DAY301
DrugDAY301 will be administered as IV infusion
NCT Number: NCT06752681
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 1
Site: 011-013, Vancouver, British Columbia, Canada
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
(Participants must have been previously treated with standard of care systemic therapy, have refused standard therapy, or have no standard therapy available).
Exclusion criteria
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
DAY301 will be administered as IV infusion
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).
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.
Time frame: through the duration of treatment, up to approximately 12 months
The frequency at which dose interruptions occur during dose-escalation
Time frame: through the duration of treatment, up to approximately 12 months
The duration of dose interruptions that occur during dose-escalation.
Time frame: through the duration of treatment, up to approximately 12 months
The frequency at which dose reductions occur during dose-escalation.
Time frame: through the duration of treatment, up to approximately 12 months
The duration of dose reductions that occur during dose-escalation.
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).
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.
Time frame: through the duration of treatment, up to approximately 12 months
The frequency at which dose interruptions occur during dose-expansion.
Time frame: through the duration of treatment, up to approximately 12 months
The duration of dose interruptions that occur during dose-expansion.
Time frame: through the duration of treatment, up to approximately 12 months
The frequency at which dose reductions occur during dose-expansion.
Time frame: through the duration of treatment, up to approximately 12 months
The duration of dose reductions that occur during dose-expansion.
Time frame: Varying timepoints 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.
Time frame: Varying timepoints 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.
Time frame: Varying timepoints 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.
Time frame: Varying timepoints 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.
Time frame: through the duration of treatment, up to approximately 12 months
Objective response rate based on BOR will be assessed by investigators according to RECIST v1.1.
Time frame: through the duration of treatment, up to approximately 12 months
Clinical Benefit rate will be assessed by investigators according to RECIST v1.1.
Time frame: through the duration of treatment, up to approximately 12 months
Duration of response will be assessed by investigators according to RECIST v1.1.
Time frame: through the duration of treatment, up to approximately 12 months
Time to response will be assessed by investigators according to RECIST v1.1.
Time frame: through the duration of treatment, up to approximately 12 months
Progression-free survival will be assessed by investigators according to RECIST v1.1.
Time frame: through the duration of treatment, up to approximately 12 months
Overall survival will be assessed by investigators.
Time frame: varying timepoints through the duration of treatment, up to approximately 12 months
Assessed by the measure of anti-drug antibodies in serum.
Contact information is provided by the study sponsor or research team.
Day One Biopharmaceuticals, Inc.
Industry
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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