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.
Ovarian cancer
Esophageal squamous cell carcinoma
Triple-negative breast cancer
Non-small cell lung cancer
Prior use of PTK7 targeting treatment (Phase 1a) or prior use of PTK7 targeting treatments and/or topoisomerase 1 (TOP1) inhibitors (Phase 1b).
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.
Single group
DAY301
DrugDAY301 will be administered as IV infusion
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).
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.
Phase 1a: Dose Escalation: Frequency of dose interruptions
The frequency at which dose interruptions occur during dose-escalation
Phase 1a: Dose Escalation: Duration of dose interruptions
The duration of dose interruptions that occur during dose-escalation.
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.
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.
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.
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.
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