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First in Human Study of TUB-030 in Patients With Advanced Solid Tumors
NCT06657222 · Tubulis GmbH
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
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)
About this study
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 criteria
Inclusion Criteria:
1. Male or non-pregnant, non-breastfeeding female aged 18 years or older
2. Adequate organ function
3. Patients who received anti-cancer treatment including chemotherapy, biological therapy, endocrine therapy, PARP inhibitor, or other oral or investigational drugs must have had their last dose at least 4 weeks (6 weeks for nitrosourea, mitomycin-C) or 5 half-lives, whichever is shorter, before C1D1
4. AEs related to prior therapy, radiotherapy or surgical procedures must resolve to ≤grade 1.
5. For patients with known brain metastases, evidence of clinically stable disease post radiation therapy is required prior to enrollment.
6. For patients who underwent radiotherapy (≥ 30% of the bone marrow or wide field) to sites outside the brain, the final dose of radiation must have been administered ≥ 28 days prior to C1D1. For patients who underwent palliative radiotherapy (≤ 30% of the bone marrow or wide field) the final dose of radiation must have been administered ≥14 days prior to C1D1.
7. Radiologically measurable disease by RECIST v1.1, 4 weeks before C1D1, that can include a lesion in an irradiated field that shows progression according to RECIST v1.1 after irradiation.
8. Eastern Cooperative Oncology Group (ECOG) 0-1.
9. Have a life expectancy of \>12 weeks for disease-related mortality, as evaluated by the INV.
10. In the opinion of the INV, the patient must be able and willing to understand and give signed informed consent
11. Women of childbearing potential (WOCBP) who are sexually active with a non-sterilized partner must use at least 1 highly effective method of contraception (with a failure rate of 1% per year) from the time of screening and must agree to continue using such precautions until the end of exposure, plus 5 half-lives and 6 months add-on in the case of patients of childbearing potential Patients must agree to continue a highly effective contraceptive method, refrain from egg cell donation and breastfeeding while on study treatment and for 5 half-lives plus 6 months after the last dose of study treatment.
12. Males must use an effective barrier method of contraception without interruption if the patient is sexually active with an WOCBP until the end of exposure, 5 half-lives plus 6 months add-on after the end of treatment. In addition, their female partners who are WOCBP should agree to use 1 highly effective barrier method of contraception at the same time. Male patients should refrain from donating sperm during study participation and for 6 months after the last dose of the study drug.
Exclusion Criteria:
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Study design
Enrollment target: 250 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2024-12-13
Estimated completion: 2028-12
Last updated: 2026-03-03
Interventions
Drug: TUB-030
Primary outcomes
- • Determination of MTD (From enrollment until 30 days after last study drug)
Sponsor
Tubulis GmbH · industry
Contacts & investigators
ContactTubulis Clinical Trial Inquiries · contact · ct-inquiries@tubulis.com · +491758005594
InvestigatorYariv Houvras, MD, PhD · study_director, Tubulis GmbH
All locations (16)
Yale Cancer CenterRecruiting
New Haven, Connecticut, United States
University of MiamiRecruiting
Miami, Florida, United States
Dana Farber Cancer InstituteRecruiting
Boston, Massachusetts, United States
Mayo ClinicRecruiting
Rochester, Minnesota, United States
Washington UniversityRecruiting
St Louis, Missouri, United States
Mount SinaiRecruiting
New York, New York, United States
Cleveland ClinicRecruiting
Cleveland, Ohio, United States
Ohio State UniversityRecruiting
Columbus, Ohio, United States
NEXT Oncology AustinRecruiting
Austin, Texas, United States
NEXT Oncology - DallasRecruiting
Irving, Texas, United States
NEXT Oncology - San AntonioRecruiting
San Antonio, Texas, United States
Fred Hutchinson Cancer CenterRecruiting
Seattle, Washington, United States
Princess MargaretRecruiting
Toronto, Canada
Arensia Exploratory MedicineRecruiting
Bucharest, Romania
Arensia Exploratory MedicineRecruiting
Cluj-Napoca, Romania
Clinica Uni de NavaraRecruiting
Madrid, Spain