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First in Human Study of TUB-030 in Patients With Advanced Solid Tumors
Trial Status: active
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 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:
-
Additional locations may be listed on ClinicalTrials.gov for NCT06657222.
Locations matching your search criteria
United States
Connecticut
New Haven
Yale University
Status: Active
Name Not Available
Trumbull
Smilow Cancer Hospital Care Center-Trumbull
Status: Active
Name Not Available
Florida
Miami
University of Miami Miller School of Medicine-Sylvester Cancer Center
Status: Active
Name Not Available
Massachusetts
Boston
Dana-Farber Cancer Institute
Status: Active
Name Not Available
Brigham and Women's Hospital
Status: Active
Name Not Available
Minnesota
Rochester
Mayo Clinic in Rochester
Status: Active
Name Not Available
Missouri
Saint Louis
Siteman Cancer Center at Washington University
Status: Active
Name Not Available
New York
New York
Icahn School of Medicine at Mount Sinai
Status: Active
Name Not Available
Ohio
Cleveland
Case Comprehensive Cancer Center
Status: Active
Name Not Available
Columbus
Ohio State University Comprehensive Cancer Center
Status: Active
Name Not Available
Washington
Seattle
Fred Hutch/University of Washington/Seattle Children's Cancer Consortium