where you will find detailed instructions on the "How to Apply" tab.

Please make note of the code related to the AOI you will be submitting against – you will need this during the application process.

Note: if a proposal does not fit a listed AOI, please select the one that you consider most relevant. Proposals that align to posted AOIs will be prioritized, but proposals that do not fit the AOIs will still be evaluated based on scientific rigor and strategic interest.

Thank you for your interest. The submission period for this program is currently closed. Please continue to check back for updates regarding our next open submission window.


Non-Oncology

  • All strokes
  • Aortic Valve Disease
  • Cardiomyopathy
  • Cardioversion
  • Congestive heart failure
  • Clinically Relevant Non-Major Bleeding (CRNMB)
  • Coronary Artery Disease (CAD)
  • Deep Vein Thrombosis (DVT)
  • Diabetes
  • (Post) Intracerebral hemorrhage in AF patients
  • (Post) Intracranial hemorrhage in AF patients
  • Bleeding, major
  • Bleeding, any
  • Mortality, all cause
  • Mortality, cardiovascular
  • Myocardial infarction
  • Percutaneous Coronary Intervention
  • Peripheral Arterial Disease (PAD)
  • Thromboprophylaxis
  • Valvular thrombosis
  • Vascular calcification
  • Venous Thromboembolism (VTE)
  • Stroke, all
  • Stroke, hemorrhagic
  • Stroke, ischemic
  • Quality of life
  • Adherence
  • Treatment acceptance
  • Biomarkers
  • Predictive values
  • Efficacy
  • Safety
  • TAVI
  • TAVR
  • SAVR
  • Thrombosis
  • Treatment interruption

To apply, click here to return to the homepage where you will find detailed instructions on the "How to Apply" tab.

ONLY PROPOSALS FROM COUNTRIES IN EUROPE, ASIA (EXCLUDING CHINA), SOUTH and CENTRAL AMERICA MAY BE SUBMITTED THROUGH THE PORTAL. AT THIS TIME, PROPOSALS FROM ANY COUNTRIES OTHER THAN THOSE NOTED ABOVE CANNOT BE ACCEPTED THROUGH THIS PORTAL. PLEASE SUBMIT PROPOSALS FROM THE US, JAPAN, or CHINA THROUGH Non-OncologyESR@daiichisankyo.com.

  • Hypercholesterolemia
  • Atherosclerotic cardiovascular disease
  • Diabetes
  • Inflammation

To apply, click here to return to the homepage where you will find detailed instructions on the "How to Apply" tab.

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PP-US-MONC-0579-1  

07/2026