First in Human Study of TUB-030 in Patients With Advanced Solid Tumors

Recruiting now · Phase 1/Phase 2

Conditions studied: Advanced Solid Tumors, HNSCC, SCLC, NSCLC, TNBC - Triple-Negative Breast Cancer, CRC

In brief

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

Key facts

Study ID: NCT06657222
Run by: Tubulis GmbH
People needed: 250
Starts: 2024-12-13
Expected to finish: 2028-12-01
Last updated by the study team: 2026-05-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify 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 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.

Where it is running

Yale Cancer Center — New Haven, Connecticut, United States (enrolling)
University of Miami — Miami, Florida, United States (enrolling)
Dana Farber Cancer Institute — Boston, Massachusetts, United States (enrolling)
Mayo Clinic — Rochester, Minnesota, United States (enrolling)
Washington University — St Louis, Missouri, United States (enrolling)
Mount Sinai — New York, New York, United States (enrolling)
Cleveland Clinic — Cleveland, Ohio, United States (enrolling)
Ohio State University — Columbus, Ohio, United States (enrolling)
NEXT Oncology Austin — Austin, Texas, United States (enrolling)
NEXT Oncology - Dallas — Irving, Texas, United States (enrolling)
NEXT Oncology - San Antonio — San Antonio, Texas, United States (enrolling)
Fred Hutchinson Cancer Center — Seattle, Washington, United States (enrolling)
Princess Margaret — Toronto, Canada (enrolling)
Arensia Exploratory Medicine — Bucharest, Romania (enrolling)
Arensia Exploratory Medicine — Cluj-Napoca, Romania (enrolling)
Clinica Uni de Navara — Madrid, Spain (enrolling)

Full record on ClinicalTrials.gov

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