Marengo Therapeutics Initiates Pivotal STARt-002 Trial
Marengo Therapeutics Initiates STARt-002 Clinical Trial
Marengo Therapeutics, Inc. is excited to announce the dosing of the first patient in the STARt-002 clinical trial. This Phase 1b/2 study aims to evaluate Invikafusp alfa, a novel dual T cell agonist, in combination with Gilead's Trodelvy, a TROP2-directed antibody-drug conjugate (ADC), for patients battling metastatic breast cancer.
Trial Overview and Objectives
The STARt-002 trial is designed to assess the effectiveness and safety of these innovative treatments against HR+/HER2- and triple-negative breast cancer (TNBC). The trial begins with a run-in phase, which will identify the optimal combined doses, ensuring patient safety and therapeutic efficacy. Following this phase, the study will expand to two cohorts targeting metastatic TNBC and hormone receptor-positive, HER2-negative metastatic breast cancer.
Key Patient Enrollment Details
Currently, the STARt-002 clinical trial is active at several leading cancer treatment centers, including Massachusetts General Hospital and the Sarah Cannon Research Institute. With the promise of additional sites joining in the near future, the study aims to recruit a substantial number of participants to thoroughly evaluate the combination therapy's potential.
Significance of the Combination Therapy
Combining ADCs with immunotherapies has shown exciting potential, as evidenced by recent studies, like the ASCENT-04 trial that successfully paired sacituzumab govitecan with pembrolizumab in treating metastatic TNBC. Steven Isakoff, M.D., Ph.D., a prominent oncologist, expressed optimism about the growing evidence supporting such combinations. He emphasized that Invikafusp alfa represents a promising avenue for enhancing treatment options for patients with these challenging breast cancer subtypes.
Encouraging Initial Findings
Initial research indicates that Invikafusp alfa demonstrates compelling activity as a standalone treatment, particularly in instances resistant to conventional therapies such as PD-1 inhibitors. The implications of coupling it with Trodelvy could forge a potent new pathway in the fight against breast cancer, enhancing therapeutic strategies in previously underserved patient populations.
About Marengo Therapeutics
Marengo Therapeutics is dedicated to pioneering new and effective ways to treat various cancers through its innovative pipeline of TCR-targeting antibodies. The company's technology is centered around producing personalized immunotherapeutics that engage the body’s immune response to combat both cancer and autoimmune illnesses. Their proprietary STAR™, TriSTAR™, and MSTAR™ platforms serve as the foundation for these advances.
Further Insight into Invikafusp Alfa
Invikafusp alfa, the first candidate from Marengo's STAR™ platform, is designed to stimulate a specific subtype of T cells associated with tumor response. Current studies are investigating the efficacy of this agent both as a standalone treatment and in combination therapies, hinting at its versatility and potential impact across various tumor types.
About the STAR™ Platform
Marengo's STAR™ platform represents an innovative approach to cancer treatment through multispecific antibody-fusion technology. By targeting T cell receptor V? regions, it activates T cells in a non-clonal manner, promoting a durable immune response against tumors.
Frequently Asked Questions
What is the STARt-002 trial about?
The STARt-002 trial investigates the safety and efficacy of Invikafusp alfa with Trodelvy in patients with metastatic breast cancer.
Who are the key investigators involved in this trial?
Notable cancer specialists, including Steven Isakoff from Massachusetts General Hospital, are integral to the research and evaluation process.
What types of breast cancer are being targeted in the study?
The trial focuses on HR+/HER2- and triple-negative breast cancer patients.
What can the combination of Invikafusp alfa and Trodelvy potentially offer?
This combination aims to introduce a new therapeutic option that may improve treatment outcomes in challenging breast cancer cases.
How is Marengo Therapeutics advancing its technology?
Marengo utilizes groundbreaking platforms like STAR™ to develop precision immunotherapies tailored to individual patient needs and tumor characteristics.
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