Other Mutations: POLD

NCT05071209: Elimusertib for the Treatment of Relapsed or Refractory Solid Tumors

NCT05071209
Breast Cancer Type: HER2+, HR+ & HER2-negative, Triple Negative
Hormone Mutations: ER+, PR+
Other Mutations: DNA damage repair mutations, ATM, ATR, BRCA+, CDK, MMR, POLD
Breast Cancer Tissue: 
Recruitment Status: Recruiting
Phase 1|Phase 2
Drug Category: Serine-Threonine Kinase Inhibitor

Key Eligibility Criteria:

Gender: All
Age: 12 Months to 30 Years (Child, Adult)
Location of Metastases: 
Additional Notes: Patients must be 21 years of age or younger to be eligible for Part B, and 17 years of age or younger for Part A
Exclusions: Patients with prior exposure to BAY 1895344 (elimusertib) or any other specific ATR inhibitors including berzosertib (M6620, VX-970), ceralasertib (AZD6738), M4344 (VX-803), M1774, and RP-3500; Patients with symptomatic, unstable, untreated brain metastases- see trial for details
https://ClinicalTrials.gov/show/NCT05071209

NCT04500548: Testing the Combination of Two Immunotherapy Drugs (Nivolumab and Ipilimumab) in Children, Adolescent, and Young Adult Patients With Relapsed/Refractory Cancers That Have an Increased Number of Genetic Changes, The 3CI Study

NCT04500548
Breast Cancer Type: HER2+, HR+ & HER2-negative, Triple Negative
Hormone Mutations: ER+, PR+
Other Mutations: MSI-H, MMR, Epcam+, POLD, POLE
Breast Cancer Tissue: 
Recruitment Status: Recruiting
Phase 1
Drug Category: Immunotherapy, Therapeutic Antibody

Key Eligibility Criteria:

Gender: All
Age: 12 Months to 25 Years (Child, Adult))
Location of Metastases: 
Additional Notes: Breast cancer patients are also eligible for Part 2 of the study if their tumors express 10 or greater mutations, also known as tumor mutation burden – high (TMB-H)
Exclusions: Patients who have had combined treatment of anti-PD-1/PD-L1 (e.g. Keytruda/pembrolizumab, Tecentriq/atezolizumab) & anti-CTLA-4 inhibitors (e.g. Yervoy/Ipilimumab, tremelimumab); Patients that have received monotherapy of either are still eligible
https://ClinicalTrials.gov/show/NCT04500548

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