Advanced Solid Tumor CancerPhase 1NCT07524140
A First-in-Human Study of ZE94-0605 in Patients With Advanced Solid Tumors
A Phase 1 study testing ZE94-0605 in people with Advanced Solid Tumor Cancer and Metastatic Solid Tumor, run by Eilean Therapeutics at 3 sites in 2 countries.
Trial summary
ZE94-0605 is an oral, selective cyclin-dependent kinase 2 (CDK2) inhibitor. This multicenter, open-label, first-in-human Phase 1 study will evaluate ZE94-0605 in adults with advanced, unresectable or metastatic solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumor Cancer, Metastatic Solid Tumor
- What is being tested?
- ZE94-0605
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 25 Jun 2026to May 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Phase 1a Dose-Escalation Cohorts:
- Age 18 years or older with a pathologically confirmed, advanced, unresectable or metastatic solid tumor that is refractory to, or intolerant of, available existing therapy or therapies known to provide clinical benefit for the condition, if available, and with measurable disease.
- Phase 1b Dose-Expansion Cohorts:
- Age 18 years or older with a pathologically confirmed, advanced, unresectable or metastatic solid tumor that is refractory to, or intolerant of, available existing therapy or therapies known to provide clinical benefit for the condition, if available, or who has declined such therapy; presence of CCNE1 amplification; and measurable disease.
- Common Eligibility Criteria:
- Eastern Cooperative Oncology Group performance status of 0 or 1.
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- Adequate end-organ function, defined as creatinine clearance greater than 60 mL/min, aspartate aminotransferase and alanine aminotransferase less than 3 times the upper limit of normal, and total bilirubin less than 1.5 times the upper limit of normal, except for participants with Gilbert's disease.
- Absolute neutrophil count at least 1.5 × 10^9/L and platelet count at least 100 × 10^9/L.
- Female participants of childbearing potential must be willing to abstain from heterosexual intercourse or use a protocol-recommended method of contraception from screening throughout study treatment and for 90 days after the last dose of ZE94-0605.
- Male participants of reproductive potential who have intercourse with females of childbearing potential must be willing to abstain from heterosexual intercourse or use a protocol-recommended method of contraception from the start of study treatment throughout study treatment and for 90 days after the last dose of ZE94-0605. Male participants must also refrain from sperm donation during this period.
- Willingness to comply with scheduled visits, the drug-administration plan, imaging studies, laboratory tests, other study procedures, and study restrictions.
Who cannot join
- History of another malignancy, except 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 another cancer that has been in complete remission without treatment for at least 2 years before enrollment or has a life expectancy of 24 months and does not require therapy that would confound interpretation of this study. Such cases must be discussed with the Medical Monitor before screening.
- Known active hepatitis C, hepatitis B, or human immunodeficiency virus infection.
- Pregnancy or breastfeeding.
- Concurrent participation in an investigational-drug trial with therapeutic intent, defined as receipt of prior study therapy within 14 days before study treatment.
- Inability to tolerate oral medication, including symptomatic disease that significantly affects gastrointestinal function, such as inflammatory bowel disease or resection of the stomach or small bowel.
- Receipt of an investigational agent for any indication within 5 half-lives of the agent. If the half-life is unknown, the participant must wait 1 week before the first dose of study treatment. An investigational agent is one for which there is no approved indication from the U.S. Food and Drug Administration.
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- Psychological, familial, social, or geographic factors; another significant medical condition; or a laboratory abnormality that precludes informed consent or protocol compliance, may hamper adherence to study treatment or follow-up, or would confound interpretation of study results.
- Uncontrolled intercurrent illness, including but not limited to symptomatic congestive heart failure, unstable angina pectoris, serious cardiac arrhythmia, New York Heart Association Class III or IV heart failure, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction-system abnormalities. Participants with medical comorbidities that would preclude safety evaluation of ZE94-0605 must not be enrolled.
- QT interval corrected using Fridericia's formula (QTcF) greater than or equal to 470 milliseconds, unless the participant has a pacemaker. Participants with an incomplete or complete right or left bundle branch block may participate if cleared for enrollment by a cardiology evaluation.
