Safety and Preliminary Efficacy of BNT314 in Cancer Patients With Malignant Solid Tumors (NCT06150183)
A First-in-Human, Open-label, Dose Escalation Trial With Expansion Cohorts to Evaluate the Safety and Preliminary Efficacy of BNT314 as Monotherapy in Patients With Advanced Malignant Solid Tumors
🩺 Plain-English Summary (8th-Grade Level)
The purpose of this first-in-human study is to find out if BNT314 is safe when it is used alone in patients with different types of cancer. This is a dose escalation study in which patients will be assigned to multiple dose levels (DLs) of BNT314 given alone. By escalating the dose with a small group of patients, the Maximum Tolerated Dose which is the highest dose with acceptable safety and manageable side effects, or the maximum administered dose will be investigated.
Who can join: Review the eligibility criteria below.
Location: START Midwest — Grand Rapids, Michigan
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (14 Sites)
- START Midwest — Grand Rapids, Michigan
- Carolina BioOncology Institute, LLC — Huntersville, North Carolina
- Cleveland Clinic — Cleveland, Ohio
- GZA Ziekenhuizen — Antwerp,
- CHU de Liège — Liège,
- Rigshospitalet — Copenhagen,
- National Cancer Center Hospital East — Kashiwanoha,
- Hospital Quironsalud Barcelona (NEXT Barcelona) — Barcelona,
- Hospital Fund. Jiménez Dia — Madrid,
- Hospital HM Univ. Sanchinarro, Ensayos START — Madrid,
- Clinica Universidad de Navarra — Pamplona,
- Royal Marsden Hospital - London — London,
- The Christie Hospital — Manchester,
- Northern Centre for Cancer Care — Newcastle,
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Advanced Malignant Solid Tumor
- An Early Phase Trial of RPTR-1-201 in Advanced Solid Tumors — Grand Rapids, Michigan
- A First in Human Study of PLT012 in Participants With Solid Tumor Cancers — Los Angeles, California
Explore by condition: All Advanced Malignant Solid Tumor clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.