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

Launched by DAY ONE BIOPHARMACEUTICALS, INC. · Dec 23, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called DAY301 for patients with advanced or metastatic solid tumors, which are cancers that have spread beyond their original location. The trial aims to find out how safe DAY301 is, how well it works to fight cancer, and what the best dose is for patients. It consists of two parts: the first part will test different doses of DAY301 to determine the safest and most effective amount, while the second part will focus on giving this dose to a larger group of patients to see how well it works.

To join the trial, participants should have certain types of advanced cancer, such as ovarian cancer or triple-negative breast cancer, and they must have already received standard treatments. They also need to have a recent tumor sample available for testing. Patients can expect to receive the treatment at a medical facility, undergo regular check-ups, and be closely monitored for any side effects. It's important to note that this trial is currently recruiting participants, so if you or someone you know is interested, it could be a chance to access a new treatment option.

Gender

ALL

Eligibility criteria

• 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.
• • Note: Other protocol defined Inclusion/Exclusion criteria may apply.