Testing DAY301 for advanced or metastatic solid tumors
Official title: To Evaluate the Safety, Tolerability, Pharmacokinetics and Antitumor Activity of DAY301 in Participants With Locally Advanced or Metastatic Solid Tumors
A Phase 1, Open Label, Multiple Dose, Dose Escalation and Expansion Study to Investigate the Safety, Tolerability, Pharmacokinetics and Antitumor Activity of the PTK7-Targeted Antibody-drug Conjugate DAY301 in Patients With Locally Advanced or Metastatic Solid Tumors
- Phase 1
- 1 group
- Sites in Vancouver and Toronto
- Recruiting
Interventions
- Medication
DAY301
DAY301 will be administered as IV infusion
Canadian Sites (2)
2 of 2 recruiting
- Recruiting
Site: 011-013
Vancouver, British Columbia
- Recruiting
Site: 011-005
Toronto, Ontario
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
- +Histologically or cytologically confirmed diagnosis of advanced or metastatic solid tumors of the following histologies:
- +Ovarian cancer
- +Esophageal squamous cell carcinoma
- +Triple-negative breast cancer
- +Non-small cell lung cancer
- +Small cell lung cancer
- +Head and neck squamous cell carcinoma
- +Cervical squamous cell carcinoma
- +Endometrial cancers
- +(Participants must have been previously treated with standard of careStandard of careThe treatment normally given for a condition outside a study.Read more → systemic therapy, have refused standard therapy, or have no standard therapy available).
- +Availability of tumor tissue sample (either an archival specimen or a fresh biopsy) at screeningScreeningThe checks done before joining, to see whether a study fits.Read more →
- +Measurable disease per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1).
- +Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- +Adequate organ function.
Exclusion
- −Active or progressing brain metastases or evidence of leptomeningeal disease.
- −Prior use of PTK7 targeting treatment (Phase 1a) or prior use of PTK7 targeting treatments and/or topoisomerase 1 (TOP1) inhibitors (Phase 1b).
- −Phase 1b disease-specific exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more →:
- −CohortCohortA group of participants sharing a characteristic, followed together.Read more → 1: Neuroendocrine tumors or endometrial sarcoma (eg, stromal sarcoma, leiomyosarcoma, or other types of pure sarcomas)
- −Cohort 2: Nasopharyngeal primary tumors.
- −Ascites requiring frequent paracentesis (more often than approximately every 4 weeks) for symptomatic management, or new onset within 4 weeks prior to the first dose of study treatment. Patients with an indwelling catheter may be considered eligible, after consultation with the medical monitor.
- −Persistent toxicities from previous systemic antineoplastic treatments of Grade \>1, excluding alopecia and vitiligo.
- −Systemic antineoplastic therapy within five half-lives or 4 weeks, whichever is shorter, prior to first dose of study treatment, including investigational agents.
- −Note: Other protocolProtocolThe detailed plan a study must follow.Read more → defined InclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more →/Exclusion criteria may apply.
- −Cohort 3: Ovarian cancer that progressed \>6 months after the last dose of platinum-based chemotherapy (platinum-sensitive disease), or disease that did not respond (PR or complete response \[CR\]) to or progressed ≤91 days after the last dose of first-line platinum-based chemotherapy (primary platinum-refractory disease) .- History of small bowel obstruction requiring hospitalization within 3 months prior to the first dose of study treatment.
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
Everyone in this study is in one group and receives DAY301.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
There is only one group in this study, so there is no assignment to different treatments.
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 18 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 300 people.
The study is currently expected to finish around December 2028.
The main measurement is taken over: Within 21 days of first infusion (Day 1).
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Phase 1a: Dose EscalationDose escalationLater groups receive higher amounts than earlier ones, increased step by step.Read more →: Number of participants with reported Dose Limiting Toxicities (DLTs) — measured over Within 21 days of first infusion (Day 1).
Phase 1a: Dose Escalation: Number of participants with reported adverse eventsAdverse eventAny medical problem that happens during a study, whether or not the treatment caused it.Read more → (AEs) and serious AEs (SAEs) — measured over through the duration of treatment, up to approximately 12 months.
Phase 1a: Dose Escalation: Frequency of dose interruptions — measured over through the duration of treatment, up to approximately 12 months.
Phase 1a: Dose Escalation: Duration of dose interruptions — measured over through the duration of treatment, up to approximately 12 months.
The study lists 8 further main measurements.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT06752681 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 DAY301Drug
DAY301 will be administered as IV infusion
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 18 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.
There is only one group in this study, so there is no assignment to different treatments.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 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: Within 21 days of first infusion (Day 1).
The study as a whole is currently expected to finish around 2028-12.
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 300 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 4 locations, including: Vancouver, British Columbia, Canada; Toronto, Ontario, Canada; Grand Rapids, Michigan, 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
This is a Phase 1a/1b, open-label, dose escalation and expansion study to evaluate the safety and anti-tumor activity of DAY301, a PTK7-directed antibody-drug conjugate (ADC) in participants with advanced or metastatic solid tumors. The study comprises of 2 phases: Phase 1a dose escalation where participants will be administered DAY301 at escalating dose levels to assess safety and tolerability, and to determine the maximum tolerated dose (MTD) and/or the recommended dose (RD); In Phase 1b dose expansion, DAY301 will be evaluated in dose expansion cohorts.
Other Sites (2)
Site: 001-059
Grand Rapids, Michigan, United States
Site: 001-039
New York, New York, United States
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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.