MNPR-201-001 Clinical Trial
MNPR-201-001 (Clinicaltrials.gov Study Identifier NCT05043649)
Camsirubicin + Pegfilgrastim to Determine MTD in ASTS
Indication: Advanced Soft Tissue Sarcoma (ASTS)
Investigational Therapeutic: Camsirubicin with Prophylactic Pegfilgrastim for the Treatment of Advanced Soft Tissue Sarcoma
Study Type: Phase 1b Open-Label Dose-Escalation
Goal: The objectives of this program are: to establish the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of camsirubicin with prophylactic pegfilgrastim; to assess the safety profile of camsirubicin with prophylactic pegfilgrastim according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE v5.0); to assess the efficacy of camsirubicin with prophylactic pegfilgrastim as measured by progression-free survival (PFS), time to progression (TTP), overall response rate (ORR), duration of response (DoR), and overall survival (OS) and to assess pharmacokinetics (PK) of camsirubicin with prophylactic pegfilgrastim.
Status: This study is currently recruiting participants
A Phase 1b, open-label, dose-escalation clinical study evaluating the safety of camsirubicin with prophylactic pegfilgrastim in the treatment of advanced soft tissue sarcomas. Following a screening period of up to 28 days, eligible patients will receive camsirubicin through intravenous infusion (8 mg/min rate) on Day 1 of a 21-day cycle for 6 cycles. Dose will be based on the patient's body surface area (BSA). Patients who demonstrate clinical benefit (defined as stable disease or better) at the completion of 6 cycles will be allowed to continue to receive camsirubicin until disease progression or unacceptable toxicity or completion of their 16th cycle. All patients receiving camsirubicin will also receive 6 mg of prophylactic pegfilgrastim approximately 48-96 hours after each camsirubicin infusion to prevent neutropenia. Dose escalation will start at 265 mg/m2, with dose increments of 50% until a Grade 2 non-hematologic toxicity is observed at which point subsequent dose escalations will be in increments of 25% until an MTD is identified.
At each successive dose level, cohorts of 3 new patients will be entered if no DLT is observed (3+3 design) within 21 days of initial dose. If a patient treated at any dose level experiences a DLT, a total of up to 6 patients will be treated at that dose level. Once two patients at any dose level experience a DLT, no additional patients will be treated at that level. The MTD is defined as the highest dose level below the dose level at which 2 or more patients experience a DLT during the first 21 days from Cycle 1 Day 1. This will be the RP2D unless safety concerns suggest a lower dose. Patients in each new cohort at all dose levels (i.e., all patients receiving their initial dose of camsirubicin at the designated dose level) will successfully complete one cycle of treatment prior to beginning treatment of a new cohort of patients at the next higher dose level.
The RP2D dose may be expanded by 6 patients to obtain additional PK and safety data at this dose. Patients will be followed for one year for adverse events of special interest (AESI), which includes the incidence of congestive heart failure and decreased left ventricular ejection fraction (LVEF). Patients will be followed for one year after end of treatment and AESI assessed every 3 months. Assessments will include LVEF assessment by echocardiogram or MUGA scan and measurement of Troponin-T. LVEF assessments should be collected even if the patient will go on to other anti-cancer therapies. An echocardiogram should be performed sooner if a patient develops signs and symptoms of congestive heart failure (e.g. shortness of breath during mild exertion or when lying down, fatigue, cough (especially at night), swelling of the feet and/or ankles).