Metarrestin (ML-246) in Subjects With Metastatic Solid Tumors
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Advanced Breast Cancer
- Advanced Solid Tumors
- Malignant Peripheral Nerve Sheath Tumor
- Metastatic Pancreatic Cancer
- Pediatric Solid Tumor
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: Non-RandomizedIntervention Model: Sequential AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 12 years and 125 years
- Gender
- Both males and females
Description
Background: Metarrestin is a first-in-class investigational agent targeting the peri-nucleolar compartment (PNC), a marker of genome organization associated with metastasis. Preclinical studies have shown that metarrestin effectively suppresses metastasis and extends overall survival in different ca...
Background: Metarrestin is a first-in-class investigational agent targeting the peri-nucleolar compartment (PNC), a marker of genome organization associated with metastasis. Preclinical studies have shown that metarrestin effectively suppresses metastasis and extends overall survival in different cancer models. Multi-species allometric scaling and good laboratory practice (GLP) toxicology and toxicokinetic studies indicate that metarrestin administered at a calculated safe maximum recommended starting dose (MRSD) to human subjects is predicted to afford intratumoral exposure levels within the therapeutic range observed preclinically. Objectives: Phase IA: To determine the maximum tolerated dose (MTD) of metarrestin. Phase IB: To determine the Objective Response Rate (ORR) according to Evaluation Criteria (RECIST 1.1) in patients treated with metarrestin at the MTD. Eligibility: -Adult subjects with any advanced solid tumors (Cohort IA), or pancreatic or breast tumors (Cohort IB1). OR Pediatric subjects age 12 and older with solid tumors other than rhabdomyosarcoma and related skeletal muscle tumors (Cohort IB2). Patients must have progressed on prior standard chemotherapeutic therapy. Design: This is first-in-human Phase I trial to investigate the safety and clinical activity of metarrestin in subjects with metastatic solid tumors. During Phase IA MTD of metarrestin will be estimated in adult patients with solid tumors. During Phase IB adult patients with breast or pancreatic cancer and pediatric patients with solid organ cancer will be treated at dose level of estimated MTD. Patients will receive treatment in cycles consisting of 28 (+/- 3) days. Metarrestin will be administered PO until progression or unacceptable toxicity.
Tracking Information
- NCT #
- NCT04222413
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Udo Rudloff, M.D. National Cancer Institute (NCI)
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