Trial locations and contacts
3 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
3 sites in 2 countries
Australia2 sites, 2 recruiting
- Recruiting
SOCRU - Southern Oncology Clinical Research Unit
Bedford Park, South Australia, 5042
Ashlee Hearnden, +61 491 679 039, ashlee.hearnden@socru.org.au
- Recruiting
St. George Private hospital
Kogarah, New South Wales, 2217
Meet Desai, +61285945785, clinicaltrials.sgp@ramsayhealth.com.au
Uzbekistan1 site, 1 recruiting
- Recruiting
Republican Specialized Scientific and Practical Medical Center of Oncology and Radiology Uzbekistan
Tashkent, 100109
Dilshod Rafiev, +998888926569, dilshod.rafiev@cancercenter.uz
About this study
Official title: A Phase 1, First-in-Human Study of ZE94-0605 in Patients With Advanced Solid Tumors
ZE94-0605 is an oral, selective cyclin-dependent kinase 2 (CDK2) inhibitor. This multicenter, open-label, first-in-human Phase 1 study will evaluate ZE94-0605 in adults with advanced, unresectable or metastatic solid tumors. Phase 1a will use sequential dose escalation to determine the maximally tolerated dose and biologically effective dose. Phase 1b will randomize participants with CCNE1 amplification, or another prospectively specified molecular feature, between two dose levels to select the recommended Phase 2 dose.
Read the detailed description
This is a multicenter, open-label, first-in-human Phase 1 study of oral ZE94-0605 in adults with pathologically confirmed advanced, unresectable or metastatic solid tumors that are refractory to, or intolerant of, available therapies known to provide clinical benefit, if available. ZE94-0605 is a selective inhibitor of cyclin-dependent kinase 2 (CDK2).
Phase 1a is a sequential dose-escalation portion using a standard 3+3 design. The planned once-daily dose levels are 100 mg, 200 mg, 350 mg, 500 mg, and 650 mg; an optional 50 mg dose level may be evaluated if 100 mg is not tolerated. Additional approximately 33% dose increments may be explored after 650 mg if a maximally tolerated dose or biologically effective dose has not been identified. Dose-limiting toxicities are evaluated during Cycle 1, which is 28 days.
After dose escalation, Phase 1b will randomize approximately 30 participants with CCNE1 amplification, or another prospectively specified molecular or cellular feature, between two expansion doses: the maximally tolerated dose and one dose level below it. Approximately 15 participants will be assigned to each dose. The recommended Phase 2 dose will be selected based on integrated safety, tolerability, pharmacokinetic, pharmacodynamic, and preliminary clinical-activity data.
ZE94-0605 is administered orally once daily in the fasted state in continuous 28-day cycles. Treatment may continue until disease progression, unacceptable toxicity, withdrawal, or completion of 26 cycles. Response assessments are scheduled before dosing on Day 1 of Cycles 3, 5, 7, 10, 13, 19, and 26. Pharmacokinetic and serum thymidine kinase 1 assessments are performed intensively during Cycles 1 and 2. Plasma circulating tumor DNA is assessed during Cycles 1, 2, 3, and 6, at scheduled response assessments, and at end of treatment, relapse, or progression.
