Abstract CT128: A study evaluating targeted therapies in participants who have advanced solid tumors with genomic alterations or protein expression patterns predictive of response (MyTACTIC)
Authors: Spigel David R. , Whitehead Zachary , Kim Young , Szado Tania , McDonald Anne , Darbonne Walter C. , Levy Jonathan , Borden Eucharia , Mahadevan Daruka , VanderWalde Ari 
Published: June 2022

Abstract
Background: Cancer treatment is evolving toward a more personalized approach in which the intersection of genomics, pathology and imaging methods leads to individualized care. Furthermore, identification of novel genomic alterations and other biomarkers has the potential to lead to customized, targeted treatments. Matching specific therapies to tumor biomarkers has the potential to yield valuable clinical information. Here we present a multiarm basket trial that matches patients with a broad array of metastatic solid cancers to investigational therapies alone or in combination based on specific, targetable genomic alterations or protein expression patterns that are potentially predictive of response (MyTACTIC). Historically, such trials have been conducted at large academic medical centers rather than community centers, where most US patients with cancer receive treatment. Prioritizing community centers for this study presents an exciting opportunity to generate data from a more representative patient population.
Methods: MyTACTIC (NCT04632992) is a phase II, multicenter, nonrandomized, open-label study aiming to enroll approximately 260 participants with advanced solid tumors that harbor alterations including mutations, fusions, amplifications and protein loss in specific biomarkers that include ROS proto-oncogene 1 (ROS1), phosphatidylinositol-4,5-Bisphosphate 3-Kinase Catalytic Subunit Alpha (PIK3CA), anaplastic lymphoma kinase (ALK), protein kinase B (AKT), phosphatase and tensin homolog (PTEN), high tumor mutational burden (TMB), high microsatellite instability (MSI), deficient mismatch repair (dMMR), erb-b2 receptor tyrosine kinase 2 (ERBB2) and Ret proto-oncogene (RET). Patients aged ≥18 years with positive local biomarker results from tissue or blood samples will be enrolled from academic and community oncology centers and practices. Eligibility criteria have been broadened to allow enrollment of a diverse population of patients, including those with nonmeasurable disease, HIV or viral hepatitis infections, and to allow for previous treatment with anticancer agents in the same class. Once general and arm-specific criteria are met, patients will be assigned to 1 of 15 treatment arms to receive mono- or combination therapy with targeted agents, immunotherapy and/or chemotherapy (≤25 patients per arm). The primary objective is to evaluate confirmed objective response rate, as assessed by the investigator according to RECIST version 1.1 or RANO criteria for primary central nervous system tumors. Progression-free survival, duration of response, overall survival and safety will also be assessed. Special attention has been paid to the study design and implementation to ensure equitable access, along with flexibility to add additional baskets. Enrollment is ongoing.
Citation Format: David R. Spigel, Zachary Whitehead, Young Kim, Tania Szado, Anne McDonald, Walter C. Darbonne, Jonathan Levy, Eucharia Borden, Daruka Mahadevan, Ari VanderWalde. A study evaluating targeted therapies in participants who have advanced solid tumors with genomic alterations or protein expression patterns predictive of response (MyTACTIC) [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2022; 2022 Apr 8-13. Philadelphia (PA): AACR; Cancer Res 2022;82(12_Suppl):Abstract nr CT128.