First in Human Study of TUB-030 in Patients With Advanced Solid Tumors
NCT ID: NCT06657222
Last Updated: 2025-09-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
130 participants
INTERVENTIONAL
2024-12-13
2028-12-31
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Phase 1: dose escalation
Drug TUB-030, administered by intravenous (IV) infusion
TUB-030
A complete treatment cycle is defined as 21 calendar days. TUB-030 will be administered as an intravenous (IV) solution on day 1 of each treatment cycle
Phase 2: dose optimization in NSCLC and HNSCC
Drug TUB-030, administered by intravenous (IV) infusion NSCLC Cohort: Patients will be randomized to receive one of two doses administered by IV infusion HNSCC Cohort: Patients will be randomized to receive one of two doses administered by IV infusion
TUB-030
A complete treatment cycle is defined as 21 calendar days. TUB-030 will be administered as an intravenous (IV) solution on day 1 of each treatment cycle
Interventions
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TUB-030
A complete treatment cycle is defined as 21 calendar days. TUB-030 will be administered as an intravenous (IV) solution on day 1 of each treatment cycle
Eligibility Criteria
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Inclusion Criteria
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
18 Years
ALL
No
Sponsors
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Tubulis GmbH
INDUSTRY
Responsible Party
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Principal Investigators
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Gunter Fingerle-Rowson, MD, PhD
Role: STUDY_DIRECTOR
Tubulis GmbH
Locations
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Yale Cancer Center
New Haven, Connecticut, United States
University of Miami
Miami, Florida, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Mayo Clinic
Rochester, Minnesota, United States
Washington University
St Louis, Missouri, United States
Mount Sinai
New York, New York, United States
Cleveland Clinic
Cleveland, Ohio, United States
Ohio State University
Columbus, Ohio, United States
NEXT Oncology Austin
Austin, Texas, United States
NEXT Oncology - Dallas
Irving, Texas, United States
NEXT Oncology - San Antonio
San Antonio, Texas, United States
Fred Hutchinson Cancer Center
Seattle, Washington, United States
Princess Margaret
Toronto, , Canada
Countries
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Central Contacts
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Other Identifiers
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5-STAR 1-01
Identifier Type: -
Identifier Source: org_study_id
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