EIS-12656 as Single Agent and in Combination in Patients With Specified Solid Tumors
Advanced Solid Tumor · Homologous Recombination Deficiency · HRR Deficiency
What this study involves
The registry says this study is recruiting. Individual locations may have different availability.
- Study type
- Interventional
- Phase
- Phase 1 / Phase 2
- Age range
- 18 years - Not specified
- Sex eligible
- All sexes
- Healthy volunteers
- Not accepted
- Participants
- 240 Estimated
These are starting points, not an eligibility decision. The research team must review the full requirements.
About the research
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).
Read the full 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, T-DXd or darolutamide 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 (Module 2), or T-DXd (Modules 3), or darolutamide (Module 4). The objective is to evaluate the safety and tolerability and anti-tumor activity of EIS-12656 alone or in combination.
Who may be able to participate?
The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.
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
Treatment, groups and participation
The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.
- Assignment
- Not randomized
- Masking
- No masking
EIS-12656 Dose Escalation
Not reported in this registry record.
Drug: EIS-12656
Dose Expansion Module 1 (EIS-12656 Monotherapy)
Not reported in this registry record.
Drug: EIS-12656
Dose Expansion Module 2 (EIS-12656 + PARPi)
EIS-12656 will be given in combination with PARPi
Drug: EIS-12656 · Drug: PARPi
Dose Expansion Module 3 (EIS-12656 + T-DXd)
EIS-12656 will be given in combination with Trastuzumab deruxtecan
Drug: EIS-12656 · Drug: Trastuzumab deruxtecan
Dose Expansion Module 4 (EIS-12656 + darolutamide + ADT)
EIS-12656 will be given in combination with darolutamide and androgen deprivation therapy (ADT)
Drug: EIS-12656 · Drug: Darolutamide (BAY 1841788)
EIS-12656 DRUG
EIS-12656 tablets given daily
PARPi DRUG
as per USPI/SmPC
Trastuzumab deruxtecan DRUG
as per USPI/SmPC
Darolutamide (BAY 1841788) DRUG
as per USPI/SmPC
What researchers are measuring
Outcome measures describe what is being studied. They are not proof that a treatment works.
Primary measures
Number and percentage of participants experiencing treatment-emergent adverse events (TEAEs)
Time frame: 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)
Time frame: 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 measures
Maximum plasma concentration of EIS-12656 (Cmax)
Time frame: 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)
Area under the curve (AUC0-24)
Time frame: 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)
Time frame: 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)
Overall Response Rate
Time frame: 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
Duration of Response
Time frame: From screening to disease progression or death (approximately 1 year)
Time from first response to progression or death, as defined by RECIST 1.1
Progression Free Survival
Time frame: 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
Review the complete result tables and limitations in the official record.
Open official results ↗Research locations (4)
The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.
4 locations
LSU Health Sciences Center- ShreveportShreveport, Louisiana, United StatesRecruiting
Duke Cancer InstituteDurham, North Carolina, United StatesRecruiting
MD Anderson Cancer CenterHouston, Texas, United StatesRecruiting
Fred Hutchinson Cancer CenterSeattle, Washington, United StatesRecruiting
Study team and timeline
- Lead sponsor
- Eisbach Bio GmbH
- Study start
- Sep 9, 2024 Actual
- Primary completion
- 2028-09 Estimated
- Study completion
- 2028-12 Estimated
- First posted
- Jul 29, 2024 Actual
- Last updated
- Nov 10, 2026 Actual
Official study contacts
Official study title
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, Trastuzumab Deruxtecan (T-DXd), or Darolutamide in Patients With Specified Solid Tumors
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Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.
Retrieved: Nov 12, 2026 · Last registry update: Nov 10, 2026