Eisbach Bio GmbH
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).
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 advanced or metastatic solid tumors with homologous recombination deficient (HRD) mutations. In the Phase 1 dose escalation phase participants will receive ascending doses of EIS-12656 to evaluate the safety and tolerability and to determine an effective and safe dose for the Phase 2 part. In the Phase 2 dose expansion phase participants will either receive EIS-12656 monotherapy at the recommended Pha…
Inclusion Criteria: * 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 Criteria: * History or evidence of any clinically relevant gastrointestinal disease * Radiation therapy within ≤2 weeks * Significant cardiovascular disease * Uncontrolled, active, symptomatic brain metastases
EIS-12656 tablets given daily
as per USPI/SmPC
as per USPI/SmPC
Arctuva estimate
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