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

September 14, 2024 updated by: Eisbach Bio GmbH

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

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

144

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • MD Anderson Cancer Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: EIS-12656 Dose Escalation
Drug: EIS-12656
EIS-12656 tablets given daily
Experimental: Dose Expansion Module 1 (EIS-12656 Monotherapy)
Drug: EIS-12656
EIS-12656 tablets given daily
Experimental: Dose Expansion Module 2 (EIS-12656 + Olaparib)
EIS-12656 will be given in combination with Olaparib
Drug: EIS-12656
EIS-12656 tablets given daily
Drug: Olaparib
as per USPI/SmPC
Experimental: Dose Expansion Module 3 (EIS-12656 + T-DXd)
EIS-12656 will be given in combination with Trastuzumab deruxtecan
Drug: EIS-12656
EIS-12656 tablets given daily
Drug: Trastuzumab deruxtecan
as per USPI/SmPC
Other Names:
  • Enhertu

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 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)
Time Frame: 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
Within 21 days of first dose

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum plasma concentration of EIS-12656 (Cmax)
Time Frame: At pre-defined intervals from pre-dose Day 1 to Day 29
The concentration of EIS-12656 in plasma will be determined (Cmax will be derived)
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
The AUC0-24 reflects the actual body exposure to drug over the last 24h dosing interval
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
The concentration of EIS-12656 in plasma will be determined (Tmax will be derived)
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)
Overall response rate defined as percentage of participants with the best overall response of confirmed CR or confirmed PR according to RECIST v1.1
From screening to disease progression (approximately 1 year)
Duration of Response
Time Frame: From screening to disease progression or death (approximately 1 year)
Time from first response to progression or death, as defined by RECIST 1.1
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)
Time from first dose of EIS-12656 to progression or death, as defined by RECIST 1.1
From screening to disease progression or death (approximately 1 year)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eisbach Bio GmbH

Investigators

  • Principal Investigator: Timothy Yap, M.D. Anderson Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 9, 2024

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

July 17, 2024

First Submitted That Met QC Criteria

July 24, 2024

First Posted (Actual)

July 29, 2024

Study Record Updates

Last Update Posted (Actual)

September 19, 2024

Last Update Submitted That Met QC Criteria

September 14, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EIS-12656C01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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