STARt-002 is a Phase 1b/2 clinical study assessing invikafusp alfa in combination with Gilead’s Trodelvy® for HR+/HER2- and TNBC breast cancer patients across leading U.S. and Canadian breast cancer centers
Marengo Therapeutics, Inc., a clinical-stage biotechnology company pioneering novel approaches to precision T cell activation, today announced that the first patient has been dosed in its STARt-002 clinical trial. The Phase 1b/2 study evaluates the safety and efficacy of Marengo’s lead clinical T cell agonist in combination with Trodelvy® (sacituzumab govitecan-hziy), Gilead’s approved TROP2-directed antibody-drug conjugate (ADC), in patients with metastatic breast cancer (mBC).
“The growing body of evidence supporting combinations of ADCs and immunotherapies is encouraging, including the recent success of the ASCENT-04 trial combining sacituzumab govitecan with pembrolizumab in metastatic TNBC,” said Steven Isakoff, M.D., Ph.D., Medical Oncologist and Director of Breast Cancer Clinical Research at Massachusetts General Hospital. “Invikafusp alfa is a novel bi-specific immunotherapy designed as a dual T cell agonist, and the recent AACR presentation highlighting its single-agent activity in PD-1 resistant tumors is particularly compelling. Coupled with preclinical evidence of efficacy in breast cancer models, this combination with an ADC offers a promising and innovative approach to expanding immunotherapy options for patients with both HR+/HER2- and triple-negative breast cancers.”
STARt-002 (NCT06827613) is a Phase 1b/2 trial, beginning with a run-in phase to determine the optimal tolerated combined dose of the two agents, followed by dose expansion in two patient cohorts: metastatic triple-negative breast cancer (mTNBC) and hormone receptor-positive, HER2-negative (HR+/HER2−) metastatic breast cancer.
The study is currently enrolling patients at three leading North American cancer centers: Massachusetts General Hospital, Sarah Cannon Research Institute, and Princess Margaret Cancer Centre, with additional sites expected to join soon.
“As presented in recent SITC, EMSO IO and AACR meetings, invikafusp clearly demonstrates promising monotherapy activity in PD-1 resistant tumors including MSS CRC and PD-1 negative NSCLC,” said Kevin Chin, M.D., Chief Medical Officer of Marengo Therapeutics. “These data reinforce our belief that invikafusp could serve as a best-in-class immunotherapy backbone for multiple tumor types, particularly when paired with ADCs in immunologically cold tumors such as breast cancer. We are honored to partner with world-class clinical investigators to explore this promising combination for patients with high unmet needs.”
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