Testing EIS-12656 for advanced solid tumors
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 or Trastuzumab Deruxtecan (T-DXd), an Antibody Drug Conjugate (ADC), in Participants With Specified Solid Tumors
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 |
| Enrollment | 144 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Eisbach Bio GmbH Industry-sponsored |
| Drugs / interventions | Radiation |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT06525298 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include patients with recurrent locally advanced or metastatic solid tumors that have homologous recombination deficiency mutations.
Not a fit: Patients with significant cardiovascular disease or uncontrolled brain metastases may not benefit from this study.
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 performed: Other studies have shown promise with similar approaches targeting homologous recombination deficiencies, indicating potential for success.
Eligibility criteria
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 this trial is running
Houston, Texas
- MD Anderson Cancer Center — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Timothy Yap — M.D. Anderson Cancer Center
- Study coordinator: Adrian Schomburg
- Email: adrian@eisbach.bio
- Phone: +49 17621046886
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.