RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

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

Quick Facts

Study Start:2024-09-09
Study Completion:2027-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06525298

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Recurrent locally advanced or metastatic solid tumors
  2. * Homologous recombination deficient mutations
  3. * Progressed on at least on prior line of treatment or intolerant to additional effective standard therapy
  4. * Measurable disease (RECIST 1.1 Criteria)
  5. * Adequate organ and bone marrow function
  6. * ECOG Performance Status 0 or 1
  7. * Life expectancy \> 3 months
  1. * History or evidence of any clinically relevant gastrointestinal disease
  2. * Radiation therapy within ≤2 weeks
  3. * Significant cardiovascular disease
  4. * Uncontrolled, active, symptomatic brain metastases

Contacts and Locations

Study Contact

Adrian Schomburg
CONTACT
+49 17621046886
adrian@eisbach.bio

Principal Investigator

Timothy Yap
PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center

Study Locations (Sites)

MD Anderson Cancer Center
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: Eisbach Bio GmbH

  • Timothy Yap, PRINCIPAL_INVESTIGATOR, M.D. Anderson Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09-09
Study Completion Date2027-12

Study Record Updates

Study Start Date2024-09-09
Study Completion Date2027-12

Terms related to this study

Additional Relevant MeSH Terms

  • Advanced Solid Tumor
  • Homologous Recombination Deficiency
  • HRR Deficiency