A Phase 1 interventional study of ZE94-0605 in Advanced Solid Tumor Cancer and Metastatic Solid Tumor, sponsored by Eilean Therapeutics. Recruiting at 3 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-09.
Sponsored by Eilean Therapeutics · Phase 1, Interventional, and Treatment
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 between two dose levels to select the recommended Phase 2 dose.
This multicenter, open-label, first-in-human Phase 1 study evaluates oral ZE94-0605, a selective inhibitor of cyclin-dependent kinase 2 (CDK2), in adults with advanced, unresectable or metastatic solid tumors. The study comprises two sequential stages: Phase 1a dose escalation and Phase 1b randomized dose optimization/expansion.
Phase 1a uses a standard 3+3 design with planned oral once-daily dose levels of 100, 200, 350, 500, and 650 mg. An optional 50 mg dose level may be evaluated if the 100 mg dose is not tolerated. Additional or intermediate doses may be considered after Safety Review Committee review. Dose-limiting toxicities (DLTs) are evaluated during Cycle 1 (28 days). Dose escalation may stop on identification of the maximally tolerated dose (MTD), dose-exposure saturation, or an effective dose with an acceptable safety margin.
In Phase 1b, approximately 30 participants with CCNE1-amplified advanced solid tumors will be randomized 1:1 to two ZE94-0605 doses selected from Phase 1a, anticipated to be the MTD or biologically effective dose and one dose level below it. Selection of the recommended Phase 2 dose will integrate 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 for up to 26 cycles unless earlier discontinuation criteria are met. Responses will be assessed within ±7 days of the scheduled Day 1 of Cycles 3, 5, 7, 10, 13, 19, and 26. Responses for solid tumors are assessed by central RECIST 1.1 review and confirmed by the Sponsor Medical Monitor; glioblastoma is assessed using RANO 2.0 with central review and Medical Monitor confirmation. Disease-appropriate CT and/or MRI is used, including protocol-specified brain MRI for glioblastoma or known/suspected brain metastases.
Safety assessments include adverse events, laboratory testing, vital signs, physical examinations, and electrocardiograms. Serial plasma pharmacokinetic sampling, serum thymidine kinase 1, plasma circulating tumor DNA, and tumor tissue assessments will be performed as specified in the protocol. Tissue confirming the required molecular marker(s) is mandatory for Phase 1b, whereas tissue collection in Phase 1a is optional when available and consented.
Participants undergo a 30-day safety follow-up following the last dose. Thereafter, survival, relapse, and other outcomes are assessed every 3 months (±14 days) until 1 year after the last dose or study completion, whichever occurs first, unless consent for follow-up is withdrawn.
4,040 studies on the registry are indexed under Neoplasm Metastasis; 886 are open to participants now.
This study's planned enrollment of 60 is above the median of 50 across 3,268 interventional studies indexed under Neoplasm Metastasis.
Browse Neoplasm Metastasis studies →Eilean Therapeutics is the lead sponsor of 5 studies on the registry; 3 are open to participants now.
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The criteria were revised on the registry on Nov 9, 2026. See what changed
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Phase 1a Dose-Escalation Cohorts:
Age ≥18 years, with a confirmed, advanced, unresectable or solid tumor to, or intolerant of, available therapies known to provide clinical benefit for the participant's condition, if available, and with .
Phase 1b Dose-Expansion Cohorts:
Age ≥18 years, with a pathologically confirmed, advanced, unresectable or metastatic solid tumor refractory to, or intolerant of, available therapies known to provide clinical benefit for the participant's condition, if available, or who has declined such therapy, with CCNE1 amplification and measurable disease.
Common Inclusion Criteria:
Exclusion Criteria
Note: This text is faithfully condensed for a public registry; original criterion numbering differs. The protocol places the newly prohibited medication reconciliation instruction at the end of exclusion criterion 9; keep this in investigator instructions rather than individual eligibility criteria, unless preferred by sponsor.
Note: Especially material changes: window for women 90 days (older entry used 30 days); washout changed to longer of 14 days or 5 half-lives; PPI exclusion; newly explicit MRI/pacemaker safeguards.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Washout period
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CYP3A (CYP3A4) inhibitors and inducers
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: ZE94-0605
Participants will receive ZE94-0605 100 mg orally once daily in the fasted state in continuous 28-day cycles.
Drug: ZE94-0605
Participants will receive ZE94-0605 200 mg orally once daily in the fasted state in continuous 28-day cycles.
