Advanced Solid Tumors study: TUB-030
Official title First in Human Study of TUB-030 in Patients With Advanced Solid Tumors
ClinicalTrials.gov ID: NCT06657222
What this study is testing
What is TUB-030?
TUB-030 is an investigational intravenous drug being studied as a potential treatment for advanced solid tumors.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study looks at how safe TUB‑030 is, finds the highest dose patients can tolerate, and compares two doses in head‑and‑neck and lung cancers.
- Who it's for
- Adults with advanced solid tumors such as head‑and‑neck cancer, non‑small cell lung cancer, triple‑negative breast cancer, colorectal cancer, and small‑cell lung cancer.
- What's involved
- Participants receive TUB‑030 every three weeks, go to the clinic every three weeks for check‑ups and tests, and fill out questionnaires about their symptoms.
- Time commitment
- The study continues until treatment ends, with clinic visits and drug doses every three weeks.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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.
See the full eligibility criteria
- 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...
- 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.
- 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...
- 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.
The study team makes the final eligibility decision.
Where it is enrolling
- New Haven, Connecticut, United States
- Miami, Florida, United States
- Boston, Massachusetts, United States
- Rochester, Minnesota, United States
- St Louis, Missouri, United States
- New York, New York, United States
- Cleveland, Ohio, United States
- Columbus, Ohio, United States
- Austin, Texas, United States
- Irving, Texas, United States
- San Antonio, Texas, United States
- Seattle, Washington, United States
- Toronto, Canada
- Paris, France
- Bucharest, Romania
- Cluj-Napoca, Romania
- Barcelona, Spain
- Madrid, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at New Haven, Connecticut, United States; Miami, Florida, United States; Boston, Massachusetts, United States; Rochester, Minnesota, United States; St Louis, Missouri, United States; New York, New York, United States and 12 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.