Actively Recruiting
A Phase 1/2 Trial of EIS-12656 Alone and in Combination With PARP Inhibitor or Trastuzumab Deruxtecan in Specified Solid Tumors
Led by Eisbach Bio GmbH · Updated on 2024-09-19
144
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a new drug called EIS-12656 in people with advanced or metastatic solid tumors that have specific homologous recombination deficient mutations. This Phase 1/2 trial aims to understand the safety, tolerability, and early effectiveness of EIS-12656 alone or combined with other cancer drugs such as a PARP inhibitor or Trastuzumab deruxtecan. The study focuses on patients who have progressed after at least one prior treatment or cannot tolerate other effective therapies. The study has two parts: a Phase 1 dose escalation phase where participants receive increasing doses of EIS-12656 to find a safe and effective dose, followed by a Phase 2 dose expansion phase. In Phase 2, participants receive either EIS-12656 alone at the recommended dose or in combination with Olaparib (a PARP inhibitor) or Trastuzumab deruxtecan. EIS-12656 is given daily as tablets, and other drugs are given as per their standard usage guidelines. Participants will be monitored from the start of screening through treatment and follow-up periods lasting up to 7 months or more. Researchers will track side effects, dose-limiting toxicities, drug levels in the blood, tumor response, and progression-free survival. Safety is closely observed during and after treatment, including up to 45 days post last dose. The study includes regular assessments such as imaging and laboratory tests to evaluate treatment impact and participant health throughout the trial.
CONDITIONS
Brief Title
EIS-12656 as Single Agent and in Combination in Patients With Specified Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Recurrent locally advanced or metastatic solid tumors
- Presence of homologous recombination deficient mutations
- Progressed after at least one prior treatment or intolerant to other effective therapies
- Measurable disease according to RECIST 1.1 criteria
- Adequate organ and bone marrow function
- ECOG Performance Status of 0 or 1
- Life expectancy greater than 3 months
You will not qualify if you...
- History or evidence of any clinically relevant gastrointestinal disease
- Radiation therapy within 2 weeks prior to study
- Significant cardiovascular disease
- Uncontrolled, active, symptomatic brain metastases
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 21 days
Participants receive escalating doses of EIS-12656 to evaluate safety and determine an effective dose for Phase 2.
Visits as needed during dose escalation
Duration - Up to 7 months or until disease progression or unacceptable toxicity
Participants receive EIS-12656 alone or in combination with Olaparib or Trastuzumab deruxtecan to evaluate safety, tolerability, and anti-tumor activity.
Regular visits throughout treatment period
Duration - 45 days after last dose
Participants are monitored for safety and treatment-emergent adverse events after the last dose of study drugs.
1 to 2 visits
Trial Site Locations
Total: 1 location
1
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
A
Adrian Schomburg
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here