Study of ZE94-0605 in Patients With Advanced Solid Tumors, With Dose Expansion Cohorts.
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorEilean Therapeutics
About this trial
Phase 1 Study of ZE94-0605 in solid tumors who have exhausted all treatment options and then with expansion into two dose cohorts in select solid tumor patients.
Eligibility criteria
Qualifiers
ECOG performance status of 0-1.
Adequate end-organ function as defined by: Creatinine clearance >60 ml/min, AST/ALT <3x upper limit of normal, total bilirubin <1.5x upper limit of normal (except for patients with Gilbert's disease).
Absolute Neutrophil Count (ANC) must be 1.5 x 109/L or greater, platelets 100 x 109/L or greater.
For female patients of childbearing potential, willingness to abstain from heterosexual intercourse or use a protocol-recommended method of contraception from the screening visit throughout the study treatment period and for 30 days following the last dose of either study drug.
Disqualifiers
History of alternative malignancy except for the following: adequately treated local basal cell carcinoma or squamous cell carcinoma of the skin, cervical carcinoma in situ, superficial bladder cancer, asymptomatic prostate cancer without known metastatic disease or any other cancer that has been in complete remission without treatment for ≥ 2 years prior to enrollment or that has life expectancy of 24 months and does not require therapy that confounds interpretation of data from this study. Cases where this occurs must be discussed with the medical monitor before screening for enrollment.
Known active Hepatitis C, Hepatitis B, or HIV.
Pregnancy or breast feeding.
Concurrent participation in an investigational drug trial with therapeutic intent defined as prior study therapy within 14 days prior to study treatment.
Trial design
Treatments tested in this trial
- ZE94-0605
Treatment groups
60 Participants
are divided into 8 treatment groups8
Treatment groupsSee each treatment group below.
Locations
Sponsors and collaborators
Source ClinicalTrials.gov