- Being tested
- ZE94-0605
- Keywords
- ZE94-0605, Selective CDK2 inhibitor, CCNE1 amplification, Cyclin E1, First-in-human, Dose escalation, Dose optimization, Recommended Phase 2 dose, Project Optimus, Brain-penetrant CDK2 inhibitor
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZE94-0605Drug
Oral capsules QD
| Study group | Role | What they receive |
|---|---|---|
| Phase 1a Dose Level -1: ZE94-0605 50 mg QD | Experimental | Optional dose-reduction cohort. Participants will receive ZE94-0605 50 mg orally once daily in the fasted state in continuous 28-day cycles. This dose level will be evaluated only if Dose Level 1 is not tolerated. Receives: Drug: ZE94-0605 |
| Phase 1a Dose Level 1: ZE94-0605 100 mg QD | Experimental | Participants will receive ZE94-0605 100 mg orally once daily in the fasted state in continuous 28-day cycles. Receives: Drug: ZE94-0605 |
| Phase 1a Dose Level 2: ZE94-0605 200 mg QD | Experimental | Participants will receive ZE94-0605 200 mg orally once daily in the fasted state in continuous 28-day cycles. Receives: Drug: ZE94-0605 |
| Phase 1a Dose Level 3: ZE94-0605 350 mg QD | Experimental | Participants will receive ZE94-0605 350 mg orally once daily in the fasted state in continuous 28-day cycles. Receives: Drug: ZE94-0605 |
| Phase 1a Dose Level 4: ZE94-0605 500 mg QD | Experimental | Participants will receive ZE94-0605 500 mg orally once daily in the fasted state in continuous 28-day cycles. Receives: Drug: ZE94-0605 |
| Phase 1a Dose Level 5: ZE94-0605 650 mg QD | Experimental | Participants will receive ZE94-0605 650 mg orally once daily in the fasted state in continuous 28-day cycles. If the maximally tolerated dose or biologically effective dose has not been identified, subsequent dose levels may increase by approximately 33% following Safety Review Committee review. Receives: Drug: ZE94-0605 |
| Phase 1b Expansion Dose A: ZE94-0605 at the MTD | Experimental | Approximately 15 participants with CCNE1 amplification, or another prospectively specified molecular or cellular feature, will be randomized to receive ZE94-0605 orally once daily at the maximally tolerated dose in the fasted state in continuous 28-day cycles. Receives: Drug: ZE94-0605 |
| Phase 1b Expansion Dose B: ZE94-0605 One Dose Level Below the MTD | Experimental | Approximately 15 participants with CCNE1 amplification, or another prospectively specified molecular or cellular feature, will be randomized to receive ZE94-0605 orally once daily at one dose level below the maximally tolerated dose in the fasted state in continuous 28-day cycles. Receives: Drug: ZE94-0605 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Dose-Limiting Toxicities
Number and percentage of participants in Phase 1a who experience a protocol-defined dose-limiting toxicity. Dose-limiting toxicities are specified hematologic or non-hematologic toxicities graded using National Cancer Institute Common Terminology Criteria for Adverse Events, Version 6.0, that are not primarily attributable to the underlying cancer, a known disease complication, or a comorbid condition.
Measured: Cycle 1, Day 1 through Day 28
Maximally Tolerated Dose of ZE94-0605
The maximally tolerated dose is the highest evaluated dose at which no more than 1 of up to 6 participants experiences a dose-limiting toxicity during Cycle 1. Dose-exposure saturation and evidence of an efficacious dose with an acceptable safety margin may also inform termination of dose escalation.
Measured: Through completion of the Phase 1a dose-escalation portion, estimated up to approximately 24 months
Recommended Phase 2 Dose of ZE94-0605
The recommended Phase 2 dose will be selected following randomized evaluation of two Phase 1b expansion doses based on integrated safety, tolerability, pharmacokinetic, pharmacodynamic, and preliminary clinical-activity data.
Measured: Through completion of the Phase 1b dose-expansion portion, estimated up to approximately 24 months
Secondary outcomes (9)
Number of Participants With Treatment-Emergent Adverse Events
Number and percentage of participants with treatment-emergent adverse events, serious adverse events, and adverse events leading to dose modification, treatment discontinuation, or death. Severity will be graded using National Cancer Institute Common Terminology Criteria for Adverse Events, Version 6.0.
Measured: From first dose through 30 days after the last dose of ZE94-0605
Overall Response Rate
The proportion of evaluable participants whose best overall response is complete response or partial response, assessed using Response Evaluation Criteria in Solid Tumors, Version 1.1, or other disease-appropriate response criteria specified for the participant. Results will be summarized by tumor type and CCNE1 amplification status.
Measured: From baseline through Cycle 26 or end of treatment, up to approximately 24 months
Duration of Response
Among participants with a complete or partial response, duration of response is the time from the first documented response until documented disease progression or death from any cause, whichever occurs first. Results will be summarized by CCNE1 amplification status.
Measured: From first documented response through study completion, up to approximately 24 months
Overall Survival
Overall survival is the time from the first dose of ZE94-0605 until death from any cause.
