First in Human Study of TUB-030 in Patients With Advanced Solid Tumors
Public ClinicalTrials.gov record NCT06657222. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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
Study identification
- NCT ID
- NCT06657222
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 250 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 12, 2024
- Primary completion
- Nov 30, 2028
- Completion
- Nov 30, 2028
- Last update posted
- Sep 10, 2026
2024 – 2028
United States locations
- U.S. sites
- 13
- U.S. states
- 9
- U.S. cities
- 12
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Yale Cancer Center | New Haven | Connecticut | 06510 | Recruiting |
| University of Miami | Miami | Florida | 33136 | Recruiting |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | Recruiting |
| Dana Farber Cancer Institute | Boston | Massachusetts | 02215 | Recruiting |
| Mayo Clinic | Rochester | Minnesota | 55905 | Recruiting |
| Washington University | St Louis | Missouri | 63130 | Recruiting |
| Mount Sinai | New York | New York | 11766 | Recruiting |
| Cleveland Clinic | Cleveland | Ohio | 44195 | Recruiting |
| Ohio State University | Columbus | Ohio | 43210 | Recruiting |
| NEXT Oncology Austin | Austin | Texas | 78758 | Recruiting |
| NEXT Oncology - Dallas | Irving | Texas | 75039 | Recruiting |
| NEXT Oncology - San Antonio | San Antonio | Texas | 78229 | Recruiting |
| Fred Hutchinson Cancer Center | Seattle | Washington | 98109 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 7 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06657222, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 10, 2026 · Synced Sep 12, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06657222 live on ClinicalTrials.gov.