Drug: ZE94-0605
Participants will receive ZE94-0605 350 mg orally once daily in the fasted state in continuous 28-day cycles.
Drug: ZE94-0605
Participants will receive ZE94-0605 500 mg orally once daily in the fasted state in continuous 28-day cycles.
Drug: ZE94-0605
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.
Drug: ZE94-0605
Approximately 15 eligible participants with CCNE1 amplification are randomized to receive ZE94-0605 at the MTD or biologically effective dose selected from Phase 1a, orally once daily in the fasted state in continuous 28-day cycles.
Drug: ZE94-0605
Approximately 15 eligible participants with CCNE1 amplification are randomized to receive ZE94-0605 at one dose level below the MTD or biologically effective dose selected from Phase 1a, orally once daily in the fasted state in continuous 28-day cycles.
Drug: ZE94-0605
ZE94-0605 is an investigational, selective CDK2 inhibitor supplied as oral capsules in 50 mg and 100 mg strengths. It is administered once daily with approximately 240 mL water in a fasted state (no food for at least 2 hours before or 1 hour after dosing), in continuous 28-day cycles at the cohort-assigned dose. Capsules are swallowed whole.
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.
Time frame: 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.
Time frame: 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.
Time frame: Through completion of the Phase 1b dose-expansion portion, estimated up to approximately 24 months
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.
Time frame: From first dose through 30 days after the last dose of ZE94-0605
Overall Response Rate
Proportion of evaluable participants with a best overall response of complete or partial response, with response evaluated by central RECIST 1.1 review and Sponsor Medical Monitor confirmation for solid tumors and by central RANO 2.0 review and Sponsor Medical Monitor confirmation for glioblastoma. Response is summarized by tumor type and CCNE1 amplification status.
Time frame: From baseline through Cycle 26 or end of treatment, up to approximately 24 months
Duration of Response
For participants with a complete or partial response, duration from first documented response to disease progression or death from any cause. Response is assessed using RECIST 1.1 or RANO 2.0, as appropriate, with central review and Sponsor Medical Monitor confirmation. Results will be summarized by CCNE1 amplification status.
Time frame: From first documented response through disease progression, death, or study completion, up to approximately 24 months
Overall Survival
Time from the first dose of ZE94-0605 to death from any cause. Following the 30-day post-treatment follow-up, survival status is assessed every 3 months (±14 days) until 1 year after the last dose or study completion, whichever occurs first.
Time frame: From first dose through follow-up (up to 1 year after last dose or study completion, whichever occurs first)
Maximum Observed Plasma Concentration of ZE94-0605
Maximum observed plasma concentration (Cmax) of ZE94-0605 derived from serial plasma pharmacokinetic samples.
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
Area under the plasma concentration-time curve (AUC) of ZE94-0605 derived from serial plasma pharmacokinetic samples.
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 to maximum observed plasma concentration (Tmax) of ZE94-0605 derived from serial plasma pharmacokinetic samples.
Time frame: 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.
Time frame: Cycle 1 Day 1 through Cycle 2 Day 2; each cycle is 28 days
Change From Baseline in Serum Thymidine Kinase 1
Change from baseline in serum thymidine kinase 1 (TK1) concentration, measured as a pharmacodynamic marker of ZE94-0605 activity.
Time frame: Predose on Cycle 1 Days 1, 8, and 15; and Day 1 of Cycles 2, 3, and 6,
Change in Plasma Circulating Tumor DNA
Plasma circulating tumor DNA will be evaluated by research next-generation sequencing to assess molecular response dynamics and potential mechanisms of resistance.
Time frame: Predose on Day 1 of Cycles 1, 2, 3, and 6; at scheduled response assessments; and at end of treatment, relapse, or progression
Change From Baseline in Exploratory Biomarkers of CDK2 Inhibition
Alternative exploratory biomarkers of CDK2 pathway inhibition may be evaluated ex vivo using plasma samples to refine and validate surrogate measures of target activity.
Time frame: Cycle 1 Day 1 predose, 2 hours, 8 hours, and approximately 24 hours postdose
Association of Tumor Molecular Characteristics With Response or Resistance
Baseline and, where available, subsequent tissue molecular characteristics and plasma ctDNA may be analyzed using next-generation sequencing or other exploratory methods to investigate associations with response or resistance and potential companion-diagnostic development. Tissue for molecular eligibility confirmation is required for Phase 1b; Phase 1a tissue banking is optional.
Time frame: From baseline molecular characterization through disease progression or study completion, up to approximately 24 months
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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