Measured: From first dose through long-term follow-up and study completion, up to approximately 24 months
Maximum Observed Plasma Concentration of ZE94-0605
Maximum observed plasma concentration (Cmax) of ZE94-0605 derived from serial plasma pharmacokinetic samples.
Measured: Cycle 1 Day 1 through Cycle 2 Day 2; each cycle is 28 days
Area Under the Plasma Concentration-Time Curve of ZE94-0605
Area under the plasma concentration-time curve (AUC) of ZE94-0605 derived from serial plasma pharmacokinetic samples.
Measured: Cycle 1 Day 1 through Cycle 2 Day 2; each cycle is 28 days
Time to Maximum Observed Plasma Concentration of ZE94-0605
Time to maximum observed plasma concentration (Tmax) of ZE94-0605 derived from serial plasma pharmacokinetic samples.
Measured: Cycle 1 Day 1 through Cycle 2 Day 2; each cycle is 28 days
Terminal Elimination Half-Life of ZE94-0605
Apparent terminal elimination half-life of ZE94-0605 derived from serial plasma pharmacokinetic samples.
Measured: Cycle 1 Day 1 through Cycle 2 Day 2; each cycle is 28 days
Change From Baseline in Serum Thymidine Kinase 1
Serum thymidine kinase 1 concentrations and change from baseline will be evaluated as a pharmacodynamic marker of ZE94-0605 activity.
Measured: Cycle 1 Day 1 through Cycle 2 Day 2, including additional predose assessments on Cycle 1 Days 8 and 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start25 Jun 2026
- Primary completionJan 2028 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid Tumor CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Phase 1a uses sequential 3+3 dose escalation. After completion of dose escalation and selection of the maximally tolerated dose, Phase 1b uses parallel randomized assignment to two expansion doses: the maximally tolerated dose and one dose level below it.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eilean Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07524140
- Sponsor's protocol ID
- ZE94-0605-0001
- Status last verified
- Jul 2026
- First submitted
- 27 Mar 2026
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, First-in-Human Study of ZE94-0605 in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT07524140
- Acronym / sponsor ID
- ZE94-0605-0001
- Keywords
- ZE94-0605, Selective CDK2 inhibitor, CCNE1 amplification, Cyclin E1, First-in-human, Dose escalation, Dose optimization, Recommended Phase 2 dose
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Eilean TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 25 Jun 2026 (actual)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 13 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
ZE94-0605 is an oral, selective cyclin-dependent kinase 2 (CDK2) inhibitor. This multicenter, open-label, first-in-human Phase 1 study will evaluate ZE94-0605 in adults with advanced, unresectable or metastatic solid tumors. Phase 1a will use sequential dose escalation to determine the maximally tolerated dose and biologically effective dose. Phase 1b will randomize participants with CCNE1 amplification, or another prospectively specified molecular feature, between two dose levels to select the recommended Phase 2 dose.
Detailed description
This is a multicenter, open-label, first-in-human Phase 1 study of oral ZE94-0605 in adults with pathologically confirmed advanced, unresectable or metastatic solid tumors that are refractory to, or intolerant of, available therapies known to provide clinical benefit, if available. ZE94-0605 is a selective inhibitor of cyclin-dependent kinase 2 (CDK2).
Phase 1a is a sequential dose-escalation portion using a standard 3+3 design. The planned once-daily dose levels are 100 mg, 200 mg, 350 mg, 500 mg, and 650 mg; an optional 50 mg dose level may be evaluated if 100 mg is not tolerated. Additional approximately 33% dose increments may be explored after 650 mg if a maximally tolerated dose or biologically effective dose has not been identified. Dose-limiting toxicities are evaluated during Cycle 1, which is 28 days.
After dose escalation, Phase 1b will randomize approximately 30 participants with CCNE1 amplification, or another prospectively specified molecular or cellular feature, between two expansion doses: the maximally tolerated dose and one dose level below it. Approximately 15 participants will be assigned to each dose. The recommended Phase 2 dose will be selected based on integrated safety, tolerability, pharmacokinetic, pharmacodynamic, and preliminary clinical-activity data.
