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

Part of paid clinical trials in Houston, Texas.

Sponsor
Eisbach Bio GmbH
Study ID
NCT06525298
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Advanced Solid Tumor
  • HRR Deficiency
  • Homologous Recombination Deficiency

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • EIS-12656 — DRUG
    EIS-12656 tablets given daily
  • Olaparib — DRUG
    as per USPI/SmPC
  • Trastuzumab deruxtecan — DRUG
    as per USPI/SmPC

Study Details

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).

Key Dates

Start date
Sep 9, 2024
Status verified
Sep 2024
Primary completion
Sep 30, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
144 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: EIS-12656 Dose Escalation
  • Experimental: Dose Expansion Module 1 (EIS-12656 Monotherapy)
  • Experimental: Dose Expansion Module 2 (EIS-12656 + Olaparib)
    EIS-12656 will be given in combination with Olaparib
  • Experimental: Dose Expansion Module 3 (EIS-12656 + T-DXd)
    EIS-12656 will be given in combination with Trastuzumab deruxtecan

Primary Outcome Measure

Number and percentage of participants experiencing treatment-emergent adverse events (TEAEs) [ Time Frame: From screening until end of treatment follow-up (45 days after last dose) (up to 7 months) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
MD Anderson Cancer CenterHoustonTexas77030
Timothy Yap
[email protected]
713-563-1784

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By research site
MD Anderson Cancer Center· Houston, TX

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