On December 2, 2025 Solu Therapeutics, a biotechnology company pioneering novel therapies to eliminate disease-driving cells in cancer, immunology, and other therapeutic areas, reported that it will present details from its first-in-human Phase 1 clinical trial of STX-0712, the company’s novel CCR2-CyTAC (Chemokine Receptor Type 2 Cytotoxicity Targeting Chimera) for the treatment of chronic myelomonocytic leukemia (CMML) and acute myeloid leukemia (AML) in a poster session at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting being held December 6–9, 2025, in Orlando, Florida.
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The poster will highlight the design of the ongoing Phase 1, open-label, multicenter study, which is evaluating STX-0712 as monotherapy in patients with refractory or resistant CMML and relapsed or refractory monocytic or monocytic-predominant AML. Primary objectives include safety, determination of dose limiting toxicities, and determination of recommended Phase 2 dose. Secondary objectives include pharmacokinetic and pharmacodynamic characterization of STX-0712, tolerability, and preliminary evidence of antitumor activity. Key elements of the study design include dose escalation using a Bayesian Optimal Interval approach, planned dose expansion, and exploratory analyses assessing CCR2+ cell depletion, biomarkers, immune cell profiling and patient-reported outcomes.
STX-0712 is a CyTAC targeting the G-Protein Coupled Receptor CCR2, a selective marker expressed at high levels on malignant monocytes in these indications, which are key drivers in certain hematologic cancers. By targeting CCR2, STX-0712 is designed to selectively eliminate these malignant cells.
Presentation Details:
Abstract Title: A First-in-Human Study of STX-0712, a CCR2+ Cytotoxicity Targeting Chimera (CyTAC), in Patients with Chronic Myelomonocytic Leukemia (CMML) and Acute Myeloid Leukemia (AML)
Presenter: Guillermo Montalban Bravo, M.D., Department of Leukemia, Division of Cancer Medicine, MD Anderson Cancer Center
Date: Sunday, December 7, 2025
Time: 6:00pm-8:00pm EST
Location: Room OCCC- West Halls B3-B4
Session: 637. Myelodysplastic Syndromes: Clinical and Epidemiological: Poster II
Abstract Number: 14421
(Press release, Solu Therapeutics, DEC 2, 2025, View Source [SID1234661065])