ZE94-0605 is administered orally once daily in the fasted state in continuous 28-day cycles. Treatment may continue until disease progression, unacceptable toxicity, withdrawal, or completion of 26 cycles. Response assessments are scheduled before dosing on Day 1 of Cycles 3, 5, 7, 10, 13, 19, and 26. Pharmacokinetic and serum thymidine kinase 1 assessments are performed intensively during Cycles 1 and 2. Plasma circulating tumor DNA is assessed during Cycles 1, 2, 3, and 6, at scheduled response assessments, and at end of treatment, relapse, or progression.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 8
- Model description
- Phase 1a uses sequential 3+3 dose escalation. After completion of dose escalation and selection of the maximally tolerated dose, Phase 1b uses parallel randomized assignment to two expansion doses: the maximally tolerated dose and one dose level below it.
| Arm | Type | Receives |
|---|---|---|
| Phase 1a Dose Level -1: ZE94-0605 50 mg QD | Experimental | Drug: ZE94-0605Optional dose-reduction cohort. Participants will receive ZE94-0605 50 mg orally once daily in the fasted state in continuous 28-day cycles. This dose level will be evaluated only if Dose Level 1 is not tolerated. |
| Phase 1a Dose Level 1: ZE94-0605 100 mg QD | Experimental | Drug: ZE94-0605Participants will receive ZE94-0605 100 mg orally once daily in the fasted state in continuous 28-day cycles. |
| Phase 1a Dose Level 2: ZE94-0605 200 mg QD | Experimental | Drug: ZE94-0605Participants will receive ZE94-0605 200 mg orally once daily in the fasted state in continuous 28-day cycles. |
| Phase 1a Dose Level 3: ZE94-0605 350 mg QD | Experimental | Drug: ZE94-0605Participants will receive ZE94-0605 350 mg orally once daily in the fasted state in continuous 28-day cycles. |
| Phase 1a Dose Level 4: ZE94-0605 500 mg QD | Experimental | Drug: ZE94-0605Participants will receive ZE94-0605 500 mg orally once daily in the fasted state in continuous 28-day cycles. |
| Phase 1a Dose Level 5: ZE94-0605 650 mg QD | Experimental | Drug: ZE94-0605Participants will receive ZE94-0605 650 mg orally once daily in the fasted state in continuous 28-day cycles. If the maximally tolerated dose or biologically effective dose has not been identified, subsequent dose levels may increase by approximately 33% following Safety Review Committee review. |
| Phase 1b Expansion Dose A: ZE94-0605 at the MTD | Experimental | Drug: ZE94-0605Approximately 15 participants with CCNE1 amplification, or another prospectively specified molecular or cellular feature, will be randomized to receive ZE94-0605 orally once daily at the maximally tolerated dose in the fasted state in continuous 28-day cycles. |
| Phase 1b Expansion Dose B: ZE94-0605 One Dose Level Below the MTD | Experimental | Drug: ZE94-0605Approximately 15 participants with CCNE1 amplification, or another prospectively specified molecular or cellular feature, will be randomized to receive ZE94-0605 orally once daily at one dose level below the maximally tolerated dose in the fasted state in continuous 28-day cycles. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age 18 years or older with a pathologically confirmed, advanced, unresectable or metastatic solid tumor that is refractory to, or intolerant of, available existing therapy or therapies known to provide clinical benefit for the condition, if available, and with measurable disease.
- Age 18 years or older with a pathologically confirmed, advanced, unresectable or metastatic solid tumor that is refractory to, or intolerant of, available existing therapy or therapies known to provide clinical benefit for the condition, if available, or who has declined such therapy; presence of CCNE1 amplification; and measurable disease.
- Eastern Cooperative Oncology Group performance status of 0 or 1.
- Adequate end-organ function, defined as creatinine clearance greater than 60 mL/min, aspartate aminotransferase and alanine aminotransferase less than 3 times the upper limit of normal, and total bilirubin less than 1.5 times the upper limit of normal, except for participants with Gilbert's disease.
- Absolute neutrophil count at least 1.5 × 10^9/L and platelet count at least 100 × 10^9/L.
