Phase IbII Study of PM14 Given Alone or with Radiotherapy for Soft Tissue Sarcomas and Other Solid Tumors

What this Trial Is About

Researchers are evaluating different infusion schedules of PM14, a drug administered intravenously, in patients with advanced soft tissue sarcomas and other solid tumors. This international, multicenter Phase IbII trial includes six patient groups, focusing on both monotherapy and combination treatment with radiotherapy. The study aims to find optimal dosing schedules to improve efficacy while maintaining similar side effects. It also assesses progression-free survival, overall response rates, and safety across various sarcoma subtypes and tumor locations. The trial includes several cohorts Cohorts A and B test PM14 monotherapy at different infusion durations and doses to find the recommended Phase II dose. Cohorts E and F evaluate PM14 monotherapy at this dose in specific sarcoma types. Cohorts C and D combine PM14 with radiotherapy, using different radiation doses and schedules, administered through a central venous port. Premedication with dexamethasone is recommended before treatment. Treatments continue in 21-day cycles until disease progression or unacceptable side effects occur. Participants will undergo regular assessments including imaging scans to measure tumor response and disease progression, blood tests to monitor safety, and quality of life questionnaires. The study tracks progression-free survival rates at 6 months, overall response rates in irradiated tumors, and pathological responses after treatment. Safety is closely monitored throughout, with follow-up periods extending up to three years in some cohorts. The total duration of participation varies depending on the cohort and treatment response.

Multicohort Trial of Different Schemes of PM14 in Monotherapy and in Combination with Radiotherapy in Soft Tissue Sarcomas and Other Solid Tumor