Advanced or Metastatic Solid TumorsPhase 1NCT06752681
To Evaluate the Safety, Tolerability, Pharmacokinetics and Antitumor Activity of DAY301 in Participants With Locally Advanced or Metastatic Solid Tumors
A Phase 1 study testing DAY301 in people with Advanced or Metastatic Solid Tumors, run by Day One Biopharmaceuticals, Inc. at 11 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced or Metastatic Solid Tumors
- What is being tested?
- DAY301
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 11 sitesin 2 countries
- Study dates
- 18 Nov 2024to Dec 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
- 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
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- Head and neck squamous cell carcinoma
- Cervical squamous cell carcinoma
- Endometrial cancers
- (Participants must have been previously treated with standard of care 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 screening
- 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.
Who cannot join
- 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 criteria:
- Cohort 1: Neuroendocrine tumors or endometrial sarcoma (eg, stromal sarcoma, leiomyosarcoma, or other types of pure sarcomas)
- Cohort 2: Nasopharyngeal primary tumors.
- 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.
- 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.
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- Active or progressing brain metastases or evidence of leptomeningeal disease.
- 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 protocol defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
11 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
11 sites in 2 countries
United States9 sites, 9 recruiting
- Recruiting
Site: 001-060
Avon, Indiana, 46202
- Recruiting
Site: 001-059
Grand Rapids, Michigan, 49546
- Recruiting
Site: 001-069
Houston, Texas, 77030
- Recruiting
Site: 001-065
Nashville, Tennessee, 37203
- Recruiting
Site: 001-058
New Haven, Connecticut, 06511
- Recruiting
Site: 001-039
New York, New York, 10065
- Recruiting
Site: 001-073
Oklahoma City, Oklahoma, 73104
- Recruiting
Site: 001-057
San Antonio, Texas, 78240
- Recruiting
Site: 001-064
Sarasota, Florida, 34232
Canada2 sites, 2 recruiting
- Recruiting
Site: 011-005
Toronto, Ontario, M5G 2M9
- Recruiting
Site: 011-013
Vancouver, British Columbia, V5Z 4E6
About this study
Official title: 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
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.
- Conditions
- Advanced or Metastatic Solid Tumors
- Being tested
- DAY301
- Keywords
- Advanced or metastatic solid tumors, Dose Escalation, Dose Expansion, DAY301, PTK7-Targeted Antibody-drug Conjugate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DAY301Drug
DAY301 will be administered as IV infusion
| Study group | Role | What they receive |
|---|---|---|
| DAY301 intravenous (IV) infusion | Experimental | DAY301 will be administered at different dose levels in dose escalation and at the RD in dose expansion cohorts. Receives: Drug: DAY301 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1a: Dose Escalation: Number of participants with reported Dose Limiting Toxicities (DLTs)
To evaluate adverse events (AEs) considered dose limiting toxicities that occur in the first cycle of treatment (within a DLT observation period).
Measured: Within 21 days of first infusion (Day 1)
Phase 1a: Dose Escalation: Number of participants with reported adverse events (AEs) and serious AEs (SAEs)
The type, incidence, and severity of AEs and SAEs will be determined using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Measured: through the duration of treatment, up to approximately 12 months
Phase 1a: Dose Escalation: Frequency of dose interruptions
The frequency at which dose interruptions occur during dose-escalation
Measured: through the duration of treatment, up to approximately 12 months
Phase 1a: Dose Escalation: Duration of dose interruptions
The duration of dose interruptions that occur during dose-escalation.
Measured: through the duration of treatment, up to approximately 12 months
Phase 1a: Dose Escalation: Frequency of dose reductions
The frequency at which dose reductions occur during dose-escalation.
Measured: through the duration of treatment, up to approximately 12 months
Phase 1a: Dose Escalation: Duration of dose reductions
The duration of dose reductions that occur during dose-escalation.
Measured: through the duration of treatment, up to approximately 12 months
Phase 1b: Dose Expansion: Objective response rate
Objective response rate based on best overall response (BOR) will be assessed by investigators according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1).
Measured: through the duration of treatment, up to approximately 12 months
Phase 1b: Dose Expansion: Number of participants reporting AEs and SAEs
The type, incidence, and severity of AEs and SAEs will be determined using the NCI CTCAE v5.0.
