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
Day One Biopharmaceuticals, Inc.
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 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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- 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 * Gastric/gastroesophageal junction adenocarcinoma * Cervical squamous cell carcinoma * Endometrial cancers (Participants must have been previously treated with standard of care systemic therapy, or for whom no standard therapy is available). * Availability of tumor tissue…
Interventions
- DrugDAY301
DAY301 will be administered as IV infusion
Locations (12)
- Site: 001-058New Haven, Connecticut
- Site: 001-063Lake Mary, Florida
- Site: 001-064Sarasota, Florida
- Site: 001-060Indianapolis, Indiana
- Site: 001-059Grand Rapids, Michigan
- Site: 001-039New York, New York