Evaluating a new treatment for advanced or metastatic solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1a/1b clinical trial assesses the safety, tolerability, pharmacokinetics, and anti-tumor activity of DAY301, a PTK7-targeted antibody-drug conjugate, in patients with advanced or metastatic solid tumors. The study consists of two phases: the first phase involves dose escalation to determine the maximum tolerated dose, while the second phase focuses on dose expansion to further evaluate the treatment's efficacy. Participants must have previously received standard systemic therapy or have no available standard treatment options.

Why it matters

Who can join: the full rules

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
* 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.

Exclusion Criteria:

* 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:

  1. Cohort 1: Neuroendocrine tumors or endometrial sarcoma (eg, stromal sarcoma, leiomyosarcoma, or other types of pure sarcomas)
  2. Cohort 2: Nasopharyngeal primary tumors.
  3. 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's running

• Site: 001-058
  New Haven, Connecticut, United States Recruiting
• Site: 001-064
  Sarasota, Florida, United States Recruiting
• Site: 001-060
  Avon, Indiana, United States Recruiting
• Site: 001-059
  Grand Rapids, Michigan, United States Recruiting
• Site: 001-039
  New York, New York, United States Recruiting
• Site: 001-073
  Oklahoma City, Oklahoma, United States Recruiting

Study contacts

• Study coordinator: Day One Clinical Trials Information
• Email: clinicaltrials@dayonebio.com
• Phone: 650-484-0899

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.