NCT06657222 First in Human Study of TUB-030 in Patients With Advanced Solid Tumors
| NCT ID | NCT06657222 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Tubulis GmbH |
| Condition | Advanced Solid Tumors |
| Study Type | INTERVENTIONAL |
| Enrollment | 250 participants |
| Start Date | 2024-12-13 |
| Primary Completion | 2028-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 250 participants in total. It began in 2024-12-13 with a primary completion date of 2028-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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. 12. 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. Exclusion Criteria: \-
Contact & Investigator
Yariv Houvras, MD, PhD
STUDY DIRECTOR
Tubulis GmbH
Frequently Asked Questions
Who can join the NCT06657222 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Advanced Solid Tumors. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06657222 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06657222 currently recruiting?
Yes, NCT06657222 is actively recruiting participants. Contact the research team at ct-inquiries@tubulis.com for enrollment information.
Where is the NCT06657222 trial being conducted?
This trial is being conducted at New Haven, United States, Miami, United States, Boston, United States, Rochester, United States and 11 additional locations.
Who is sponsoring the NCT06657222 clinical trial?
NCT06657222 is sponsored by Tubulis GmbH. The principal investigator is Yariv Houvras, MD, PhD at Tubulis GmbH. The trial plans to enroll 250 participants.