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

Eisbach Bio GmbH

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Homologous Recombination Deficiency; Advanced Solid Tumor; HRR Deficiency

Treatments: Drug: EIS-12656; Drug: Olaparib; Drug: Trastuzumab deruxtecan

Study type: Interventional

Funder types: Industry

Identifiers

NCT06525298

EIS-12656C01

Details and patient eligibility

About

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).

Full 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.

Enrollment: 144 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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144 participants in 4 patient groups

EIS-12656 Dose Escalation

Experimental group

Treatment:

Drug: EIS-12656

Dose Expansion Module 1 (EIS-12656 Monotherapy)

Experimental group

Treatment:

Drug: EIS-12656

Dose Expansion Module 2 (EIS-12656 + Olaparib)

Experimental group

Description:

EIS-12656 will be given in combination with Olaparib

Treatment:

Drug: Olaparib

Drug: EIS-12656

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

Experimental group

Description:

EIS-12656 will be given in combination with Trastuzumab deruxtecan

Treatment:

Drug: Trastuzumab deruxtecan

Drug: EIS-12656