Monopar Therapeutics Inc. will present data from its ongoing Phase 1b open-label, dose-escalating clinical trial of camsirubicin in patients with advanced soft tissue sarcoma (ASTS) later on November 1, 2023 Connective Tissue Oncology Society (CTOS) Annual Meeting, which is bringing together the world's leading sarcoma specialists. Clinical Trial Results To-Date: The Phase 1b clinical trial has enrolled 14 ASTS patients (9 female and 5 male) to-date ranging in age from 26 to 81 years (median = 52.5 years) across five dose cohorts. The trial is currently ongoing and is in the fifth dose level cohort (650 mg/m2).

So far, 9 out of the 14 patients have had stable disease (SD, as defined by RECIST 1.1 criteria) after camsirubicin treatment. All patients in the fourth and fifth cohorts achieved stable disease, including the three most recently treated patients, each of whom also experienced an ~20% tumor size reduction at last study scan. One of these patients had unresectable cancer at study entry, but after the tumor size reduction, the patient became eligible for resection and underwent successful surgical removal of their cancer with clear margins.

No dose-limiting toxicity, as defined in the protocol, has been observed to-date. A medically complex patient in the 650 mg/m2 dose cohort has an ongoing left ventricular ejection fraction (LVEF) decrease that is being monitored. This patient has a BMI of 42.5, one kidney, hypertension, a long standing heart murmur, and a maternal history of heart failure.

No toxicities have occurred requiring expansion of a dose cohort, and the maximum tolerated dose (MTD) has not been reached.