Actively Recruiting
To Evaluate the Safety, Tolerability, Pharmacokinetics and Antitumor Activity of DAY301 in Participants With Locally Advanced or Metastatic Solid Tumors
Led by Day One Biopharmaceuticals, Inc. · Updated on 2025-10-10
254
Participants Needed
12
Research Sites
210 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
To Evaluate the Safety, Tolerability, Pharmacokinetics and Antitumor Activity of DAY301 in Participants With Locally Advanced or Metastatic Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed advanced or metastatic solid tumors including 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, or endometrial cancers
- Prior treatment with standard systemic therapy or no available standard therapy
- Availability of tumor tissue sample at screening
- Measurable disease per RECIST v1.1
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate organ function
You will not qualify if you...
- Prior use of PTK7 targeting treatment for Phase 1a or PTK7 targeting and/or topoisomerase 1 inhibitor-based antibody-drug conjugate for Phase 1b
- For Phase 1b cohorts: neuroendocrine tumors or endometrial sarcoma in Cohort 1; platinum-sensitive or primary platinum-refractory ovarian cancer in Cohort 2; nasopharyngeal primary tumors in Cohort 3
- History of small bowel obstruction requiring hospitalization within 3 months before first dose
- Ascites requiring frequent paracentesis or new onset within 4 weeks before first dose
- Active or progressing brain metastases or leptomeningeal disease
- Persistent toxicities from previous antineoplastic treatments above Grade 1, except alopecia and vitiligo
- Systemic antineoplastic therapy within five half-lives or 4 weeks prior to first dose, whichever is shorter, including investigational agents
- Other protocol defined criteria may apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 12 locations
1
Site: 001-058
New Haven, Connecticut, United States, 06510
Actively Recruiting
2
Site: 001-063
Lake Mary, Florida, United States, 32746
Actively Recruiting
3
Site: 001-064
Sarasota, Florida, United States, 34232
Actively Recruiting
4
Site: 001-060
Indianapolis, Indiana, United States, 46202
Actively Recruiting
5
Site: 001-059
Grand Rapids, Michigan, United States, 49546
Actively Recruiting
6
Site: 001-039
New York, New York, United States, 10021
Actively Recruiting
7
Site: 001-073
Oklahoma City, Oklahoma, United States, 73104
Actively Recruiting
8
Site: 001-065
Nashville, Tennessee, United States, 37203
Actively Recruiting
9
Site: 001-069
Houston, Texas, United States, 77030
Actively Recruiting
10
Site: 001-057
San Antonio, Texas, United States, 78229
Actively Recruiting
11
Site: 011-013
Vancouver, British Columbia, Canada, V5Z 4E6
Actively Recruiting
12
Site: 011-005
Toronto, Ontario, Canada, M5G 2M9
Actively Recruiting
Research Team
D
Day One Clinical Trials Information
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here