First study of TUB-030 in adults with advanced solid tumors
Tests the drug TUB-030 in adults with advanced solid cancers.
Plain-language title generated from the registry record
Registry title: First in Human Study of TUB-030 in Patients With Advanced Solid Tumors
Key facts
- Where
- Barcelona and Madrid, SpainSee the 2 sites
- Phase
- Phase 1/2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with advanced solid tumors who have measurable disease and are in fairly good physical shape. It tests the new drug TUB-030 for safety and dose.
- Age
- 18 years or older
- Sex
- Men and women; women must not be pregnant or breastfeeding
- Disease stage
- Advanced solid tumors with disease that can be measured on scans (RECIST v1.1)
- Earlier treatment
- Last anti-cancer treatment at least 4 weeks before the first dose (6 weeks for nitrosourea, mitomycin-C), or 5 half-lives if shorter. Side effects from earlier treatment must have settled to grade 1 or less.
Main reasons for not taking part
- Pregnant or breastfeeding women
- Brain metastases that are not clinically stable after radiation
- Radiotherapy too close to the first dose (14 or 28 days, depending on the area treated)
- Expected to live 12 weeks or less
- ECOG performance status higher than 1
Read by machine on 12 November 2026.
Where in Spain
- Hospital Clinic de BarcelonaBarcelona, SpainTaking people
- Clinica Universidad de NavarraMadrid, SpainTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Gilead Sciences
- Trial code
- NCT06657222EU 2025-522517-35-00
- Record updated
- 11 September 2026
- Original description
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:Read full original descriptionShow less
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)
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
Inclusion: Male or non-pregnant, non-breastfeeding female aged 18 years or older; Adequate organ function; 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; AEs related to prior therapy, radiotherapy or surgical procedures must resolve to ≤grade 1; For patients with known brain metastases, evidence of clinically stable disease post radiation therapy is required prior to enrollment; 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; 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; Eastern Cooperative Oncology Group (ECOG) 0-1; Have a life expectancy of >12 weeks for disease-related mortality, as evaluated by the INV; In the opinion of the INV, the patient must be able and willing to understand and give signed informed consent; 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; 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: -.