On September 18, 2025 Marengo Therapeutics, Inc., a clinical-stage biotechnology company pioneering novel approaches for precision immunotherapy in oncology, inflammation and immunology (I&I), reported the completion of the safety run-in and the determination of recommended Phase 2 dose (RP2D) for its ongoing Phase 1b/2 STARt-002 trial (Press release, Marengo Therapeutics, SEP 18, 2025, View Source [SID1234656077]). The study, evaluating Marengo’s dual T-cell agonist invikafusp alfa in combination with TRODELVY (sacituzumab govitecan-hziy), Gilead’s approved TROP2-directed antibody-drug conjugate (ADC), is now advancing into two expansion cohorts in HR+/HER2− and TNBC metastatic breast cancer, respectively.
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"Breast cancer remains an area of tremendous unmet need, particularly for patients with advanced HR+/HER2− and triple-negative disease," said Erika Hamilton, M.D. FASCO, Director of Breast Cancer Research at Sarah Cannon Research Institute (SCRI). "The ability to combine a novel T cell agonist like invikafusp with a proven ADC such as sacituzumab govitecan represents an exciting step toward potentially broadening the benefit of immunotherapy-based combination regimens for patients with historically limited treatment options. The enthusiasm we’re seeing among investigators and patients to participate in STARt-002 reflects the promise of this approach."
"As highlighted at recent oral presentations at major scientific conferences, invikafusp has already demonstrated promising single-agent activity in PD-1 resistant tumors including breast cancer," said Kevin Chin, M.D., Chief Medical Officer of Marengo Therapeutics. "Advancing STARt-002 into Phase 2 expansion cohorts reinforces invikafusp’s potential as an immunotherapy backbone, particularly in combination with ADCs for immunologically cold tumors such as breast cancer. We look forward to building on this momentum as we generate additional clinical data in both monotherapy and combination settings."
The STARt-002 study (NCT06827613) is currently enrolling patients across leading North American cancer centers including Massachusetts General Hospital, SCRI, Princess Margaret Cancer Centre, University of Southern California, University of California Los Angeles, University of Texas at San Antonio and Ohio State University, with participation from additional sites in the near term.