At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed solid malignancy that is metastatic or unresectable
- ✓Genomic or immunohistochemical evidence of inactivating ATM mutations, MYC amplification, FBXW7 mutation, CCNE1 amplification, SWI/SNF member mutations, or ATRX/DAXX mutation/loss of expression
- ✓Progression on at least one prior standard therapy
- ✓Age ≥18 years
- ✕Immunotherapy within 21 days of Cycle 1 Day 1
- ✕Therapeutic radiation within 21 days or palliative radiation within 7 days of Cycle 1 Day 1
- ✕Major surgery within 21 days of Cycle 1 Day 1
- ✕Unrecovered adverse events from prior anti-cancer therapy (residual toxicities >Grade 1)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Molecularly Driven Phase 1b Dose Escalation and Dose Expansion Study of the DNA-PK Inhibitor Peposertib (M3814) in Combination With the ATR Inhibitor Tuvusertib (M1774)
In Brief
A Phase 1 clinical trial evaluating Biopsy Procedure, Biospecimen Collection, and 5 other interventions for Advanced Malignant Solid Neoplasm and 2 related conditions. Currently recruiting, targeting 66 participants across 6 sites.
Signals
Detailed Summary
This phase I trial tests the safety, side effects and best dose of peposertib (M3814) in combination with tuvusertib (M1774) in treating patients with solid tumors that have spread to other places in the body (advanced). Peposertib and tuvusertib stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Study Details
Timeline
Arms & Interventions
Patients receive peposertib PO QD or BID daily on days 2-14 of cycle 1 and days 1-14 of subsequent cycles in combination with tuvusertib PO QD daily on days 1-14 of each cycle. Cycles repeat every 28 days in the absence of disease progression, pregnancy, non-compliance, unacceptable toxicity, termination of the study or the study drug is no longer available. Patients also undergo tumor biopsy, blood sample collection, PET, CT, and MRI throughout the study.
Interventions
Undergo tissue biopsy
Undergo blood sample collection
Undergo CT
Undergo MRI
Given PO
Undergo PET
Given PO