A Phase 1/2 interventional study of EIS-12656 and Olaparib in Advanced Solid Tumor, Homologous Recombination Deficiency and HRR Deficiency, sponsored by Eisbach Bio GmbH. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by Eisbach Bio GmbH · Phase 1/2, Interventional, and Treatment
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 Phase 2 dose (RP2D) (Module 1) or EIS-12656 in combination with a PARPi or T-DXd (Modules 2 and 3). The objective is to evaluate the safety and tolerability and anti-tumor activity of EIS-12656 alone or in combination.
This is the only study on the registry with Eisbach Bio GmbH as lead sponsor.
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Exclusion Criteria:
Drug: EIS-12656
Drug: EIS-12656
EIS-12656 will be given in combination with Olaparib
Drug: EIS-12656 · Drug: Olaparib
EIS-12656 will be given in combination with Trastuzumab deruxtecan
Drug: EIS-12656 · Drug: Trastuzumab deruxtecan
EIS-12656 tablets given daily
as per USPI/SmPC
as per USPI/SmPC
Also known as: Enhertu
Number and percentage of participants experiencing treatment-emergent adverse events (TEAEs)
Number and percentage of participants with adverse events, serious adverse events, adverse events of special interest including changes in safety lab parameters, physical examinations, vital signs, and electrocardiogram (ECG)
Time frame: From screening until end of treatment follow-up (45 days after last dose) (up to 7 months)
Number and percentage of participants experiencing a dose limiting toxicity (DLT) (dose escalation part only)
A DLT is defined as an EIS-12656 related adverse event during the first treatment cycle that meets the criteria outlined in the study protocol
Time frame: Within 21 days of first dose
Maximum plasma concentration of EIS-12656 (Cmax)
The concentration of EIS-12656 in plasma will be determined (Cmax will be derived)
Time frame: At pre-defined intervals from pre-dose Day 1 to Day 29
Area under the curve (AUC0-24)
The AUC0-24 reflects the actual body exposure to drug over the last 24h dosing interval
Time frame: At pre-defined intervals from pre-dose Day 1 to Day 29
Time to maximum concentration (Tmax)
The concentration of EIS-12656 in plasma will be determined (Tmax will be derived)
Time frame: At pre-defined intervals from pre-dose Day 1 to Day 29
Overall Response Rate
Overall response rate defined as percentage of participants with the best overall response of confirmed CR or confirmed PR according to RECIST v1.1
Time frame: From screening to disease progression (approximately 1 year)
Duration of Response
Time from first response to progression or death, as defined by RECIST 1.1
Time frame: From screening to disease progression or death (approximately 1 year)
Progression Free Survival
Time from first dose of EIS-12656 to progression or death, as defined by RECIST 1.1
Time frame: From screening to disease progression or death (approximately 1 year)
Plan to share: No
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Studies of the drug tested here: Trastuzumab deruxtecan