Status:
RECRUITING
EIS-12656 as Single Agent and in Combination in Patients With Specified Solid Tumors
Lead Sponsor:
Eisbach Bio GmbH
Conditions:
Advanced Solid Tumor
Homologous Recombination Deficiency
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
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 ...
Detailed Description
The trial is a Phase 1/2, open label, uncontrolled trial to investigate the safety and preliminary efficacy of EIS-12656 alone or in combination with a PARPi or T-DXd in patients with specified advanc...
Eligibility Criteria
Inclusion
- 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
- ECOG Performance Status 0 or 1
- Life expectancy \> 3 months
Exclusion
- History or evidence of any clinically relevant gastrointestinal disease
- Radiation therapy within ≤2 weeks
- Significant cardiovascular disease
- Uncontrolled, active, symptomatic brain metastases
Key Trial Info
Start Date :
September 9 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
144 Patients enrolled
Trial Details
Trial ID
NCT06525298
Start Date
September 9 2024
End Date
December 1 2027
Last Update
September 19 2024
Active Locations (1)
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1
MD Anderson Cancer Center
Houston, Texas, United States, 77030