EIS-12656 as Single Agent and in Combination in Patients With Specified Solid Tumors
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 or Trastuzumab Deruxtecan (T-DXd), an Antibody Drug Conjugate (ADC), in Participants With Specified Solid Tumors
Eisbach Bio GmbH
144 participants
Sep 9, 2024
INTERVENTIONAL
Conditions
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 expansion part (Phase 2).
Eligibility
Inclusion Criteria7
- 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 Criteria4
- History or evidence of any clinically relevant gastrointestinal disease
- Radiation therapy within ≤2 weeks
- Significant cardiovascular disease
- Uncontrolled, active, symptomatic brain metastases
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Interventions
EIS-12656 tablets given daily
as per USPI/SmPC
as per USPI/SmPC
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06525298