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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EIS-12656 Dose Escalation | Experimental |
| |
| Dose Expansion Module 1 (EIS-12656 Monotherapy) | Experimental |
| |
| Dose Expansion Module 2 (EIS-12656 + Olaparib) | Experimental | EIS-12656 will be given in combination with Olaparib |
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| Dose Expansion Module 3 (EIS-12656 + T-DXd) | Experimental | EIS-12656 will be given in combination with Trastuzumab deruxtecan |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EIS-12656 | Drug | EIS-12656 tablets given daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 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 | Within 21 days of first dose |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum plasma concentration of EIS-12656 (Cmax) | The concentration of EIS-12656 in plasma will be determined (Cmax will be derived) | At pre-defined intervals from pre-dose Day 1 to Day 29 |
| Area under the curve (AUC0-24) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Adrian Schomburg | Contact | +49 17621046886 | adrian@eisbach.bio |
| Name | Affiliation | Role |
|---|---|---|
| Timothy Yap | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MD Anderson Cancer Center | Recruiting | Houston | Texas | 77030 | United States |
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| ID | Term |
|---|---|
| C531550 | olaparib |
| C000614160 | trastuzumab deruxtecan |
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| Olaparib | Drug | as per USPI/SmPC |
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| Trastuzumab deruxtecan | Drug | as per USPI/SmPC |
|
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The AUC0-24 reflects the actual body exposure to drug over the last 24h dosing interval
| 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) | 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 | 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 | 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 | From screening to disease progression or death (approximately 1 year) |