Actively Recruiting
First in Human Study of TUB-030 in Patients With Advanced Solid Tumors
Led by Tubulis GmbH · Updated on 2026-03-03
250
Participants Needed
16
Research Sites
207 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
First in Human Study of TUB-030 in Patients With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Male or non-pregnant, non-breastfeeding female
- Adequate organ function
- Last dose of anti-cancer treatment at least 4 weeks ago (6 weeks for nitrosourea, mitomycin-C) or 5 half-lives, whichever is shorter
- Any side effects from prior therapy, radiotherapy, or surgery resolved to grade 1 or less
- Clinically stable brain metastases after radiation therapy if present
- Final dose of radiotherapy outside the brain at least 28 days before first treatment day; for palliative radiotherapy, at least 14 days prior
- Measurable disease by RECIST v1.1 within 4 weeks before first treatment day
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Life expectancy greater than 12 weeks
- Able and willing to give signed informed consent
- Women of childbearing potential using highly effective contraception and agreeing to continue during and after treatment
- Men using effective barrier contraception during and after treatment and agreeing to avoid sperm donation
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
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Trial Site Locations
Total: 16 locations
1
Yale Cancer Center
New Haven, Connecticut, United States, 06510
Actively Recruiting
2
University of Miami
Miami, Florida, United States, 33136
Actively Recruiting
3
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
4
Mayo Clinic
Rochester, Minnesota, United States, 55905
Actively Recruiting
5
Washington University
St Louis, Missouri, United States, 63130
Actively Recruiting
6
Mount Sinai
New York, New York, United States, 11766
Actively Recruiting
7
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
8
Ohio State University
Columbus, Ohio, United States, 43210
Actively Recruiting
9
NEXT Oncology Austin
Austin, Texas, United States, 78758
Actively Recruiting
10
NEXT Oncology - Dallas
Irving, Texas, United States, 75039
Actively Recruiting
11
NEXT Oncology - San Antonio
San Antonio, Texas, United States, 78229
Actively Recruiting
12
Fred Hutchinson Cancer Center
Seattle, Washington, United States, 98109
Actively Recruiting
13
Princess Margaret
Toronto, Canada
Actively Recruiting
14
Arensia Exploratory Medicine
Bucharest, Romania
Actively Recruiting
15
Arensia Exploratory Medicine
Cluj-Napoca, Romania
Actively Recruiting
16
Clinica Uni de Navara
Madrid, Spain
Actively Recruiting
Research Team
T
Tubulis Clinical Trial Inquiries
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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