
Clinical-stage biotechnology company Marengo Therapeutics has announced that it has dosed the first patient in Phase II of its STARt-001 trial (NCT05592626).
Phase II of the open-label, multi-centre trial study has expanded beyond the original North American sites to include oncology clinical research centres in Europe, including the initial activation of sites in France and Spain.
The trial is evaluating T cell activator invikafusp alfa (STAR0602) as an intravenously administered monotherapy in biomarker-enriched patients with advanced PD-1 resistant solid tumours. Phase I of the trial assessed dose escalation while Phase II will examine dose expansion.
The launch of Phase II follows promising Phase I data, shared at the SITC Annual Meeting and during a presentation at the 2024 ESMO Immuno-Oncology Congress, which took place earlier this month.
Marengo announced that in Phase I of the STARt-001 trial, invikafusp alfa had demonstrated a 25% overall response rate (ORR) and a 50% disease control rate (DCR) in patients with PD-1 resistant tumours with high tumour mutation burden. The results included confirmed responses in microsatellite-stable colorectal cancer.
“The single-agent anti-tumour activity observed in Phase I, particularly in PD-1-resistant ‘cold’ tumours like colorectal cancer, gives us confidence in our approach and fuels our hope to reach as many patients as possible,” said Marengo chief development officer Ke Liu.
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By GlobalDataThe company considers the T cell activator to have potential as a treatment option for high tumour mutation burden (TMB-H) cancers or virally associated malignancies.
Marengo’s Phase II clinical trial will treat patients with the recommended Phase II dose (RP2D) – 0.08mg/kg. It is currently enrolling patients in Europe at leading oncology centres, beginning in France and Spain.
Of the global expansion of the trials, Liu commented: “The addition of renowned European institutions expands our geographical footprint and enhances our ability to enrol more PD-1 resistant patient populations. Through our Phase II study, we aim to deepen our understanding of invikafusp alfa’s mechanism of action across diverse tumour types.”
Invikafusp alfa was generated from Marengo’s STAR platform. The platform is a library of antibodies that target non-clonal variable Vβ regions of the T cell receptor, fused to different co-stimulatory moieties.
Marengo reported that it has done extensive preclinical testing on invikafusp alfa ahead of the Phase I/II trial. It saw anti-tumour activity in both mouse and human ex vivo tumour models, but the Phase I STARt-001 trial was the first-in-human (FIH) testing.
According to GlobalData’s ‘Clinical Trial Descriptors Trends Insight Report Overview‘ report, oncology was the largest therapy area within FIH trials, as of September 2023. Oncology was followed by infectious diseases and the central nervous system for some trials. According to GlobalData’s clinical trial database, there are 1,540 ongoing FIH clinical trials in oncology across 3,359 sites at the time of writing.
GlobalData is the parent company of Clinical Trials Arena.