Comparing 3 approaches for advanced solid tumor
Official title: Study of Lunresertib Alone or in Combination With RP-3500 or Debio 0123 in Patients With Advanced Solid Tumors
Phase 1/1b Study of the Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Clinical Activity of Lunresertib Alone or in Combination With RP-3500 or Debio 0123 in Patients With Advanced Solid Tumors
- Phase 1
- 3 groups
- Sites in Toronto and Montreal
- Recruiting
Interventions
- Medication
Lunresertib
Oral PKMYT1 Inhibitor
- Medication
RP-3500
Oral ATR Inhibitor
- Medication
Debio0123
Oral WEE1 Inhibitor
Canadian Sites (3)
1 of 3 recruiting
- Recruiting
#2001, Princess Margaret Cancer Centre
Toronto, Ontario
- Completed
#2002, The Hospital for Sick Children
Toronto, Ontario
- Completed
#2003, The Research Institute of the McGill University Health Centre
Montreal, Quebec
Eligibility Criteria
See who this study is looking for24 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Male or female and ≥12 years-of-age at the time of informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more →.
- +Lansky performance status ≥50% for patients ≤16 years of age, or ECOG score of 0, 1, (or 2 for module 1) for patients \>16 years of age.
- +Locally advanced or metastatic resistant or refractory solid tumors.
- +Patients \<18 years of age must weigh at least 40 kg.
- +Submission of available tumor tissue at screeningScreeningThe checks done before joining, to see whether a study fits.Read more → or willingness to have a biopsy performed if safe and feasible
- +Next generation sequencing (NGS) report obtained in a CLIA-certified or equivalent laboratory demonstrating eligible tumor biomarkerBiomarkerSomething measurable in the body used as a signal of what is happening.Read more →.
- +CCNE1 amplification (non-equivocal) as determined by either a tumor or plasma NGS test, or FISH
- +FBXW7 deleterious mutations identified by either a tumor or plasma NGS test
- +PPP2R1A deleterious mutations identified by either a tumor or plasma NGS test
- +Measurable disease as per RECIST v1.1. For certain modules, patients with prostate cancer or ovarian cancer that have non-measurable disease but have elevated tumor markers (PSA or CA-125, respectively) can also be eligible
- +Ability to swallow and retain oral medications.
- +Acceptable hematologic and organ function at screening.
- +Resolution of all toxicities of prior therapy or surgical procedures.
- +Negative pregnancy test (serum) for women of childbearing potential (WOCBP) at Screening.
- +Any prior radiation must have been completed at least 7 days prior to the start of study drugs, and patients must have recovered from any acute adverse effects prior to the start of study treatment.
Exclusion
- −Uncontrolled, symptomatic brain metastases.
- −History or current condition, therapy, or laboratory abnormality that might confound the study results or interfere with the patient's participation for the full duration of the study treatment.
- −Life-threatening illness, medical condition, active uncontrolled infection, or organ system dysfunction or other reasons which, in the investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →'s opinion, could compromise the participating patient's safety.
- −Uncontrolled hypertension.
- −Certain prior anti-cancer therapy
- −Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocolProtocolThe detailed plan a study must follow.Read more → and/or follow-upFollow-upContinued check-ins after the treatment part is finished.Read more → procedures outlined in the protocol.
- −Patients who are pregnant or breastfeeding.
- −Chemotherapy or small molecule antineoplastic agent given within 21 days or \<5 half-lives, whichever is shorter, prior to first dose of study drug.
- −Major surgery within 4 weeks prior to first dose of lunresertib.
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 1Phase 1The earliest stage of human testing, in a small group, focused on safety.Read more → — an early safety study in a small group, checking how it is tolerated and at what dose.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 3 groups in this study.
Group A receives Lunresertib.
Registry label: A: Phase 1: Lunresertib Single-Agent, Dose Escalation and Food-effect Study
Group B receives Lunresertib and RP-3500.
Registry label: B: Phase 1: Lunresertib in combination with RP-3500, Dose Escalation Study
Group C receives Lunresertib, together with one or more of: Debio0123.
Registry label: C: Phase 1: Lunresertib in combination with Debio 0123, Dose Escalation Study
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Groups are assigned by the study team using set rules, rather than by chance.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists a minimum age of 12 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 464 people.
The study is currently expected to finish around June 2028.
The main measurement is taken over: Up to 90 days after last administration of study intervention.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Safety and Tolerability of lunresertib either in monotherapy or in combination with RP-3500 or with Debio 0123 in patients with eligible advanced solid tumors — measured over Up to 90 days after last administration of study intervention.
To define the MTDMaximum tolerated doseThe highest amount that can be given before side effects become unacceptable.Read more → of lunresertib monotherapy, and determine a recommended Phase 2Phase 2A middle-stage study looking at what a treatment does and watching for side effects.Read more → dose (RP2D) and preferred schedule — measured over Up to 90 days after last administration of study intervention.
To define the MTD of lunresertib in combination with RP-3500 or in combination with Debio 0123, and determine a recommended Phase 2 dose (RP2D) and preferred schedule — measured over Up to 90 days after last administration of study intervention.
The relative bioavailability of lunresertib capsule formulation as compared to lunresertib tablet formulation in the fasted state — measured over Time 0 (time of dosing) to 72 hours post-dose for each treatment condition.
The study lists 2 further main measurements.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT04855656 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About LunresertibDrug
Oral PKMYT1 Inhibitor
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About RP-3500Drug
Oral ATR Inhibitor
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About Debio0123Drug
Oral WEE1 Inhibitor
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 12 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
Groups are assigned by the study team using set rules, rather than by chance.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 12 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: Up to 90 days after last administration of study intervention.
The study as a whole is currently expected to finish around 2028-06.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 464 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 6 locations, including: Toronto, Ontario, Canada; Montreal, Quebec, Canada; Grand Rapids, Michigan, United States; Rochester, Minnesota, United States; New Hyde Park, New York, United States; New York, New York, United States.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
The primary purpose of this study is to assess the safety and tolerability of lunresertib alone and in combination with RP-3500 or in combination with Debio 0123 in patients with eligible advanced solid tumors, determine the maximum tolerated dose (MTD) and assess preliminary anti-tumor activity.
Other Sites (5)
#1023, START Midwest
Grand Rapids, Michigan, United States
#1016, Mayo Clinic
Rochester, Minnesota, United States
#1032, Northwell Health Cancer Institute
New Hyde Park, New York, United States
#1008, Columbia University
New York, New York, United States
#1004, Memorial Sloan Kettering Cancer Institute
New York, New York, United States
Think this trial might be right for you?
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.