RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-11-18
Study Completion:2028-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06752681

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Histologically or cytologically confirmed diagnosis of advanced or metastatic solid tumors of the following histologies:
  2. * Ovarian cancer
  3. * Esophageal squamous cell carcinoma
  4. * Triple-negative breast cancer
  5. * Non-small cell lung cancer
  6. * Small cell lung cancer
  7. * Head and neck squamous cell carcinoma
  8. * Gastric/gastroesophageal junction adenocarcinoma
  9. * Cervical squamous cell carcinoma
  10. * Endometrial cancers
  11. * Availability of tumor tissue sample (either an archival specimen or a fresh biopsy) at screening
  12. * Measurable disease per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1).
  13. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  14. * Adequate organ function.
  1. * 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).
  2. * Phase 1b disease-specific

Contacts and Locations

Study Contact

Day One Clinical Trials Information
CONTACT
650-484-0899
clinicaltrials@dayonebio.com

Study Locations (Sites)

Site: 001-058
New Haven, Connecticut, 06510
United States
Site: 001-063
Lake Mary, Florida, 32746
United States
Site: 001-064
Sarasota, Florida, 34232
United States
Site: 001-060
Indianapolis, Indiana, 46202
United States
Site: 001-059
Grand Rapids, Michigan, 49546
United States
Site: 001-039
New York, New York, 10021
United States
Site: 001-073
Oklahoma City, Oklahoma, 73104
United States
Site: 001-065
Nashville, Tennessee, 37203
United States
Site: 001-069
Houston, Texas, 77030
United States
Site: 001-057
San Antonio, Texas, 78229
United States

Collaborators and Investigators

Sponsor: Day One Biopharmaceuticals, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-11-18
Study Completion Date2028-12

Study Record Updates

Study Start Date2024-11-18
Study Completion Date2028-12

Terms related to this study

Keywords Provided by Researchers

  • Advanced or metastatic solid tumors
  • Dose Escalation
  • Dose Expansion
  • DAY301
  • PTK7-Targeted Antibody-drug Conjugate

Additional Relevant MeSH Terms

  • Advanced or Metastatic Solid Tumors