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
This trial does not accept healthy volunteersQualifiers
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
Design model
Sequential
Treatments tested in this trial
ZE94-0605
DrugOral capsules QD
Treatment groups
60 Participants
are divided into 8 treatment groups8
Treatment groupsSee each treatment group below.
Group A: ZE94-0605 Dose Level -1Experimental treatment 1 intervention
Group B: ZE94-0605 Dose Level 1Experimental treatment 1 intervention
Group C: ZE94-0605 Dose Level 2Experimental treatment 1 intervention
Group D: ZE94-0605 Dose Level 3Experimental treatment 1 intervention
Group E: ZE94-0605 Dose Level 4Experimental treatment 1 intervention
Group F: ZE94-0605 Dose Level 5Experimental treatment 1 intervention
Group G: ZE94-0605 Selected dose 1Experimental treatment 1 intervention
Group H: ZE94-0605 Selected dose 2Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Recommended Phase 2 Dose of ZE94-0605
To determine the recommended phase 2 dose (RP2D) of ZE94-0605 in relapsed/refractory select solid tumor patients ≥ 18 years of age with CCNE1 amplification (or other molecular/cellular feature determined at a later time).
Time frame
From baseline up to Cycle 26 (28-day cycles)2
The incidence of DLTs
To determine a maximally tolerated dose (MTD) of ZE94-0605 in relapsed/refractory select solid tumor patients.
Time frame
From baseline to day 28.Secondary outcomes
1
Overall Response Rate
To estimate the overall response rate (CR/PR) of patients with different tumor types without and with CCNE1 amplification treated withZE94-0605. Response will be followed occur after completion of cycle 3, 5, 7, 10 and 13 and then every 6 months thereafter. Assessment of clinical response will be made according to the RECIST guidelines, version 1.1.
Time frame
From baseline up to Cycle 26 (28-day cycles)2
Duration of Response by CCNE1 Amplification Status
To estimate the duration of response for patients treated with ZE94-0605 with/without CCNE1 amplification. Response will be followed occur after completion of cycle 3, 5, 7, 10 and 13 and then every 6 months thereafter. Assessment of clinical response will be made according to the RECIST guidelines, version 1.1.
Time frame
From baseline up to Cycle 26 (28-day cycles)3
Overall Survival
Overall survival defined as the time from first dose of ZE94-0605 to death.
Time frame
From baseline up to Cycle 26 (28-day cycles)4
Plasma Cmax
ZE94-0605 peak plasma concentration
Time frame
Throughout Cycle 1 and Cycle 2 (each cycle is 28 days)Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: