EIS-12656 as Single Agent and in Combination in Patients With Specified Solid Tumors
- Conditions
- Advanced Solid TumorHRR DeficiencyHomologous Recombination Deficiency
- Interventions
- Registration Number
- NCT06525298
- Lead Sponsor
- Eisbach Bio GmbH
- 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 expansion part (Phase 2).
- 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 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 144
- 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
- History or evidence of any clinically relevant gastrointestinal disease
- Radiation therapy within ≤2 weeks
- Significant cardiovascular disease
- Uncontrolled, active, symptomatic brain metastases
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Dose Expansion Module 1 (EIS-12656 Monotherapy) EIS-12656 - Dose Expansion Module 3 (EIS-12656 + T-DXd) EIS-12656 EIS-12656 will be given in combination with Trastuzumab deruxtecan EIS-12656 Dose Escalation EIS-12656 - Dose Expansion Module 2 (EIS-12656 + Olaparib) EIS-12656 EIS-12656 will be given in combination with Olaparib Dose Expansion Module 2 (EIS-12656 + Olaparib) Olaparib EIS-12656 will be given in combination with Olaparib Dose Expansion Module 3 (EIS-12656 + T-DXd) Trastuzumab deruxtecan EIS-12656 will be given in combination with Trastuzumab deruxtecan
- Primary Outcome Measures
Name Time Method Number and percentage of participants experiencing treatment-emergent adverse events (TEAEs) From screening until end of treatment follow-up (45 days after last dose) (up to 7 months) 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)
Number and percentage of participants experiencing a dose limiting toxicity (DLT) (dose escalation part only) Within 21 days of first dose 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
- Secondary Outcome Measures
Name Time Method Maximum plasma concentration of EIS-12656 (Cmax) At pre-defined intervals from pre-dose Day 1 to Day 29 The concentration of EIS-12656 in plasma will be determined (Cmax will be derived)
Progression Free Survival From screening to disease progression or death (approximately 1 year) Time from first dose of EIS-12656 to progression or death, as defined by RECIST 1.1
Area under the curve (AUC0-24) At pre-defined intervals from pre-dose Day 1 to Day 29 The AUC0-24 reflects the actual body exposure to drug over the last 24h dosing interval
Time to maximum concentration (Tmax) At pre-defined intervals from pre-dose Day 1 to Day 29 The concentration of EIS-12656 in plasma will be determined (Tmax will be derived)
Duration of Response From screening to disease progression or death (approximately 1 year) Time from first response to progression or death, as defined by RECIST 1.1
Overall Response Rate From screening to disease progression (approximately 1 year) Overall response rate defined as percentage of participants with the best overall response of confirmed CR or confirmed PR according to RECIST v1.1
Trial Locations
- Locations (1)
MD Anderson Cancer Center
🇺🇸Houston, Texas, United States