First in Human Study of TUB-030 in Patients With Advanced Solid Tumors (NCT06657222)
A Multicenter FIH Dose Escalation and Optimization Phase I/IIa Trial to Investigate Safety, Tolerability, PK, and Efficacy of the 5T4 ADC TUB-030 in Patients With Advanced Solid Tumors (5-STAR 1-01)
🩺 Plain-English Summary (8th-Grade Level)
The goal of this clinical trial is to learn if the drug TUB-030 works to treat solid cancer in adults. The study will also explore the safety of TUB-030. The main questions it aims to answer are: To determine the safety and tolerability of TUB-030 To determine the maximum tolerated dose of TUB-030 as a single drug given to patients with solid cancer Researchers will also compare doses of TUB-030 in two specific cancer types, in patients with head and neck cancer and patients with non-small cell lung cancer, to see if TUB-030 works to treat these two solid cancer types and to determine the best dose. Participants will: Receive drug TUB-030 every 3 weeks Visit the clinic once every 3 weeks for checkups and tests Answer patient reported outcome questionnaires about their symptoms
Who can join: Review the eligibility criteria below.
Location: Yale Cancer Center — New Haven, Connecticut
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 (18 Sites)
- Yale Cancer Center — New Haven, Connecticut
- University of Miami — Miami, Florida
- Massachusetts General Hospital — Boston, Massachusetts
- Dana Farber Cancer Institute — Boston, Massachusetts
- Mayo Clinic — Rochester, Minnesota
- Washington University — St Louis, Missouri
- Mount Sinai — New York, New York
- Cleveland Clinic — Cleveland, Ohio
- Ohio State University — Columbus, Ohio
- NEXT Oncology Austin — Austin, Texas
- NEXT Oncology - Dallas — Irving, Texas
- NEXT Oncology - San Antonio — San Antonio, Texas
- Fred Hutchinson Cancer Center — Seattle, Washington
- Princess Margaret — Toronto,
- Arensia Exploratory Medicine — Bucharest,
- Arensia Exploratory Medicine — Cluj-Napoca,
- Hospital Clinic Barcelona — Barcelona,
- Clinica Uni de Navara — Madrid,
📞 Contact the Study Coordinator
Phone: +491758005594
Email: ct-inquiries@tubulis.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 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 Solid Tumors
- A Study of FF-10850 Topotecan Liposome Injection in Advanced Solid Tumors Including Merkel Cell Carcinoma — Scottsdale, Arizona
- A Study of MRG002 in Patients with HER2-Positive Advanced Solid Tumors and Locally Advanced or Metastatic Gastric/Gastroesophageal Junction (GEJ) Cancer — Orange, California
- QTX3544 in Patients With Advanced Solid Tumors With KRAS G12V Mutations — Denver, Colorado
- A First-in-human Study to Learn How Safe the Study Drug BAY2965501 is, Find the Best Dose (Single Drug & Combination), How it Affects the Body, What Maximum Amount Can be Given, How it Moves Into, Through and Out of the Body, How it Acts on Different Tumors in Participants With Advanced Solid Tumors — Denver, Colorado
- A Phase 1 Dose-escalation Study of FF-10832 for Treatment of Solid Tumors Including Biliary Tract Cancer — Scottsdale, Arizona
- A Phase 1 Study of ATV-1601 in Patients With Advanced Cancer That Have AKT1 E17K Mutations — Los Angeles, California
Explore by condition: All Advanced Solid Tumors clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.