To Evaluate the Safety, Tolerability, Pharmacokinetics and Antitumor Activity of DAY301 in Participants With Locally Advanced or Metastatic Solid Tumors
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.
You may not be if
Prior use of PTK7 targeting treatment (Phase 1a) or prior use of PTK7 targeting treatments and/or topoisomerase 1 (TOP1) inhibitors (Phase 1b).
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.
Clareo Health | To Evaluate the Safety, Tolerability, Pharmacokinetics and Antitumor Activity of DAY301 in Participants With Locally Advanced or Metastatic Solid Tumors
