Milademetan in Advanced/Metastatic Solid Tumors

Stopped early · Phase 2

Conditions studied: Solid Tumors, Head and Neck Carcinoma, Cholangiocarcinoma, Sarcoma, Lung Adenocarcinoma, Bladder Urothelial Carcinoma, Stomach Adenocarcinoma, Breast Cancer Invasive, Ovarian Carcinoma, Cervical Cancer, Non Small Cell Lung Cancer, Gastric Cancer, Biliary Tract Cancer, Melanoma, Pancreas Cancer, MDM2 Gene Amplification, Testicular Germ Cell Tumor, Adrenocortical Carcinoma

In brief

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.

Key facts

Study ID

NCT05012397

Run by

Rain Oncology Inc

People needed

40

Starts

2021-11-01

Expected to finish

2023-10-15

Last updated by the study team

2024-10-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Prior treatment with a murine double minute 2 (MDM2) inhibitor
• Well-differentiated/dedifferentiated liposarcoma or intimal sarcoma/cardiac sarcoma
• Primary malignancies that required systemic antineoplastic treatment within the previous 2 years, except for localized cancers that have apparently been cured
• Has a primary malignant brain tumor of any grade or histology
• Untreated brain metastases
• Gastrointestinal conditions that could affect the absorption of milademetan, in the opinion of the Investigator
• Known HIV infection or active hepatitis B or C infection
• Major surgery ≤ 3 weeks of the first dose of milademetan
• Curative-intent radiation therapy ≤ 4 weeks or palliative radiation therapy
• Uncontrolled or significant cardiovascular disease
• QTcF at rest, where the mean QTcF interval is > 480 milliseconds
• Myocardial infarction within 6 months
• Uncontrolled angina pectoris within 6 months
• New York Heart Association Class 3 or 4 congestive heart failure
• Uncontrolled hypertension

Where it is running

• Stanford University Medical Center — Palo Alto, California, United States
• Florida Cancer Specialists — Fort Myers, Florida, United States
• Florida Cancer Specialists — St. Petersburg, Florida, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Memorial Sloan-Kettering Cancer Center — New York, New York, United States
• Hematology Oncology Associates of Central NY — Syracuse, New York, United States
• Duke University Medical Center — Durham, North Carolina, United States
• University of Cincinnati Medical Center — Cincinnati, Ohio, United States
• Sanford Health — Sioux Falls, South Dakota, United States
• Tennessee Oncology, PLLC — Nashville, Tennessee, United States
• MD Anderson Cancer Center — Houston, Texas, United States
• Northwest Medical Specialities — Tacoma, Washington, United States

Full record on ClinicalTrials.gov

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