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RecruitingInterventionalPhase 1/Phase 2

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

NCT ID: NCT06525298Sponsor: Eisbach Bio GmbHLast updated: 2024-09-19

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).

Detailed 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.

Arms & interventions

  • DrugEIS-12656

    EIS-12656 tablets given daily

  • DrugOlaparib

    as per USPI/SmPC

  • DrugTrastuzumab deruxtecan

    as per USPI/SmPC

Outcome measures

Primary

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

    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)

    Time frame: From screening until end of treatment follow-up (45 days after last dose) (up to 7 months)

  • Number and percentage of participants experiencing a dose limiting toxicity (DLT) (dose escalation part only)

    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

    Time frame: Within 21 days of first dose

Secondary

  • Maximum plasma concentration of EIS-12656 (Cmax)

    Time frame: At pre-defined intervals from pre-dose Day 1 to Day 29

  • Area under the curve (AUC0-24)

    Time frame: At pre-defined intervals from pre-dose Day 1 to Day 29

  • Time to maximum concentration (Tmax)

    Time frame: At pre-defined intervals from pre-dose Day 1 to Day 29

  • Overall Response Rate

    Time frame: From screening to disease progression (approximately 1 year)

  • Duration of Response

    Time frame: From screening to disease progression or death (approximately 1 year)

  • Progression Free Survival

    Time frame: From screening to disease progression or death (approximately 1 year)

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
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

Study locations (1)

MD Anderson Cancer Center

Houston, Texas, 77030

Recruiting
Timothy Yap · Contact
713-563-1784TYap@mdanderson.org