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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 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DAY301 intravenous (IV) infusion | Experimental | DAY301 will be administered at different dose levels in dose escalation and at the RD in dose expansion cohorts. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DAY301 | Drug | DAY301 will be administered as IV infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Within 21 days of first infusion (Day 1) |
| Phase 1a: Dose Escalation: Number of participants with reported adverse events (AEs) or 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. | 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 | 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. | 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. | 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. | through the duration of treatment, up to approximately 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Varying timepoints through the duration of treatment, up to approximately 12 months |
| Phase 1a and Phase 1b: time to Cmax (Tmax) of DAY301 |
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Inclusion Criteria:
(Participants must have been previously treated with standard of care systemic therapy, or for whom no standard therapy is available).
Exclusion Criteria:
Prior use of PTK7 targeting treatment (Phase 1a) or prior use of PTK7 targeting treatments and/or topoisomerase 1 (TOP1) inhibitor-based antibody-drug conjugate (ADC) (Phase 1b).
Phase 1b disease-specific exclusion criteria:
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.
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Day One Clinical Trials Information | Contact | 650-484-0899 | clinicaltrials@dayonebio.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site: 001-058 | Recruiting | New Haven | Connecticut | 06510 | United States | |
| Site: 001-063 |
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| 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). | through the duration of treatment, up to approximately 12 months-up |
| 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. | 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. | 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. | 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. | 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. | through the duration of treatment, up to approximately 12 months |
Blood samples will be collected at indicated time points for the analysis of pharmacokinetic parameters. |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | through the duration of treatment, up to approximately 12 months |
| Phase 1b: Overall survival | Overall survival will be assessed by investigators. | 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. | varying timepoints through the duration of treatment, up to approximately 12 months |
| Recruiting |
| Lake Mary |
| Florida |
| 32746 |
| United States |
| Site: 001-064 | Recruiting | Sarasota | Florida | 34232 | United States |
| Site: 001-060 | Recruiting | Indianapolis | Indiana | 46202 | United States |
| Site: 001-059 | Recruiting | Grand Rapids | Michigan | 49546 | United States |
| Site: 001-039 | Recruiting | New York | New York | 10021 | United States |
| Site: 001-073 | Recruiting | Oklahoma City | Oklahoma | 73104 | United States |
| Site: 001-065 | Recruiting | Nashville | Tennessee | 37203 | United States |
| Site: 001-069 | Recruiting | Houston | Texas | 77030 | United States |
| Site: 001-057 | Recruiting | San Antonio | Texas | 78229 | United States |
| Site: 011-013 | Recruiting | Vancouver | British Columbia | V5Z 4E6 | Canada |
| Site: 011-005 | Recruiting | Toronto | Ontario | M5G 2M9 | Canada |