RecruitingPhase 1Phase 2NCT06525298

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


Sponsor

Eisbach Bio GmbH

Enrollment

144 participants

Start Date

Sep 9, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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).


Eligibility

Min Age: 18 Years

Inclusion Criteria7

  • 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 Criteria4

  • 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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Interventions

DRUGEIS-12656

EIS-12656 tablets given daily

DRUGOlaparib

as per USPI/SmPC

DRUGTrastuzumab deruxtecan

as per USPI/SmPC


Locations(1)

MD Anderson Cancer Center

Houston, Texas, United States

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NCT06525298


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