Milademetan in Advanced/Metastatic Solid Tumors
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.
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
The study team can explain what participation involves.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Oct 17, 2024 · Source: ClinicalTrials.gov
Ask the study team to confirm whether enrollment is open.
Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 2
- Sponsor
- Rain Oncology Inc
- Interventions being studied
- Drug: RAIN-32
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- 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
- 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 1. QTcF at rest, where the mean QTcF interval is \> 480 milliseconds 2. Myocardial infarction within 6 months 3. Uncontrolled angina pectoris within 6 months 4. New York Heart Association Class 3 or 4 congestive heart failure 5. Uncontrolled hypertension
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Stanford University Medical CenterPalo Alto, California
- Florida Cancer SpecialistsFort Myers, Florida
- Florida Cancer SpecialistsSt. Petersburg, Florida
- Massachusetts General HospitalBoston, Massachusetts
- Dana-Farber Cancer InstituteBoston, Massachusetts
- Washington University School of MedicineSt Louis, Missouri
- Memorial Sloan-Kettering Cancer CenterNew York, New York
- Hematology Oncology Associates of Central NYSyracuse, New York
- Duke University Medical CenterDurham, North Carolina
- University of Cincinnati Medical CenterCincinnati, Ohio
- Sanford HealthSioux Falls, South Dakota
- Tennessee Oncology, PLLCNashville, Tennessee
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Oct 17, 2024. Always confirm current availability with the study team.