Advanced or Metastatic Solid Tumors
Conditions
Keywords
Advanced or metastatic solid tumors, Dose Escalation, Dose Expansion, DAY301, PTK7-Targeted Antibody-drug Conjugate
Brief 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. 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.
Interventions
DRUGDAY301
DAY301 will be administered as IV infusion
Sponsors
Day One Biopharmaceuticals, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 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.
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Phase 1a: Dose Escalation: Number of participants with reported Dose Limiting Toxicities (DLTs) | 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) | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | through the duration of treatment, up to approximately 12 months | The duration of dose reductions that occur during dose-expansion. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Phase 1a and Phase 1b: Maximum concentration (Cmax) of DAY301 | 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. |
| Phase 1a and Phase 1b: time to Cmax (Tmax) of DAY301 | 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. |
| Phase 1a and Phase 1b: area under the curve (AUC) of DAY301 | 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. |
| Phase 1a and Phase 1b: terminal half-life (t1/2) of DAY301 | 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. |
| Phase 1a Dose Escalation: Objective response rate | 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. |
| Phase 1a and 1b: Clinical Benefit rate (CBR) | through the duration of treatment, up to approximately 12 months | Clinical Benefit rate will be assessed by investigators according to RECIST v1.1. |
| Phase 1a and 1b: duration of response (DOR) | through the duration of treatment, up to approximately 12 months | Duration of response will be assessed by investigators according to RECIST v1.1. |
| Phase 1a and 1b: time to response (TTR) | through the duration of treatment, up to approximately 12 months | Time to response will be assessed by investigators according to RECIST v1.1. |
| Phase 1a and 1b: Progression-free survival | through the duration of treatment, up to approximately 12 months | Progression-free survival will be assessed by investigators according to RECIST v1.1. |
| Phase 1b: Overall survival | through the duration of treatment, up to approximately 12 months | Overall survival will be assessed by investigators. |
| Phase 1a and 1b: Number of participants with positive antidrug antibodies (ADAs) | varying timepoints through the duration of treatment, up to approximately 12 months | Assessed by the measure of anti-drug antibodies in serum. |
Countries
Canada, United States
Contacts
CONTACTDay One Clinical Trials Information
Outcome results
None listed