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Trial Title:
EIS-12656 as Single Agent and in Combination in Patients With Specified Solid Tumors
NCT ID:
NCT06525298
Condition:
Advanced Solid Tumor
Homologous Recombination Deficiency
HRR Deficiency
Conditions: Official terms:
Neoplasms
Trastuzumab
Olaparib
Trastuzumab deruxtecan
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
EIS-12656
Description:
EIS-12656 tablets given daily
Arm group label:
Dose Expansion Module 1 (EIS-12656 Monotherapy)
Arm group label:
Dose Expansion Module 2 (EIS-12656 + Olaparib)
Arm group label:
Dose Expansion Module 3 (EIS-12656 + T-DXd)
Arm group label:
EIS-12656 Dose Escalation
Intervention type:
Drug
Intervention name:
Olaparib
Description:
as per USPI/SmPC
Arm group label:
Dose Expansion Module 2 (EIS-12656 + Olaparib)
Intervention type:
Drug
Intervention name:
Trastuzumab deruxtecan
Description:
as per USPI/SmPC
Arm group label:
Dose Expansion Module 3 (EIS-12656 + T-DXd)
Other name:
Enhertu
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
MD Anderson Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Contact:
Last name:
Timothy Yap
Phone:
713-563-1784
Email:
TYap@mdanderson.org
Start date:
September 9, 2024
Completion date:
December 2027
Lead sponsor:
Agency:
Eisbach Bio GmbH
Agency class:
Industry
Source:
Eisbach Bio GmbH
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06525298
