Evaluating a new treatment for advanced or metastatic solid tumors

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

This study is testing a new treatment for people with advanced or metastatic solid tumors to see if it is safe and effective after they have tried other therapies.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 254 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Day One Biopharmaceuticals, Inc. (industry)
• Drugs / interventions: chemotherapy
• Locations: 12 sites (New Haven, Connecticut and 11 other locations)
• Trial ID: NCT06752681 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include patients with specific types of advanced or metastatic solid tumors who have previously undergone standard therapy.

Not a fit: Patients with active brain metastases or those who have previously received PTK7-targeting treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced or metastatic solid tumors who have limited treatment choices.

How similar studies have performed: Other studies involving antibody-drug conjugates have shown promising results, indicating potential for success with this novel approach.

Eligibility criteria

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 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) inhibitor-based antibody-drug conjugate (ADC) (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: Ovarian cancer that progressed \>6 months after the last dose of platinum-based chemotherapy (platinum-sensitive disease), or disease that did not respond (partial response \[PR\] or complete response \[CR\]) to or progressed ≤91 days after the last dose of first-line platinum-based chemotherapy (primary platinum-refractory disease)
  3. Cohort 3: nasopharyngeal primary tumors.
* 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 this trial is running

New Haven, Connecticut and 11 other locations

• Site: 001-058 — New Haven, Connecticut, United States (RECRUITING)
• Site: 001-063 — Lake Mary, Florida, United States (RECRUITING)
• Site: 001-064 — Sarasota, Florida, United States (RECRUITING)
• Site: 001-060 — Indianapolis, 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)
• Site: 001-065 — Nashville, Tennessee, United States (RECRUITING)
• Site: 001-069 — Houston, Texas, United States (RECRUITING)
• Site: 001-057 — San Antonio, Texas, United States (RECRUITING)
• Site: 011-013 — Vancouver, British Columbia, Canada (RECRUITING)
• Site: 011-005 — Toronto, Ontario, Canada (RECRUITING)

Study contacts

• Study coordinator: Day One Clinical Trials Information

Conditions: Advanced or Metastatic Solid Tumors, Advanced or metastatic solid tumors, Dose Escalation, Dose Expansion, DAY301, PTK7-Targeted Antibody-drug Conjugate