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A Multicenter First-in-Human Dose Escalation and Optimization Trial to Investigate Safety, Tolerability, and Effectiveness of the 5T4 ADC TUB-030 in Patients With Advanced Solid Tumors
Led by Tubulis GmbH · Updated on 2026-05-27
250
Participants Needed
16
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Researchers are evaluating the drug TUB-030 to treat advanced solid tumors in adults, including head and neck cancer and non-small cell lung cancer. This clinical trial aims to determine the safety, tolerability, and best dose of TUB-030 given as a single drug. The study also explores how well the drug works in these cancer types and finds the maximum tolerated dose. Participants will receive TUB-030 through intravenous (IV) infusion every 3 weeks. The study has two parts: a dose escalation phase and a dose optimization phase where patients with non-small cell lung cancer or head and neck cancer are randomly assigned to one of two doses. Each treatment cycle lasts 21 days, with the drug given on day 1. The trial evaluates different doses to find the best balance of safety and potential effect. During the study, participants will visit the clinic every 3 weeks for checkups and tests. Researchers will collect data on adverse events, drug levels in the body, and immune responses from enrollment until 30 days after the last dose. Participants will also complete questionnaires about their symptoms. The main outcome measured is the maximum tolerated dose, while other outcomes include safety, how the drug moves through the body, and its effectiveness. The total study duration depends on treatment cycles and follow-up.
CONDITIONS
Brief Title
First in Human Study of TUB-030 in Patients With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or non-pregnant, non-breastfeeding female aged 18 years or older
- Adequate organ function
- Last anti-cancer treatment at least 4 weeks before starting study drug (6 weeks for nitrosourea or mitomycin-C), or 5 half-lives, whichever is shorter
- Side effects from prior therapy must have resolved to mild or less (grade 1 or lower)
- Stable brain metastases after radiation therapy if present
- Last radiation outside the brain must be at least 28 days before study drug start if extensive, or 14 days if palliative
- Radiologically measurable disease by RECIST v1.1 within 4 weeks before study drug start
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Life expectancy greater than 12 weeks as judged by the investigator
- Able and willing to understand and sign informed consent
- Women of childbearing potential must use highly effective contraception during and for 5 half-lives plus 6 months after treatment
- Men must use effective barrier contraception during and for 5 half-lives plus 6 months after treatment, and refrain from sperm donation during this time
You will not qualify if you...
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 21-day cycles until disease progression or discontinuation
Participants receive the drug TUB-030 administered by intravenous infusion on day 1 of each 21-day treatment cycle.
1 visit per treatment cycle (in-person)
Duration - 30 days after last study drug
Participants are monitored for safety and treatment effects for 30 days after the last dose of study drug.
Approximately 1 to 2 visits (in-person)
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
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5
Washington University
St Louis, Missouri, United States, 63130
Actively Recruiting
6
Mount Sinai
New York, New York, United States, 11766
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7
Cleveland Clinic
Cleveland, Ohio, United States, 44195
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8
Ohio State University
Columbus, Ohio, United States, 43210
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9
NEXT Oncology Austin
Austin, Texas, United States, 78758
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10
NEXT Oncology - Dallas
Irving, Texas, United States, 75039
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11
NEXT Oncology - San Antonio
San Antonio, Texas, United States, 78229
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12
Fred Hutchinson Cancer Center
Seattle, Washington, United States, 98109
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13
Princess Margaret
Toronto, Canada
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14
Arensia Exploratory Medicine
Bucharest, Romania
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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
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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