Key exclusion criteria (9 listed)
- History of another malignancy, except 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 another cancer that has been in complete remission without treatment for at least 2 years before enrollment or has a life expectancy of 24 months and does not require therapy that would confound interpretation of this study. Such cases must be discussed with the Medical Monitor before screening.
- Known active hepatitis C, hepatitis B, or human immunodeficiency virus infection.
- Pregnancy or breastfeeding.
- Concurrent participation in an investigational-drug trial with therapeutic intent, defined as receipt of prior study therapy within 14 days before study treatment.
- Inability to tolerate oral medication, including symptomatic disease that significantly affects gastrointestinal function, such as inflammatory bowel disease or resection of the stomach or small bowel.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZE94-0605Oral capsules QD | Drug | Phase 1a Dose Level -1: ZE94-0605 50 mg QD, Phase 1a Dose Level 1: ZE94-0605 100 mg QD, Phase 1a Dose Level 2: ZE94-0605 200 mg QD, Phase 1a Dose Level 3: ZE94-0605 350 mg QD, Phase 1a Dose Level 4: ZE94-0605 500 mg QD, Phase 1a Dose Level 5: ZE94-0605 650 mg QD, Phase 1b Expansion Dose A: ZE94-0605 at the MTD, Phase 1b Expansion Dose B: ZE94-0605 One Dose Level Below the MTD |
Primary outcome
Number of Participants With Dose-Limiting Toxicities
Time frame: Cycle 1, Day 1 through Day 28
Number and percentage of participants in Phase 1a who experience a protocol-defined dose-limiting toxicity. Dose-limiting toxicities are specified hematologic or non-hematologic toxicities graded using National Cancer Institute Common Terminology Criteria for Adverse Events, Version 6.0, that are not primarily attributable to the underlying cancer, a known disease complication, or a comorbid condition.
Maximally Tolerated Dose of ZE94-0605
Time frame: Through completion of the Phase 1a dose-escalation portion, estimated up to approximately 24 months
The maximally tolerated dose is the highest evaluated dose at which no more than 1 of up to 6 participants experiences a dose-limiting toxicity during Cycle 1. Dose-exposure saturation and evidence of an efficacious dose with an acceptable safety margin may also inform termination of dose escalation.
Recommended Phase 2 Dose of ZE94-0605
Time frame: Through completion of the Phase 1b dose-expansion portion, estimated up to approximately 24 months
The recommended Phase 2 dose will be selected following randomized evaluation of two Phase 1b expansion doses based on integrated safety, tolerability, pharmacokinetic, pharmacodynamic, and preliminary clinical-activity data.
9 secondary outcomes
Number of Participants With Treatment-Emergent Adverse Events
Time frame: From first dose through 30 days after the last dose of ZE94-0605
Overall Response Rate
Time frame: From baseline through Cycle 26 or end of treatment, up to approximately 24 months
Duration of Response
Time frame: From first documented response through study completion, up to approximately 24 months
Overall Survival
Time frame: From first dose through long-term follow-up and study completion, up to approximately 24 months
Maximum Observed Plasma Concentration of ZE94-0605
Time frame: Cycle 1 Day 1 through Cycle 2 Day 2; each cycle is 28 days
Area Under the Plasma Concentration-Time Curve of ZE94-0605
Time frame: Cycle 1 Day 1 through Cycle 2 Day 2; each cycle is 28 days
Time to Maximum Observed Plasma Concentration of ZE94-0605
Time frame: Cycle 1 Day 1 through Cycle 2 Day 2; each cycle is 28 days
Terminal Elimination Half-Life of ZE94-0605
Time frame: Cycle 1 Day 1 through Cycle 2 Day 2; each cycle is 28 days
Change From Baseline in Serum Thymidine Kinase 1
Time frame: Cycle 1 Day 1 through Cycle 2 Day 2, including additional predose assessments on Cycle 1 Days 8 and 15
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ZE94-0605 in people with Advanced Solid Tumor Cancer and Metastatic Solid Tumor, run by Eilean Therapeutics at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Australia, Uzbekistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ekaterina Dokukina (+1 858 353 4108, kdokukina@eilenther.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Dose-Limiting Toxicities (time frame: Cycle 1, Day 1 through Day 28). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2026.