Recruiting
Phase 1
Phase 2

EIS-12656

Sponsor:

Eisbach Bio GmbH

Code:

NCT06525298

Conditions

Advanced Solid Tumor

Homologous Recombination Deficiency

HRR Deficiency

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

EIS-12656

Olaparib

Trastuzumab deruxtecan

Study Details

Brief 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).

Conditions

Advanced Solid Tumor

Homologous Recombination Deficiency

HRR Deficiency

Study ID

NCT06525298

Start date

Sep 9, 2024

Status verified date

Sep, 2024

Completion date

Dec, 2027

Anticipated

Primary completion date

Sep, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

144 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

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

Interventions

EIS-12656

EIS-12656 tablets given daily

Olaparib

as per USPI/SmPC

Trastuzumab deruxtecan

as per USPI/SmPC

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) ]
  • Number and percentage of participants experiencing a dose limiting toxicity (DLT) (dose escalation part only) [ Time Frame: Within 21 days of first dose ]

Central Contacts and Locations

Central contacts

Adrian Schomburg

+49 17621046886adrian@eisbach.bio

Locations

MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Timothy Yap

713-563-1784TYap@mdanderson.org

More Information

Sponsor

Eisbach Bio GmbH

Last update posted

Sep 19, 2024

Last verified

Sep, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Eisbach Bio GmbH on 2024-09-19.