A Phase 2 Basket Study of Milademetan in Advanced/Metastatic Solid Tumors (MANTRA-2)

Status: Terminated
Location: See all (14) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

Phase 2, multicenter, single-arm, open-label basket study designed to evaluate the safety and efficacy of milademetan in patients with advanced or metastatic solid tumors refractory or intolerant to standard-of-care therapy that exhibit wild-type (WT) TP53 and MDM2 copy number (CN) ≥ 8 using prespecified biomarker criteria.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Histologically and/or cytologically confirmed diagnosis of a cancer that is a locally advanced or metastatic solid tumor

• Measurable tumor lesion(s) in accordance with RECIST v1.1

• Received all standard therapy appropriate for their tumor type and stage of disease or, in the opinion of the Investigator, would be unlikely to tolerate or derive clinically meaningful benefit from appropriate standard-of-care therapy

• Resolution of any clinically relevant toxic effects of prior chemotherapy, surgery, radiotherapy, or hormonal therapy

• Presence of WT TP53 and MDM2 gene amplification by tumor tissue/blood testing, defined as ≥ 8 copies in tumor tissue by central laboratory or ≥ 8 copies or 4-fold increase in tumor tissue or blood by local testing

• Prescreening for TP53 and MDM2 at a Central Laboratory:

‣ MDM2 amplification: CN unknown and where CN cannot be derived for documentation by interpretation of reported results

⁃ MDM2 amplification: CN 6 to 7.9

⁃ MDM2 amplification: 3-3.9-fold increase

⁃ MDM2 amplification with CN ≥ 8 and with equivocal TP53 mutation upon discussion with Sponsor's Medical Monitor

• ECOG performance status of 0 or 1

• Adequate bone marrow function:

‣ Platelet count ≥ 100 × 10\^9/L

⁃ Hemoglobin ≥ 9.0 g/dL

⁃ Absolute neutrophil count ≥ 1.5 × 10\^9/L

• Adequate renal function

‣ Creatinine clearance ≥ 30mL/min, as calculated using the modified Cockcroft-Gault equation

• Adequate hepatic function

‣ Alanine aminotransferase and aspartate aminotransferase ≤ 3 × upper limit of normal (ULN) if no liver metastases are present; ≤ 5 × ULN if liver metastases are present

⁃ Total bilirubin ≤ 1.5 × ULN, or ≤ 3 x ULN in the presence of liver metastases

Locations
United States
California
Stanford University Medical Center
Palo Alto
Florida
Florida Cancer Specialists
Fort Myers
Florida Cancer Specialists
St. Petersburg
Massachusetts
Dana-Farber Cancer Institute
Boston
Massachusetts General Hospital
Boston
Missouri
Washington University School of Medicine
St Louis
North Carolina
Duke University Medical Center
Durham
New York
Memorial Sloan-Kettering Cancer Center
New York
Hematology Oncology Associates of Central NY
Syracuse
Ohio
University of Cincinnati Medical Center
Cincinnati
South Dakota
Sanford Health
Sioux Falls
Tennessee
Tennessee Oncology, PLLC
Nashville
Texas
MD Anderson Cancer Center
Houston
Washington
Northwest Medical Specialities
Tacoma
Time Frame
Start Date: 2021-11-01
Completion Date: 2023-10-15
Participants
Target number of participants: 40
Treatments
Experimental: Milademetan (RAIN-32)
260 mg once dailly orally on Days 1 to 3 and Days 15 to 17 of each 28-day cycle
Sponsors
Leads: Rain Oncology Inc

This content was sourced from clinicaltrials.gov