Real world use of Zanidatamab in HER2+ Gastroesophageal, Adeno-carninoma, Breast Cancer, solid tumors
Jazz only supports study proposals that have a legitimate scientific purpose and take into account the importance of the study objectives to medical science and patient care and the ability of the study sponsor to deliver a high-quality ethical study. Submission of a proposal does not imply or guarantee approval.
Zanidatamab
- Explore use of zanidatamab as monotherapy or in combinations in HER2-positive gastroesophageal adeno-carcinoma:
- Clinical activity and safety of zanidatamab in HER2-positive metastatic GEA (>1L), including novel combinations with zanidatamab
- Efficacy and safety in early HER2-positive GEA (peri-OP), including novel combinations with zanidatamab
- Identify patients at risk for adverse events and strategies to mitigate
- Understand MoA of resistance (primary and secondary) to zanidatamab and explore strategies to delay and prevent progression in HER2-positive GEA
- Understand the biology of HER2-positive GI cancers
- Understand the unmet needs of HER2-positive GI cancers
- Real-world treatment patterns and outcomes
- Explore use of zanidatamab as monotherapy or in combinations in HER2-positive breast cancers:
- Zanidatamab as treatment strategy and sequencing, incl. novel combinations, in patients progressing or discontinuing from prior antiHER2 therapy
- Concepts to optimize and improve patient outcomes through novel combinations and de-escalation, incl. the endocrine sensitive setting
- Zanidatamab in special populations (elderly, ECOG PS >2, patients ineligible/intolerant to T-DXd)
- Efficacy and safety of zanidatamab in combination with palliative radiation for brain or bone metastases
- Understand MoA of resistance (primary and secondary) to zanidatamab and explore strategies to delay and prevent progression
- Real-world evidence and outcomes, observational studies in HER2-positive mBC
- Explore use of zanidatamab as monotherapy or in combinations in HER2-positive solid tumors/tumor agnostic:
- Zanidatamab, incl. novel combinations e.g. in lung, CRC, endometrial, ovarian, bladder, or salivary gland
- Zanidatamab, incl. novel combinations in HER2-mutated tumors
- Pre-clinical studies and signal-seeking studies in HER2-positive solid tumors in underrepresented patient populations
- Exploration of predictors of response / resistance incl approaches to understand, delay or overcome resistance in HER2-positive tumors
- Retreatment/rechallenge/sequencing strategies in HER2-positive tumors
- Zanidatamab MoA and biomarkers, HER2-receptor heterogeneity and dynamics over time
- HER2 testing methods, incl. NGS/liquid biopsy, to identify patients to benefit from zanidatamab
Jazz has a two-stage review process: concept and protocol review. After you submit your concept proposal, our Review Committee will notify you of our decision. If your concept is preliminarily accepted, Jazz will invite you to submit a full protocol within 90 days of the notification.
Please be prepared to provide the following information at the time of your concept submission:
- Primary Investigator information and a current CV
- Study hypothesis, objectives, and endpoints
- Background & rationale
- Study design
- Subject population
- Statistical analysis plan
- Publication plan
- Preliminary budget (a detailed budget will be required at the protocol stage)
- Quantity of product requested (if applicable)
PIRA™ proposals are AI generated and are not reviewed or endorsed by the sponsoring company.