Marengo Begins STARt-002 Trial with Invikafusp Alfa and Trodelvy® in Metastatic Breast Cancer

9 May 2025
Marengo Therapeutics, Inc., a biotechnology company focused on innovative precision T cell activation therapies, has initiated dosing in its STARt-002 clinical study. Located in Cambridge, Massachusetts, Marengo is examining the safety and effectiveness of its leading T cell agonist, invikafusp alfa, in combination with Gilead's Trodelvy® (sacituzumab govitecan-hziy) for patients with metastatic breast cancer (mBC). This marks an important step for the company as it explores new treatment combinations aimed at improving outcomes for individuals with specific types of breast cancer.

The STARt-002 trial, which is officially known as NCT06827613, is structured into two phases: an initial run-in phase to identify the optimal dose combination of the drugs, followed by a dose expansion phase. This latter phase is divided into two groups focusing on patients with metastatic triple-negative breast cancer (mTNBC) and hormone receptor-positive, HER2-negative (HR+/HER2-) metastatic breast cancer. This approach is part of a broader trend in oncology research exploring the synergy between antibody-drug conjugates (ADCs) and immunotherapies.

Dr. Steven Isakoff, a noted Medical Oncologist and Director of Breast Cancer Clinical Research at Massachusetts General Hospital, expressed optimism about the potential of combining ADCs with immunotherapies based on promising results from other studies. He highlighted the innovative nature of invikafusp alfa, which acts as a dual T cell agonist, showing significant activity as a single agent in tumors resistant to PD-1 inhibitors. This makes the combination of invikafusp alfa with Trodelvy® an exciting prospect for expanding treatment options for patients with both major subtypes of breast cancer.

The clinical trial is currently recruiting patients at Massachusetts General Hospital, Sarah Cannon Research Institute, and Princess Margaret Cancer Centre. It is anticipated that additional sites will join soon, broadening the trial's reach and potential impact.

Dr. Kevin Chin, Chief Medical Officer of Marengo Therapeutics, commented on recent presentations at prominent scientific meetings, citing the promising monotherapy activity of invikafusp alfa in PD-1 resistant tumors. This data supports the belief that invikafusp alfa could become a leading immunotherapy platform, particularly when used alongside ADCs in tumors that are typically less responsive to immunotherapy, such as breast cancer.

Marengo Therapeutics, leveraging its proprietary platforms like STAR™, TriSTAR™, and MSTAR™, is at the forefront of developing precision immunotherapies that harness the body's T cell repertoire. Their approach aims to provide durable responses against cancer and autoimmune diseases by selectively modulating different T cell subsets.

The STAR™ platform, a key component of Marengo's technology, uses multispecific antibody-fusion to target specific TCR Vβ regions. This novel method aims to activate and expand tumor-reactive T cells non-clonally, promoting strong and lasting anti-tumor immune responses.

Invikafusp alfa, or STAR0602, is the inaugural clinical candidate from Marengo's STAR™ platform. It uniquely targets tumor-associated Vβ T cell subsets, combining non-clonal TCR activation with T cell co-stimulation within a single molecule. This mechanism is designed to enhance the activity of effector memory T cells against tumors. As part of the STARt-002 trial, invikafusp alfa is being evaluated both as a monotherapy and in combination with other treatments, potentially paving the way for groundbreaking advancements in breast cancer therapy.

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