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
Investigating the Safety and Effects of an Investigational Antibody-Drug Conjugate in Solid Tumors
Greg Durm, MD
Primary Investigator
Brief description of study
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 patients with advanced or metastatic solid tumors.
Detailed description of study
The study comprises of 2 phases: Phase 1a dose escalation where patients 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 of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Advanced Solid Tumors, Metastatic Tumors, Cancer
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Age: 18 years - 100 years
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Gender: All
Inclusion Criteria:
- Patients with 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
(Patients 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 (RECIST v1.1).
- ECOG performance status of 0 or 1.
- Adequate organ function.
Exclusion Criteria:
- Prior use of PTK7 targeting treatment.
- 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 5 half-lives or 4 weeks, whichever is shorter, prior to first dose of the study drug, including investigational agents.
This study investigates the safety and effects of an investigational antibody-drug conjugate in patients with advanced or metastatic solid tumors. The purpose is to understand how the investigational medication works in the body and its impact on tumors. Advanced or metastatic solid tumors are cancers that have spread beyond their original site and are difficult to treat.
The study involves two phases. In the first phase, patients receive increasing doses of the investigational medication to find the safest and most effective dose. In the second phase, more patients receive the medication at the chosen dose to further evaluate its effects. Participants will undergo regular health checks and tumor assessments to monitor their response to the treatment.
- Who can participate: Adults with advanced or metastatic solid tumors, like ovarian, esophageal, or breast cancer, who have received standard treatments or have no standard options available, may join. Tumor tissue samples and measurable disease are required.
- Study details: Participants will receive the investigational medication and attend regular health check-ups and tumor assessments. A placebo is not used.
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