← Back to Search

Other

EIS-12656 for Solid Tumors

Phase 1 & 2
Recruiting
Led By Timothy Yap
Research Sponsored by Eisbach Bio GmbH
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Recurrent locally advanced or metastatic solid tumors
Homologous recombination deficient mutations
Must not have
History or evidence of any clinically relevant gastrointestinal disease
Radiation therapy within 2 weeks
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from screening to disease progression (approximately 1 year)
Awards & highlights

Summary

This trial is testing a new drug called EIS-12656 in patients who have specific types of advanced solid tumors with certain genetic mutations. The trial has two parts: one where they test different doses

Who is the study for?
This trial is for individuals with advanced solid tumors that have certain genetic mutations. Participants should be adults who can take oral medication and have measurable disease per specific criteria. They must not have had prior treatments that would interfere with the study.
What is being tested?
The trial is testing EIS-12656, a new drug, alone and in combination with Trastuzumab deruxtecan or Olaparib. It has two parts: first to find the right dose (Phase 1) and then to see how well it works at that dose (Phase 2).
What are the potential side effects?
Potential side effects of these drugs may include nausea, fatigue, blood cell count changes, hair loss, nerve damage, and allergic reactions. The exact side effects of EIS-12656 are unknown since it's a new drug.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My cancer has returned or spread and is not blood-related.
Select...
My cancer has specific genetic changes known as homologous recombination deficiencies.
Select...
My condition worsened after previous treatments or I couldn't tolerate them.
Select...
I am fully active or can carry out light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have a significant gastrointestinal condition.
Select...
I have not had radiation therapy in the last 2 weeks.
Select...
I have a serious heart condition.
Select...
I have active brain cancer that is not under control.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from screening to disease progression (approximately 1 year)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from screening to disease progression (approximately 1 year) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number and percentage of participants experiencing a dose limiting toxicity (DLT) (dose escalation part only)
Number and percentage of participants experiencing treatment-emergent adverse events (TEAEs)
Secondary study objectives
Area under the curve (AUC0-24)
Duration of Response
Maximum plasma concentration of EIS-12656 (Cmax)
+3 more

Trial Design

4Treatment groups
Experimental Treatment
Group I: EIS-12656 Dose EscalationExperimental Treatment1 Intervention
Group II: Dose Expansion Module 3 (EIS-12656 + T-DXd)Experimental Treatment2 Interventions
EIS-12656 will be given in combination with Trastuzumab deruxtecan
Group III: Dose Expansion Module 2 (EIS-12656 + Olaparib)Experimental Treatment2 Interventions
EIS-12656 will be given in combination with Olaparib
Group IV: Dose Expansion Module 1 (EIS-12656 Monotherapy)Experimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Trastuzumab deruxtecan
2022
Completed Phase 2
~580
Olaparib
2007
Completed Phase 4
~2190

Find a Location

Who is running the clinical trial?

Eisbach Bio GmbHLead Sponsor
Timothy YapPrincipal InvestigatorM.D. Anderson Cancer Center
3 Previous Clinical Trials
891 Total Patients Enrolled
~96 spots leftby Sep 2027
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top