RecruitingPhase 1NCT06752681

To Evaluate the Safety, Tolerability, Pharmacokinetics and Antitumor Activity of DAY301 in Participants With Locally 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


Sponsor

Day One Biopharmaceuticals, Inc.

Enrollment

254 participants

Start Date

Nov 18, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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 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.


Eligibility

Min Age: 18 Years

Inclusion Criteria15

  • 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 Criteria9

  • 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).
  • Cohort 1: Neuroendocrine tumors or endometrial sarcoma (eg, stromal sarcoma, leiomyosarcoma, or other types of pure sarcomas)
  • 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)
  • 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.

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Interventions

DRUGDAY301

DAY301 will be administered as IV infusion


Locations(12)

Site: 001-058

New Haven, Connecticut, United States

Site: 001-063

Lake Mary, Florida, United States

Site: 001-064

Sarasota, Florida, United States

Site: 001-060

Indianapolis, Indiana, United States

Site: 001-059

Grand Rapids, Michigan, United States

Site: 001-039

New York, New York, United States

Site: 001-073

Oklahoma City, Oklahoma, United States

Site: 001-065

Nashville, Tennessee, United States

Site: 001-069

Houston, Texas, United States

Site: 001-057

San Antonio, Texas, United States

Site: 011-013

Vancouver, British Columbia, Canada

Site: 011-005

Toronto, Ontario, Canada

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NCT06752681


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