Measured: through the duration of treatment, up to approximately 12 months
Phase 1b: Dose Expansion: Frequency of dose interruptions
The frequency at which dose interruptions occur during dose-expansion.
Measured: through the duration of treatment, up to approximately 12 months
Phase 1b: Dose Expansion: Duration of dose interruption
The duration of dose interruptions that occur during dose-expansion.
Measured: through the duration of treatment, up to approximately 12 months
Phase 1b: Dose Expansion: Frequency of dose reductions
The frequency at which dose reductions occur during dose-expansion.
Measured: through the duration of treatment, up to approximately 12 months
Phase 1b: Dose Expansion: Duration of dose reductions
The duration of dose reductions that occur during dose-expansion.
Measured: through the duration of treatment, up to approximately 12 months
Secondary outcomes (11)
Phase 1a and Phase 1b: Maximum concentration (Cmax) of DAY301
Blood samples will be collected at indicated time points for the analysis of pharmacokinetic parameters.
Measured: Varying timepoints through the duration of treatment, up to approximately 12 months
Phase 1a and Phase 1b: time to Cmax (Tmax) of DAY301
Blood samples will be collected at indicated time points for the analysis of pharmacokinetic parameters.
Measured: Varying timepoints through the duration of treatment, up to approximately 12 months
Phase 1a and Phase 1b: area under the curve (AUC) of DAY301
Blood samples will be collected at indicated time points for the analysis of pharmacokinetic parameters.
Measured: Varying timepoints through the duration of treatment, up to approximately 12 months
Phase 1a and Phase 1b: terminal half-life (t1/2) of DAY301
Blood samples will be collected at indicated time points for the analysis of pharmacokinetic parameters.
Measured: Varying timepoints through the duration of treatment, up to approximately 12 months
Phase 1a Dose Escalation: Objective response rate
Objective response rate based on BOR will be assessed by investigators according to RECIST v1.1.
Measured: through the duration of treatment, up to approximately 12 months
Phase 1a and 1b: Clinical Benefit rate (CBR)
Clinical Benefit rate will be assessed by investigators according to RECIST v1.1.
Measured: through the duration of treatment, up to approximately 12 months
Phase 1a and 1b: duration of response (DOR)
Duration of response will be assessed by investigators according to RECIST v1.1.
Measured: through the duration of treatment, up to approximately 12 months
Phase 1a and 1b: time to response (TTR)
Time to response will be assessed by investigators according to RECIST v1.1.
Measured: through the duration of treatment, up to approximately 12 months
Phase 1a and 1b: Progression-free survival
Progression-free survival will be assessed by investigators according to RECIST v1.1.
Measured: through the duration of treatment, up to approximately 12 months
Phase 1b: Overall survival
Overall survival will be assessed by investigators.
Measured: through the duration of treatment, up to approximately 12 months
Phase 1a and 1b: Number of participants with positive antidrug antibodies (ADAs)
Assessed by the measure of anti-drug antibodies in serum.
Measured: varying timepoints through the duration of treatment, up to approximately 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2024
- Study start18 Nov 2024
- Primary completionDec 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced or Metastatic Solid TumorsStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Day One Biopharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06752681
- Sponsor's protocol ID
- DAY301-001
- Status last verified
- Jul 2026
- First submitted
- 23 Dec 2024
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06752681
- Acronym / sponsor ID
- DAY301-001
- Conditions
- Advanced or Metastatic Solid Tumors
- Keywords
- Advanced or metastatic solid tumors, Dose Escalation, Dose Expansion, DAY301, PTK7-Targeted Antibody-drug Conjugate
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Day One Biopharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 18 Nov 2024 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 31 Dec 2024 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DAY301 intravenous (IV) infusion | Experimental | Drug: DAY301DAY301 will be administered at different dose levels in dose escalation and at the RD in dose expansion cohorts. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (10 listed)
- 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 criteria:
- 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.
- Active or progressing brain metastases or evidence of leptomeningeal disease.
- Persistent toxicities from previous systemic antineoplastic treatments of Grade >1, excluding alopecia and vitiligo.
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 |
|---|---|---|
| DAY301DAY301 will be administered as IV infusion | Drug | DAY301 intravenous (IV) infusion |
Primary outcome
Phase 1a: Dose Escalation: Number of participants with reported Dose Limiting Toxicities (DLTs)
Time frame: Within 21 days of first infusion (Day 1)
To evaluate adverse events (AEs) considered dose limiting toxicities that occur in the first cycle of treatment (within a DLT observation period).
