Phase 1 / Phase 2: testing EIS-12656 for Advanced Solid Tumor
This trial investigates a new drug, EIS-12656, in participants with specified advanced solid tumors carrying pre-specified mutations. The trial consists of a dose escalation part (Phase 1) and a dose expansion part (Phase 2).
Official registry: https://clinicaltrials.gov/study/NCT06525298 · Eisbach Bio GmbH · enrollment listed as 240
What this phase means
Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are EIS-12656, PARPi, or Trastuzumab deruxtecan. The registry lists allocation as randomized. This trial investigates a new drug, EIS-12656, in participants with specified advanced solid tumors carrying pre-specified mutations.
They plan to enroll about 240 people at 4 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.
Official title (unrewritten)
A Phase 1/2, Open Label Trial to Investigate the Safety, Tolerability, and Preliminary Efficacy of EIS-12656 as Single Agent and in Combination With a Poly-ADP Ribose Polymerase (PARP) Inhibitor, Trastuzumab Deruxtecan (T-DXd), or Darolutamide in Patients With Specified Solid Tumors
Interventions: EIS-12656, PARPi, Trastuzumab deruxtecan, Darolutamide (BAY 1841788)
Primary outcome (registry wording): Number and percentage of participants experiencing treatment-emergent adverse events (TEAEs)
Who it is for (from inclusion criteria)
- Ages 18 Years to any
- Recurrent locally advanced or metastatic solid tumors
- Homologous recombination deficient mutations
- Progressed on at least on prior line of treatment or intolerant to additional effective standard therapy
- Measurable disease (RECIST 1.1 Criteria)
- Adequate organ and bone marrow function
- how well you can do daily activities (ECOG score) 0 or 1
- Life expectancy \> 3 months
Who the registry excludes
- History or evidence of any clinically relevant gastrointestinal disease
- Radiation therapy within ≤2 weeks
- Significant cardiovascular disease
- Uncontrolled, active, symptomatic brain metastases
Public study contact (from the registry)
Adrian Schomburg
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
Sites listed on ClinicalTrials.gov
4 listed- LSU Health Sciences Center- Shreveport — Shreveport, Louisiana (recruiting)
- Duke Cancer Institute — Durham, North Carolina (recruiting)
- MD Anderson Cancer Center — Houston, Texas (recruiting)
- Fred Hutchinson Cancer Center — Seattle, Washington (recruiting)
FAQ about this NCT record
Is NCT06525298 still recruiting?
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT06525298?
Phase 1 / Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT06525298?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
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