At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed metastatic or unresectable malignancy for which standard curative measures do not exist or are no longer effective
- ✓Actionable aberration in one or more DDR genes (ARID1A, ATM, ATR, ATRX, BAP1, BARD1, BRCA1/2, BRIP1, CDK12, CHEK2, FANCA, FANCC, FANCD2, FANCE, FANCF, FANCM, MRE11A, MSH2, NBN, PALB2, RAD51, RAD51C, RAD51D, SMARCB1, VHL, or related genes at PI discretion)
- ✓At least 1 prior line of systemic therapy in advanced/metastatic setting (or declined standard of care)
- ✓Mandatory archival tumor tissue within 1 year prior to enrollment and mandatory tumor biopsy on cycle 1 day 15
- ✕Symptomatic brain metastases requiring steroids; previously treated brain metastases allowed if completed treatment, recovered from acute effects, off steroids for ≥4 weeks, and neurologically stable
- ✕Anticancer systemic therapy or radiotherapy within 4 weeks or 5 half-lives (whichever shorter) prior to study start; prior palliative radiotherapy allowed if completed ≥2 weeks prior
- ✕Major surgery within 4 weeks prior to enrollment
- ✕Known history of immune-mediated colitis, inflammatory bowel disease, pneumonitis, or pulmonary fibrosis
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
DNA Damage Repair (DDR) Inhibitor-Based Basket of Baskets Phase I/II Trial in Patients With Advanced Solid Tumors Harboring Aberrations in DDR Genes (D-BoB)
In Brief
A Phase 1 clinical trial evaluating Avelumab and Berzosertib for Metastatic Malignant Solid Neoplasm and 2 related conditions. Active but no longer recruiting, targeting 23 participants across 1 site.
Signals
Detailed Summary
This phase I/II trial studies the side effects and best dose of avelumab with M6620 in treating patients with deoxyribonucleic acid (DNA) damage repair (DDR) deficient solid tumors that have spread to other places in the body (metastatic) or cannot be removed by surgery (unresectable). DDR deficiency refers to a decrease in the ability of cells to respond to damaged DNA and to repair the damage, which can be caused by genetic mutations. Immunotherapy with monoclonal antibodies, such as avelumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. M6620 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving avelumab together with M6620 may help to control DDR deficient metastatic or unresectable solid tumors.
Study Details
Timeline
Arms & Interventions
Berzosertib 240 mg/m2 once weekly + Avelumab 800 mg IV on days 1 and 15 of each 28-day cycle
Berzosertib 480 mg/m2 once weekly + Avelumab 800 mg IV on days 1 and 15 of each 28-day cycle
Berzosertib 240 mg/m2 once weekly + Avelumab 800 mg IV on days 1 and 15 of each 28-day cycle
Berzosertib 480 mg/m2 once weekly + Avelumab 800 mg IV on days 1 and 15 of each 28-day cycle
Interventions
Given IV
Given IV