The Cancer Molecular Screening and Therapeutics (MoST) Program - A framework protocol for multiple, parallel, signal-seeking clinical studies of novel molecularly targeted therapies for patients with advanced cancer and unmet clinical need.

Trial Summary:

The rapid advance in genomic technologies presents the unprecedented opportunity to molecularly phenotype cancers and link genetic information to therapeutic opportunities for individual patients. However, therapeutic translation of genomic opportunities has not paralleled the pace of scientific discovery, due to the decreased efficiency and increased costs of clinical research.

The fundamental premise of the Cancer Molecular Screening and Therapeutics (MoST) Program is that innovations in clinical trial design are needed to expedite translation of discovery into improved health outcomes. A novel modular signal-seeking trial design is proposed with a framework protocol that links a molecular screening platform to multiple clinical substudies for new treatments and/or indications. The framework includes a description of study processes, the organisation of the study and methodology to streamline the development and implementation of individual signal-seeking substudy modules, thereby allowing rapid assessment of new personalised treatments. As each substudy is developed it will be annotated to this framework protocol as an addendum which will be an inherent part of the framework protocol.

We anticipate that the findings of the MoST program will inform the more efficient and successful development of formal phase II testing of novel indications for therapy.

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In general, entry into the MoST program will be based on the following guiding principles;

a. Patients with pathologically confirmed, advanced or metastatic cancer (or patients with poor prognosis cancers) of any histologic type for whom a suitable biospecimen for molecular testing is available;

b. Priority will be given to patients without established therapeutic options, including existing clinical trials (i.e. unmet clinical need);

c. Patients should be suitable for therapeutic interventions (adequate performance status and organ function, capacity, availability and location, consent).

Patients who are screened through the screening platform will be considered eligible for each individual signal-seeking trial based on the specific eligibility criteria in the substudy addendum, including identification of a suitable actionable molecular and/or eligible clinical profile via the screening platform.

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David Thomas