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

Sponsor: Eisbach Bio GmbH

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06525298

Patient View

This Phase 1/2 open-label trial assesses EIS-12656's safety and efficacy in patients with advanced solid tumors with HRD mutations. Phase 1 involves dose escalation to determine RP2D. Phase 2 explores EIS-12656 alone or with PARPi/T-DXd. Eligible participants have progressed on prior treatments, have measurable disease, and meet specific health criteria.

Patient Parameters

Program Overview

This trial investigates a new drug, EIS-12656, in participants with specified advanced solid tumors carrying pre-specified mutations. The trial consists of a dose escalation part (Phase 1) and a dose expansion part (Phase 2).

Description

The trial is a Phase 1/2, open label, uncontrolled trial to investigate the safety and preliminary efficacy of EIS-12656 alone or in combination with a PARPi or T-DXd in patients with specified advanced or metastatic solid tumors with homologous recombination deficient (HRD) mutations.

In the Phase 1 dose escalation phase participants will receive ascending doses of EIS-12656 to evaluate the safety and tolerability and to determine an effective and safe dose for the Phase 2 part.

In the Phase 2 dose expansion phase participants will either receive EIS-12656 monotherapy at the recommended Phase 2 dose (RP2D) (Module 1) or EIS-12656 in combination with a PARPi or T-DXd (Modules 2 and 3). The objective is to evaluate the safety and tolerability and anti-tumor activity of EIS-12656 alone or in combination.

Eligibility 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

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