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
Mateusz Opyrchal, MD, PhD
Principal Investigator
Brief Description
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 patients with advanced or metastatic solid tumors.
Detailed Description
The study comprises of 2 phases: Phase 1a dose escalation where patients 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 of study
Inclusion Criteria:
- Patients with 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
(Patients must have been previously treated with standard of care systemic therapy, or for whom no standard therapy is 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 (RECIST v1.1).
- ECOG performance status of 0 or 1.
- Adequate organ function.
Exclusion Criteria:
- Prior use of PTK7 targeting treatment.
- 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 5 half-lives or 4 weeks, whichever is shorter, prior to first dose of the study drug, including investigational agents.