To Evaluate the Safety, Tolerability, Pharmacokinetics and Antitumor Activity of DAY301 in Participants With Locally Advanced or Metastatic Solid Tumors
Purpose
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 (ADC) 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.
Condition
- Advanced or Metastatic Solid Tumors
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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 - Cervical squamous cell carcinoma - Endometrial cancers (Participants must have been previously treated with standard of care systemic therapy, have refused standard therapy, or have no standard therapy 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) inhibitors (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: Nasopharyngeal primary tumors. 3. Cohort 3: Ovarian cancer that progressed >6 months after the last dose of platinum-based chemotherapy (platinum-sensitive disease), or disease that did not respond (PR or complete response [CR]) to or progressed ≤91 days after the last dose of first-line platinum-based chemotherapy (primary platinum-refractory disease) .- 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.
Study Design
- Phase
- Phase 1
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental DAY301 intravenous (IV) infusion |
DAY301 will be administered at different dose levels in dose escalation and at the RD in dose expansion cohorts. |
|
Recruiting Locations
Site: 001-058
New Haven, Connecticut 06511
New Haven, Connecticut 06511
Site: 001-064
Sarasota, Florida 34232
Sarasota, Florida 34232
Site: 001-060
Avon, Indiana 46202
Avon, Indiana 46202
Site: 001-059
Grand Rapids, Michigan 49546
Grand Rapids, Michigan 49546
Site: 001-039
New York, New York 10065
New York, New York 10065
Site: 001-073
Oklahoma City, Oklahoma 73104
Oklahoma City, Oklahoma 73104
Site: 001-065
Nashville, Tennessee 37203
Nashville, Tennessee 37203
Site: 001-069
Houston, Texas 77030
Houston, Texas 77030
Site: 001-057
San Antonio, Texas 78240
San Antonio, Texas 78240
More Details
- Status
- Recruiting
- Sponsor
- Day One Biopharmaceuticals, Inc.