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

ConditionsAdvanced Solid TumorHomologous Recombination DeficiencyHRR Deficiency
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorEisbach Bio GmbH

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

History or evidence of any clinically relevant gastrointestinal disease

Radiation therapy within ≤2 weeks

Significant cardiovascular disease

Uncontrolled, active, symptomatic brain metastases

Trial design

Design model

Sequential

Treatments tested in this trial

  • EIS-12656

    Drug

    EIS-12656 tablets given daily

  • Olaparib

    Drug

    as per USPI/SmPC

  • Trastuzumab deruxtecan

    Drug

    as per USPI/SmPC

Treatment groups

144 Participants
are divided into 4 treatment groups
Group A: EIS-12656 Dose EscalationExperimental treatment 1 intervention
Group B: Dose Expansion Module 1 (EIS-12656 Monotherapy)Experimental treatment 1 intervention
Group C: Dose Expansion Module 2 (EIS-12656 + Olaparib)Experimental treatment 2 interventions
Group D: Dose Expansion Module 3 (EIS-12656 + T-DXd)Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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)

Time frame
From screening until end of treatment follow-up (45 days after last dose) (up to 7 months)
2

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

Time frame
Within 21 days of first dose

Secondary outcomes

1

Maximum plasma concentration of EIS-12656 (Cmax)

The concentration of EIS-12656 in plasma will be determined (Cmax will be derived)

Time frame
At pre-defined intervals from pre-dose Day 1 to Day 29
2

Area under the curve (AUC0-24)

The AUC0-24 reflects the actual body exposure to drug over the last 24h dosing interval

Time frame
At pre-defined intervals from pre-dose Day 1 to Day 29
3

Time to maximum concentration (Tmax)

The concentration of EIS-12656 in plasma will be determined (Tmax will be derived)

Time frame
At pre-defined intervals from pre-dose Day 1 to Day 29
4

Overall Response Rate

Overall response rate defined as percentage of participants with the best overall response of confirmed CR or confirmed PR according to RECIST v1.1

Time frame
From screening to disease progression (approximately 1 year)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Eisbach Bio GmbH

Lead sponsor

Source ClinicalTrials.gov
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