To Evaluate the Safety, Tolerability, Pharmacokinetics and Antitumor Activity of DAY301 in Participants With Locally Advanced or Metastatic Solid Tumors
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
Day One Biopharmaceuticals, Inc.
254 participants
Nov 18, 2024
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria15
- 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
- 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 Criteria9
- 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).
- Cohort 1: Neuroendocrine tumors or endometrial sarcoma (eg, stromal sarcoma, leiomyosarcoma, or other types of pure sarcomas)
- 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)
- 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.
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Interventions
DAY301 will be administered as IV infusion
Locations(12)
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NCT06752681