Clinical Trial | Eisbach Bio

EIS-12656, Evaluating a first-in-class ALC1 inhibitor in advanced solid tumors

Phase 1/2 Study of EIS-12656 as a single agent and in combination in patients with specified solid tumors. This interventional clinical trial evaluates EIS-12656, an investigational ALC1 inhibitor, in patients with advanced solid tumors harboring defined DNA-repair alterations. The study is an open-label, multicenter trial designed to assess the safety, tolerability, and pharmacokinetics of the drug.

Clinical Trial

Study Overview

Study ID

NCT06525298 -Read more

Study phase

Phase 1 / Phase 2

Intervention Type

Small Molecule (Oral Tablet)

Target indication

Advanced solid tumors with defined DNA-repair alterations

Study start

September 2024

Est. enrollment

144 participants

Current Status

Recruiting

Recruiting site/s

The University of Texas MD Anderson Cancer Center -
Principal Investigator: Dr. Timothy Yap.

Study Design

This Phase 1/2 study is structured to first determine a safe and effective dose of EIS-12656, and then evaluate its safety and early signs of anti-tumor activity - both alone and in combination treatments.

The study is an open-label, non-randomized, two-stage study.

Phase 1 — Dose Escalation

Dose escalation phase valuates increasing daily oral doses of EIS-12656 to determine the Maximum Tolerated Dose (MTD) and recommended Phase 2 dose.

Phase 2 — Dose Expansion

Does expansion phase further evaluates the safety and preliminary efficacy across three modules:

Module 1: EIS-12656 Monotherapy.
Module 2: EIS-12656 in combination with PARP inhibitor.
Module 3: EIS-12656 in combination with Trastuzumab deruxtecan (Enhertu).

Our commitment to patients

At Eisbach Bio, we are committed to improving the lives of patients with cancer through rigorous science and responsible drug development. Patient safety and well-being guide our work from early discovery through clinical development. We are committed to developing and testing precision oncology therapies to expand treatment options for individuals living with cancer.

Who the Study Is For

This study is intended for adults with advanced or metastatic solid tumors that harbor homologous recombination deficiency (HRD) or homologous recombination repair (HRR) gene alterations.

Patients may be eligible if they:

Are 18 years of age or older
Have advanced or metastatic solid tumors
Have tumors with HRD-positive status or HRR gene alterations
Have tumor that has progressed after prior standard treatment, or have no satisfactory standard treatment options available

Medical Disclaimer: Participation in clinical trials involves potential risks and benefits. Eligibility for participation will be determined by study investigators according to the study protocol. Patients should consult their treating physician before considering participation in a clinical study.