Marengo Therapeutics Advances STARt-002 Clinical Trial into Phase 2 Cohort Expansion Evaluating Invikafusp Alfa with TROP2-Directed ADC TRODELVY® in Metastatic Breast Cancer
Completion of Phase 1b safety run-in and determination of recommended Phase 2 dose (RP2D) enables advancement into expansion cohorts for both hormone receptor-positive, HER2-negative (HR+/HER2−) and triple-negative (mTNBC) and metastatic breast cancer patients
Early signs of anti-tumor activity observed, including confirmed partial response (PR) and tumor regressions, with this first-in-class T-cell agonist combined with Trop2-directed ADC.
STARt-002 continues enrollment across leading North American breast cancer centers
Cambridge, Mass., September 18, 2025 – Marengo Therapeutics, Inc., a clinical-stage biotechnology company pioneering novel approaches for precision immunotherapy in oncology, inflammation and immunology (I&I), today announced 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. 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.
“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.
About Marengo Therapeutics
Marengo Therapeutics, Inc., a clinical-stage biotech company, develops novel TCR-targeting antibodies that selectively modulate common and disease-specific T cell subsets of the germline TCR repertoire to provide lifelong protection against cancer and autoimmune diseases. With a passionate team of dedicated scientists experienced in immunology and oncology, and three proprietary platforms: Selective T Cell Activation Repertoire (STAR), Trispecific T Cell Engager (Tri-STAR) and T cell Depletor (MSTAR), Marengo is working to selectively target the right T cells in the right patients to create a world in which everyone’s immune system can defeat cancer and autoimmune diseases. To learn more, visit marengotx.com.
About the STAR™ Platform
Marengo’s STAR™ Platform is a multi-specific antibody-fusion platform derived from Marengo’s proprietary library of antibodies targeting germline-encoded variable Vβ regions of the TCR fused to different T cell co-stimulatory moieties. Combining a novel non-clonal mode of TCR activation with a T cell co-stimulator in the same molecule promotes a distinct mechanism of action that promotes durable anti-tumor Vβ T cell responses.
About Invikafusp alfa (STAR0602)
Invikafusp alfa (STAR0602) is the lead candidate from Marengo’s STAR™ platform. It is designed to selectively activate a common Vβ T cell subset found in all cancers by combining a non-clonal mode of TCR activation with a T cell co-stimulatory signal in a single molecule. This innovative approach promotes the expansion of clonally diverse, effector memory Vβ T cells, enhancing anti-tumor immunity and enabling durable tumor clearance. Extensive preclinical studies demonstrate STAR0602’s potent anti-tumor activity in both mouse and human ex vivo models via a novel mechanism of action.
About the STARt-002 Trial
STARt-002 (NCT06827613) is a Phase 1b/2, open-label, multicenter study investigating the combination of invikafusp alfa and TRODELVY® in patients with unresectable, locally advanced, or metastatic breast cancer. The trial consists of a safety lead-in phase followed by two dose-expansion cohorts: one in triple-negative breast cancer (mTNBC) and one in HR+/HER2− metastatic breast cancer. More information is available at clinicaltrials.gov.
Media Contact:
Peg Rusconi | peg.rusconi@deerfieldgroup.com
Investor Contact:
Svetlana Makhni | smakhni@marengotx.com