On October 8, 2026 Solu Therapeutics, a biotechnology company pioneering novel therapies to eliminate disease-driving cells in cancer, immunology, and other therapeutic areas, reported that it has initiated dosing in an acute myeloid leukemia (AML) cohort of the ongoing Phase 1 study of STX-0712, the Company’s investigational therapeutic designed to deplete disease-driving CCR2-positive malignant monocytes and CCR2-positive bone marrow progenitors. The cohort will enroll patients with relapsed/refractory monocytic or monocytic-predominant AML.
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"Initiating dosing in the AML cohort marks an important milestone for STX-0712 and represents the next step in the development of our Phase 1 study in hematologic malignancies," said Philip Vickers, President and CEO of Solu Therapeutics. "Given the emerging data we have seen in chronic myelomonocytic leukemia and that a significant subset of AML is also driven by CCR2-positive monocytes and progenitors, we’re excited to evaluate STX-0712 as a monotherapy in this setting. With limited treatment options for patients with relapsed or refractory disease, we look forward to building a broader clinical dataset and further defining the therapeutic potential of STX-0712."
The Phase 1 study (NCT06950034) is an open-label, multicenter study evaluating the safety, tolerability, recommended Phase 2 dose and preliminary antitumor activity of STX-0712 as monotherapy in patients with relapsed/refractory chronic myelomonocytic leukemia (CMML) and AML.
About STX-0712
STX-0712 is an investigational Cytotoxicity Targeting Chimera (CyTAC) targeting the G Protein-Coupled Receptor CCR2, a selective marker expressed at high levels on malignant monocytes and bone marrow blasts, which are key drivers of disease in chronic myelomonocytic leukemia (CMML), acute myeloid leukemia (AML), and other hematologic cancers. Designed to selectively eliminate CCR2-positive cells, STX-0712 has the potential to offer a more targeted and effective treatment option with minimal effects on non-malignant cells.
STX-0712 has received Fast Track Designation from the U.S. Food and Drug Administration, and is currently being evaluated in a Phase 1 study in patients with relapsed/refractory CMML and AML.
(Press release, Solu Therapeutics, OCT 8, 2026, View Source [SID1234673297])