To Evaluate the Safety, Tolerability, Pharmacokinetics and Antitumor Activity of DAY301 in Participants With Locally Advanced or Metastatic Solid Tumors

Recruiting now · Phase 1

Conditions studied: Advanced or Metastatic Solid Tumors

In brief

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.

Key facts

Study ID

NCT06752681

Run by

Day One Biopharmaceuticals, Inc.

People needed

300

Starts

2024-11-18

Expected to finish

2028-12-01

Last updated by the study team

2026-07-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 exclusion criteria:
• 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.
• Ascites requiring frequent paracentesis (more often than approximately every 4 weeks) for symptomatic management, or new onset within 4 weeks prior to the first dose of study treatment. Patients with an indwelling catheter may be considered eligible, after consultation with the medical monitor.
• 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 five half-lives or 4 weeks, whichever is shorter, prior to first dose of study treatment, including investigational agents.
• Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Where it is running

• Site: 001-058 — New Haven, Connecticut, United States (enrolling)
• Site: 001-064 — Sarasota, Florida, United States (enrolling)
• Site: 001-060 — Avon, Indiana, United States (enrolling)
• Site: 001-059 — Grand Rapids, Michigan, United States (enrolling)
• Site: 001-039 — New York, New York, United States (enrolling)
• Site: 001-073 — Oklahoma City, Oklahoma, United States (enrolling)
• Site: 001-065 — Nashville, Tennessee, United States (enrolling)
• Site: 001-069 — Houston, Texas, United States (enrolling)
• Site: 001-057 — San Antonio, Texas, United States (enrolling)
• Site: 011-013 — Vancouver, British Columbia, Canada (enrolling)
• Site: 011-005 — Toronto, Ontario, Canada (enrolling)

Full record on ClinicalTrials.gov

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