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EIS-12656 for Advanced Solid Tumors with HRD Mutations

This study is testing a new drug called EIS-12656, both by itself and in combination with other approved drugs like Olaparib or Trastuzumab deruxtecan. It's for people with advanced solid tumors that have specific genetic changes called homologous recombination deficient (HRD) mutations. You might be able to join if your cancer has progressed after at least one previous treatment, you have measurable disease, and good overall health. The main goals are to see how safe EIS-12656 is and to find the best dose. Researchers will also look at how well it works against the cancer. This study is currently recruiting up to 144 participants.

Study design
This is a Phase 1/2, open-label study, meaning both you and your doctors will know which treatment you are receiving. It will involve up to 144 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
You will be followed for treatment-emergent adverse events (side effects) from screening until 45 days after your last dose, up to 7 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06525298

EIS-12656 as Single Agent and in Combination in Patients With Specified Solid Tumors

Recruiting
PHASE1Ages 18+InterventionalTreatment
Eisbach Bio GmbH
~144 participants
Updated 2024-09-19 on ClinicalTrials.gov
What's tested:EIS-12656OlaparibTrastuzumab deruxtecan

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number and percentage of participants experiencing treatment-emergent adverse events (TEAEs)
Measured over From screening until end of treatment follow-up (45 days after last dose) (up to 7 months)
+1 more outcome measured

Conditions

Advanced Solid Tumor
Homologous Recombination Deficiency
HRR Deficiency

Explore related trials

Homologous Recombination Deficiency ScoreSolid NeoplasmAHRR Gene

Where it's being run

1 sites across 1 states
Texas1

Study leadership

  • Timothy Yap · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center

Who to contact

Adrian Schomburg
[email protected]
+49 17621046886
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

History or evidence of any clinically relevant gastrointestinal disease
Radiation therapy within ≤2 weeks
Significant cardiovascular disease
Uncontrolled, active, symptomatic brain metastases

What this trial measures

  • Number and percentage of participants experiencing treatment-emergent adverse events (TEAEs)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)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