Clinical trial NCT06525298: EIS-12656 as Single Agent and in Combination in Patients With Specified Solid Tumors
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Advanced Solid Tumor
Homologous Recombination Deficiency
HRR Deficiency
Lead sponsor: Eisbach Bio GmbH
Sponsor class: INDUSTRY
First posted: 2024-07-29
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number and percentage of participants experiencing treatment-emergent adverse events (TEAEs)
timeFrame: From screening until end of treatment follow-up (45 days after last dose) (up to 7 months)
measure: Number and percentage of participants experiencing a dose limiting toxicity (DLT) (dose escalation part only)
timeFrame: Within 21 days of first dose
Secondary outcomes:
measure: Maximum plasma concentration of EIS-12656 (Cmax)
timeFrame: At pre-defined intervals from pre-dose Day 1 to Day 29
measure: Area under the curve (AUC0-24)
timeFrame: At pre-defined intervals from pre-dose Day 1 to Day 29
measure: Time to maximum concentration (Tmax)
timeFrame: At pre-defined intervals from pre-dose Day 1 to Day 29
measure: Overall Response Rate
timeFrame: From screening to disease progression (approximately 1 year)
measure: Duration of Response
timeFrame: From screening to disease progression or death (approximately 1 year)
measure: Progression Free Survival
timeFrame: From screening to disease progression or death (approximately 1 year)
Other outcomes:
Locations:
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Timothy Yap
role: PRINCIPAL_INVESTIGATOR
References: