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

NCT06525298 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: EIS-12656C01
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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)

  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

  Within 21 days of first dose

Secondary Outcomes (6)

• Maximum plasma concentration of EIS-12656 (Cmax)

  At pre-defined intervals from pre-dose Day 1 to Day 29

• Area under the curve (AUC0-24)

  At pre-defined intervals from pre-dose Day 1 to Day 29

• Time to maximum concentration (Tmax)

  At pre-defined intervals from pre-dose Day 1 to Day 29

• Overall Response Rate

  From screening to disease progression (approximately 1 year)

• Duration of Response

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

Study Arms (4)

EIS-12656 Dose Escalation

EXPERIMENTAL

Drug: EIS-12656

Dose Expansion Module 1 (EIS-12656 Monotherapy)

EXPERIMENTAL

Drug: EIS-12656

Dose Expansion Module 2 (EIS-12656 + Olaparib)

EXPERIMENTAL

EIS-12656 will be given in combination with Olaparib

Drug: EIS-12656; Drug: Olaparib

Dose Expansion Module 3 (EIS-12656 + T-DXd)

EXPERIMENTAL

EIS-12656 will be given in combination with Trastuzumab deruxtecan

Drug: EIS-12656; Drug: Trastuzumab deruxtecan

Interventions

EIS-12656 DRUG

EIS-12656 tablets given daily

Dose Expansion Module 1 (EIS-12656 Monotherapy); Dose Expansion Module 2 (EIS-12656 + Olaparib); Dose Expansion Module 3 (EIS-12656 + T-DXd); EIS-12656 Dose Escalation

Olaparib DRUG

as per USPI/SmPC

Dose Expansion Module 2 (EIS-12656 + Olaparib)

Trastuzumab deruxtecan DRUG

as per USPI/SmPC

Also known as: Enhertu

Dose Expansion Module 3 (EIS-12656 + T-DXd)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• History or evidence of any clinically relevant gastrointestinal disease
• Radiation therapy within ≤2 weeks
• Significant cardiovascular disease
• Uncontrolled, active, symptomatic brain metastases

Sponsors & Collaborators

• Eisbach Bio GmbH: lead

Study Sites (1)

MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Interventions

olaparib; trastuzumab deruxtecan

Study Officials

• Timothy Yap

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Adrian Schomburg

CONTACT

+49 17621046886; adrian@eisbach.bio

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2024
• First Posted: July 29, 2024
• Study Start: September 9, 2024
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)