First in Human Study of TUB-030 in Patients With Advanced Solid Tumors
Condition(s) studied
Investigational drug(s) / intervention(s)
TUB-030: A complete treatment cycle is defined as 21 calendar days. TUB-030 will be administered as an intravenous (IV) solution on day 1 of each treatment cycle
Study summary
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
Eligibility
Primary outcome measure(s)
- Determination of MTD — From enrollment until 30 days after last study drug
The highest dose is defined at which no more than 1 of 3 patients have had a Dose Limiting Toxicity (DLT) according to NCI CTCAE V5.0 criteria
Trial sites (20)
| Facility | City | Region | Status |
|---|---|---|---|
| Yale Cancer Center | New Haven | Connecticut | Recruiting |
| University of Miami | Miami | Florida | Recruiting |
| Massachusetts General Hospital | Boston | Massachusetts | Recruiting |
| Dana Farber Cancer Institute | Boston | Massachusetts | Recruiting |
| Mayo Clinic | Rochester | Minnesota | Recruiting |
| Washington University | St Louis | Missouri | Recruiting |
| Mount Sinai | New York | New York | Recruiting |
| Cleveland Clinic | Cleveland | Ohio | Recruiting |
| Ohio State University | Columbus | Ohio | Recruiting |
| NEXT Oncology Austin | Austin | Texas | Recruiting |
| NEXT Oncology - Dallas | Irving | Texas | Recruiting |
| NEXT Oncology - San Antonio | San Antonio | Texas | Recruiting |
| Fred Hutchinson Cancer Center | Seattle | Washington | Recruiting |
| Princess Margaret | Toronto | Canada | Recruiting |
| Institut Curie | Paris | France | Recruiting |
| Institut Gustave Roussy | Villejuif | France | Not Yet Recruiting |
| Arensia Exploratory Medicine | Bucharest | Romania | Recruiting |
| Arensia Exploratory Medicine | Cluj-Napoca | Romania | Recruiting |
| Hospital Clinic Barcelona | Barcelona | Spain | Recruiting |
| Clinica Uni de Navara | Madrid | Spain | Recruiting |
More Gilead Sciences trials in the USA
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06657222 on ClinicalTrials.gov ↗ ← All trials in the USA