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

Launched by TUBULIS GMBH · Oct 22, 2024

Keywords

ClinConnect Summary

This clinical trial is testing a new drug called TUB-030 to see if it can effectively treat advanced solid tumors, including types like head and neck cancer, lung cancer, and triple-negative breast cancer. The main goals are to find out how safe TUB-030 is and to determine the highest dose that patients can tolerate. Some participants will receive TUB-030 every three weeks, and the study will also gather information on how this drug affects patients’ symptoms and overall health.

To be eligible for this trial, participants need to be adults aged 18 or older with certain types of advanced cancer that has not responded to previous treatments. They should have stable organ function and meet specific health criteria. Throughout the study, participants will visit the clinic every three weeks for checkups and tests. It’s important to note that women who can become pregnant must use effective birth control during the study and for a period after treatment. This trial is currently recruiting participants, and it's a great opportunity for those looking for new treatment options.

Gender

ALL

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.
• Exclusion Criteria:
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