NCT06752681 To Evaluate the Safety, Tolerability, Pharmacokinetics and Antitumor Activity of DAY301 in Participants With Locally Advanced or Metastatic Solid Tumors

Eligibility & Interventions

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.

This trial targets 300 participants in total. It began in 2024-11-18 with a primary completion date of 2027-12.

Brief 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 (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.

Eligibility Criteria

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.

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