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Clinical Trials in the USA / NCT06525298
Recruiting Phase 1/2

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

NCT06525298 · tracked via the Priya Life Science USA tracker
Sponsor
Eisbach Bio GmbH
Phase
Phase 1/2
Started
2024-09-09
Last updated
2024-09-19

Condition(s) studied

Advanced Solid TumorHomologous Recombination DeficiencyHRR Deficiency

Investigational drug(s) / intervention(s)

EIS-12656Olaparib →Trastuzumab deruxtecan →

EIS-12656: EIS-12656 tablets given daily

Olaparib: as per USPI/SmPC

Trastuzumab deruxtecan: as per USPI/SmPC

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy 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

Primary outcome measure(s)

  • 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

Trial sites (1)

FacilityCityRegionStatus
MD Anderson Cancer Center Houston Texas Recruiting

On this site

📄 Lynparza (olaparib) drug profile → 📄 Enhertu (trastuzumab deruxtecan) drug profile →

Other trials for the same condition

An Investigational Study of BG-75202 Alone and in Combination With Other Therapeutic Agents in Adults With Advanced Solid Tumors Recruiting
GI-101/GI-101A as a Single Agent or in Combination With Pembrolizumab or Lenvatinib in Advanced Solid Tumors Recruiting
Phase 1 Study of Intratumoral Administration of VAX014 With Expansion in Combination With a Checkpoint Inhibitor in Subjects With Advanced Solid Tumors Recruiting
A Study of LY4101174 in Participants With Recurrent, Advanced or Metastatic Solid Tumors Active, not recruiting
A Study of DS-1103a Combination Therapy in Participants With Advanced Solid Tumors Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06525298 on ClinicalTrials.gov ↗ ← All trials in the USA