Study on EIS-12656 Alone and in Combination for Patients with Certain Advanced Solid Tumors

Sponsor: Eisbach Bio GmbH

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06525298

Provider View

This clinical trial is testing a new drug, EIS-12656, to see if it is safe and effective for treating certain advanced solid tumors with specific genetic mutations. The study has two parts: one to find the right dose and another to test the drug alone or with other treatments.

Patient Parameters

Program Overview

The purpose of this study is to evaluate a new drug, EIS-12656, in patients with certain advanced solid tumors that have specific genetic mutations. The trial is divided into two phases. In Phase 1, researchers will test different doses of EIS-12656 to find a safe and effective amount. In Phase 2, they will test the drug at the recommended dose, either by itself or in combination with other treatments, to see how well it works against tumors.

Description

This clinical trial is designed to test the safety and effectiveness of a new drug called EIS-12656 for patients with advanced or metastatic solid tumors that have specific genetic mutations known as homologous recombination deficient (HRD) mutations.

The study has two main parts:

  • Phase 1 (Dose Escalation): Participants will receive increasing doses of EIS-12656 to determine the safest and most effective dose to use in the next phase.

  • Phase 2 (Dose Expansion): Participants will receive EIS-12656 at the recommended dose. Some will receive the drug alone, while others will receive it in combination with other treatments, such as a PARP inhibitor or T-DXd. The goal is to assess the safety, tolerability, and effectiveness of EIS-12656 alone or in combination with these treatments.

Eligibility Criteria

Inclusion Criteria

  • Have advanced or metastatic solid tumors that have come back or spread.
  • Have specific genetic mutations known as homologous recombination deficient (HRD) mutations.
  • Have tried at least one previous treatment or cannot tolerate standard treatments.
  • Have measurable tumors that can be tracked using standard criteria.
  • Have good organ and bone marrow function.
  • Be in good overall health with a performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Have a life expectancy of more than 3 months.

Exclusion Criteria

  • Have a history or current evidence of significant gastrointestinal disease.
  • Have received radiation therapy within the last 2 weeks.
  • Have significant heart disease.
  • Have uncontrolled, active, or symptomatic brain metastases.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.