BridgeMD
Tests treatment safety and results for Advanced or Metastatic Solid Tumors
Official title To Evaluate the Safety, Tolerability, Pharmacokinetics and Antitumor Activity of DAY301 in Participants With Locally Advanced or Metastatic Solid Tumors
ClinicalTrials.gov ID: NCT06752681
What this study is testing
What is DAY301?
DAY301 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for advanced or metastatic solid tumors.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- Prior use of PTK7 targeting treatment (Phase 1a) or prior use of PTK7 targeting treatments and/or topoisomerase 1 (TOP1) inhibitor-based...
- Phase 1b disease-specific exclusion criteria:
- 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...
- Cohort 3: nasopharyngeal primary tumors.
- History of small bowel obstruction requiring hospitalization within 3 months prior to the first dose of study treatment.
See the full eligibility 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
- 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.
- 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).
- Phase 1b disease-specific exclusion criteria:
- 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...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- New Haven, Connecticut, United States
- Lake Mary, Florida, United States
- Sarasota, Florida, United States
- Indianapolis, Indiana, United States
- Grand Rapids, Michigan, United States
- New York, New York, United States
- Oklahoma City, Oklahoma, United States
- Nashville, Tennessee, United States
- Houston, Texas, United States
- San Antonio, Texas, United States
- Vancouver, British Columbia, Canada
- Toronto, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New Haven, Connecticut, United States; Lake Mary, Florida, United States; Sarasota, Florida, United States; Indianapolis, Indiana, United States; Grand Rapids, Michigan, United States; New York, New York, United States and 6 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.