To Evaluate the Safety, Tolerability, Pharmacokinetics and Antitumor Activity of DAY301 in Participants With Locally Advanced or Metastatic Solid Tumors
NCT ID: NCT06752681
Last Updated: 2025-10-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
254 participants
INTERVENTIONAL
2024-11-18
2028-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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DAY301 intravenous (IV) infusion
DAY301 will be administered at different dose levels in dose escalation and at the RD in dose expansion cohorts.
DAY301
DAY301 will be administered as IV infusion
Interventions
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DAY301
DAY301 will be administered as IV infusion
Eligibility Criteria
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Inclusion Criteria
* 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
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.
18 Years
ALL
No
Sponsors
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Day One Biopharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Central Contacts
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Other Identifiers
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DAY301-001
Identifier Type: -
Identifier Source: org_study_id
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