Testing EIS-12656 for advanced solid tumors
Official 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
Run by Eisbach Bio GmbH · NCT06525298 · Data updated 2026-11-12
This study is testing a new drug called EIS-12656 to see if it can safely help people with advanced solid tumors that have certain genetic mutations.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 240 (estimated) |
| Sponsor | Eisbach Bio GmbH Industry-sponsored |
| Drugs / interventions | Radiation |
| Locations | 4 sites (Shreveport, Louisiana and 3 other locations) |
| Status | Recruiting |
| Started | September 9, 2024 |
| Main results expected | September 2028 |
| Study ends | December 2028 |
| Registry record updated | November 10, 2026 |
| Trial ID | NCT06525298 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include patients with recurrent locally advanced or metastatic solid tumors that have homologous recombination deficiency mutations.
✕Probably not a fit
Patients with significant cardiovascular disease or uncontrolled brain metastases may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This trial investigates the safety and efficacy of a new drug, EIS-12656, in patients with advanced solid tumors that have specific genetic mutations. It consists of a Phase 1 dose escalation to determine the optimal dose and a Phase 2 expansion to evaluate the drug's effectiveness alone or in combination with other therapies. Participants will be monitored for safety, tolerability, and anti-tumor activity throughout the trial.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors that are difficult to treat.
How similar studies have gone: Other studies have shown promise with similar approaches targeting homologous recombination deficiencies, indicating potential for success.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
LSU Health Sciences Center- Shreveport
Shreveport, Louisiana, United States Recruiting -
Duke Cancer Institute
Durham, North Carolina, United States Recruiting -
MD Anderson Cancer Center
Houston, Texas, United States Recruiting -
Fred Hutchinson Cancer Center
Seattle, Washington, United States Recruiting
Study contacts
- Study coordinator: Adrian Schomburg
- Email: adrian@eisbach.bio
- Phone: +49 17621046886
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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This study is testing a new oral treatment called MOMA-313 for people with advanced solid tumors that can't be cured, to see how safe it is and how well it works, especially for those with certain genetic changes.
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This study tests personalized dendritic cell injections, with or without immune checkpoint inhibitors, to see if they are safe and can help patients with advanced solid tumors.
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ARV-6723 alone or with pembrolizumab in adults with advanced solid tumors
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.