Study of ZE94-0605 in Patients With Advanced Solid Tumors, With Dose Expansion Cohorts.

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Metastatic Solid Tumor; Solid Cancer; Solid Tumor Malignancies
• Intervention / Treatment: Drug: ZE94-0605

Detailed Description

This phase 1 study will focus on dose escalation across all solid tumor patients who have no alternative therapies to determine the maximally tolerated dose (MTD) followed by a two dose level expansion (MTD and one dose below) in solid tumors who have amplified CCNE1 (or other molecular/cellular feature determined at a later time) to fulfill the guidelines set forth by project Optimus.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Ekaterina Dokukina; Phone Number: +38269728309; Email: kdokukina@eilenther.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Phase 1 Escalation cohort:

   Patients ≥ 18 with pathologically confirmed, advanced and unresectable or metastatic solid tumor refractory to, or intolerant of existing therapy(ies) known to provide clinical benefit for their condition.

   Phase 1 Expansion cohort:

   Patients ≥ 18 with pathologically confirmed, advanced and unresectable or metastatic solid tumor refractory to, or intolerant of existing therapy(ies) known to provide clinical benefit for their condition or who have declined it who have CCNE1 amplification.

2. ECOG performance status of 0-1.
3. 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).
4. Absolute Neutrophil Count (ANC) must be 1.5 x 109/L or greater, platelets 100 x 109/L or greater.
5. 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.
6. For male patients of childbearing potential having intercourse with females of childbearing potential, the willingness to abstain from heterosexual intercourse or use a protocol recommended method of contraception from the start of study treatment throughout the study treatment period and for 90 days following the last dose of either study drug. Males must also refrain from sperm donation from the start of study treatment throughout the study treatment period and for 90 days following the last dose of either dose of study drug.
7. Willingness to comply with scheduled visits, drug administration plan, imaging studies, laboratory tests, other study procedures and study restrictions.

Exclusion Criteria:

1. 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.
2. Known active Hepatitis C, Hepatitis B, or HIV.
3. Pregnancy or breast feeding.
4. Concurrent participation in an investigational drug trial with therapeutic intent defined as prior study therapy within 14 days prior to study treatment.
5. Inability to tolerate oral medications including symptomatic disease significantly affecting gastrointestinal function such as inflammatory bowel disease or resection of stomach or small bowel.
6. Patients who have received an investigational agent (for any indication) within 5 half-lives of the agent; if the half-life of the agent is unknown, patients must wait 1 week prior to first dose of study treatment. An investigational agent is one for which there is no approved indication by the United States (US) FDA.
7. Patients with psychological, familial, social, or geographic factors, other significant medical condition, laboratory abnormality that otherwise preclude them from giving informed consent, following the protocol, potentially hamper compliance with study treatment and follow-up or would confound the interpretation of the results of the trial.
8. Patients with the following will be excluded: uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, serious cardiac arrhythmia, New York Heart Association (NYHA) Class III or IV heart failure, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Patients with medical comorbidities that will preclude safety evaluation of the combination should not be enrolled.
9. Patients with QTc greater than or equal to 470ms unless patient has a pacemaker. Patients with an incomplete or complete right/left bundle branch block may participate if cleared by a cardiology evaluation for enrollment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ZE94-0605 Dose Level -1; Optional and would only be performed Dose Level 1 is poorly tolerated	Drug: ZE94-0605; Oral capsules QD
Experimental: ZE94-0605 Dose Level 1	Drug: ZE94-0605; Oral capsules QD
Experimental: ZE94-0605 Dose Level 2	Drug: ZE94-0605; Oral capsules QD
Experimental: ZE94-0605 Dose Level 3	Drug: ZE94-0605; Oral capsules QD
Experimental: ZE94-0605 Dose Level 4	Drug: ZE94-0605; Oral capsules QD
Experimental: ZE94-0605 Dose Level 5	Drug: ZE94-0605; Oral capsules QD
Experimental: ZE94-0605 Selected dose 1; The doses used in Part 2 of the study will be determined based on the data from Part 1 of the study	Drug: ZE94-0605; Oral capsules QD
Experimental: ZE94-0605 Selected dose 2; The doses used in Part 2 of the study will be determined based on the data from Part 1 of the study	Drug: ZE94-0605; Oral capsules QD

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	From baseline up to Cycle 26 (28-day cycles)
The incidence of DLTs	To determine a maximally tolerated dose (MTD) of ZE94-0605 in relapsed/refractory select solid tumor patients.	From baseline to day 28.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From baseline up to Cycle 26 (28-day cycles)
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.	From baseline up to Cycle 26 (28-day cycles)
Overall Survival	Overall survival defined as the time from first dose of ZE94-0605 to death.	From baseline up to Cycle 26 (28-day cycles)
Plasma Cmax	ZE94-0605 peak plasma concentration	Throughout Cycle 1 and Cycle 2 (each cycle is 28 days)
Plasma AUC	Area under the ZE94-0605 plasma concentration-time curve during a dosing interval	Throughout Cycle 1 and Cycle 2 (each cycle is 28 days)
Time to Reach Maximum Observed Concentration (Tmax)	Tmax is defined as the time to reach maximum observed plasma concentration.	Throughout Cycle 1 and Cycle 2 (each cycle is 28 days)
Terminal Elimination Half-Life	The terminal elimination half-life (t½) is defined as the time required for the plasma concentration to decrease by 50% during the terminal elimination phase.	Throughout Cycle 1 and Cycle 2 (each cycle is 28 days)
Assessment of serum thymidine kinase 1 (TK1)		Throughout Cycle 1 and Cycle 2 (each cycle is 28 days)
Circulating Tumor DNA Analysis by NGS	Plasma samples are collected at specified time points for circulating tumor DNA (ctDNA) analysis.	Day 1 of Cycles 1, 3 and 6 (each cycle is 28 days).

Collaborators and Investigators

• Sponsor: Eilean Therapeutics

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): May 1, 2028

Study Registration Dates

• First Submitted: March 27, 2026
• First Submitted That Met QC Criteria: April 6, 2026
• First Posted (Actual): April 13, 2026

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 6, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Metastatic Solid Tumor; CDK2 inhibitor
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Neoplastic Processes; Pathological Conditions, Signs and Symptoms; Neoplasm Metastasis
• Other Study ID Numbers: ZE94-0605-0001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No