Phase 1a: Dose Escalation: Number of participants with reported adverse events (AEs) and serious AEs (SAEs)
Time frame: through the duration of treatment, up to approximately 12 months
The type, incidence, and severity of AEs and SAEs will be determined using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Phase 1a: Dose Escalation: Frequency of dose interruptions
Time frame: through the duration of treatment, up to approximately 12 months
The frequency at which dose interruptions occur during dose-escalation
Phase 1a: Dose Escalation: Duration of dose interruptions
Time frame: through the duration of treatment, up to approximately 12 months
The duration of dose interruptions that occur during dose-escalation.
Phase 1a: Dose Escalation: Frequency of dose reductions
Time frame: through the duration of treatment, up to approximately 12 months
The frequency at which dose reductions occur during dose-escalation.
Phase 1a: Dose Escalation: Duration of dose reductions
Time frame: through the duration of treatment, up to approximately 12 months
The duration of dose reductions that occur during dose-escalation.
Phase 1b: Dose Expansion: Objective response rate
Time frame: through the duration of treatment, up to approximately 12 months
Objective response rate based on best overall response (BOR) will be assessed by investigators according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1).
Phase 1b: Dose Expansion: Number of participants reporting AEs and SAEs
Time frame: through the duration of treatment, up to approximately 12 months
The type, incidence, and severity of AEs and SAEs will be determined using the NCI CTCAE v5.0.
Phase 1b: Dose Expansion: Frequency of dose interruptions
Time frame: through the duration of treatment, up to approximately 12 months
The frequency at which dose interruptions occur during dose-expansion.
Phase 1b: Dose Expansion: Duration of dose interruption
Time frame: through the duration of treatment, up to approximately 12 months
The duration of dose interruptions that occur during dose-expansion.
Phase 1b: Dose Expansion: Frequency of dose reductions
Time frame: through the duration of treatment, up to approximately 12 months
The frequency at which dose reductions occur during dose-expansion.
Phase 1b: Dose Expansion: Duration of dose reductions
Time frame: through the duration of treatment, up to approximately 12 months
The duration of dose reductions that occur during dose-expansion.
11 secondary outcomes
Phase 1a and Phase 1b: Maximum concentration (Cmax) of DAY301
Time frame: Varying timepoints through the duration of treatment, up to approximately 12 months
Phase 1a and Phase 1b: time to Cmax (Tmax) of DAY301
Time frame: Varying timepoints through the duration of treatment, up to approximately 12 months
Phase 1a and Phase 1b: area under the curve (AUC) of DAY301
Time frame: Varying timepoints through the duration of treatment, up to approximately 12 months
Phase 1a and Phase 1b: terminal half-life (t1/2) of DAY301
Time frame: Varying timepoints through the duration of treatment, up to approximately 12 months
Phase 1a Dose Escalation: Objective response rate
Time frame: through the duration of treatment, up to approximately 12 months
Phase 1a and 1b: Clinical Benefit rate (CBR)
Time frame: through the duration of treatment, up to approximately 12 months
Phase 1a and 1b: duration of response (DOR)
Time frame: through the duration of treatment, up to approximately 12 months
Phase 1a and 1b: time to response (TTR)
Time frame: through the duration of treatment, up to approximately 12 months
Phase 1a and 1b: Progression-free survival
Time frame: through the duration of treatment, up to approximately 12 months
Phase 1b: Overall survival
Time frame: through the duration of treatment, up to approximately 12 months
Phase 1a and 1b: Number of participants with positive antidrug antibodies (ADAs)
Time frame: varying timepoints through the duration of treatment, up to approximately 12 months
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 22 Jul 2026.
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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.
11 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 DAY301 in people with Advanced or Metastatic Solid Tumors, run by Day One Biopharmaceuticals, Inc. at 11 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 14 inclusion and 10 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 22 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 11 sites in United States, Canada. 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 Day One Clinical Trials Information (650-484-0899, clinicaltrials@dayonebio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase 1a: Dose Escalation: Number of participants with reported Dose Limiting Toxicities (DLTs) (time frame: Within 21 days of first infusion (Day 1)). The study lists 12 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 22 Jul 2026.