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Testing TUB-030 for advanced solid tumors

A Multicenter FIH Dose Escalation and Optimization Phase I/IIa Trial to Investigate Safety, Tolerability, PK, and Efficacy of the 5T4 ADC TUB-030 in Patients With Advanced Solid Tumors (5-STAR 1-01)

Phase1; Phase2 Interventional Tubulis GmbH · NCT06657222

This study is testing a new drug called TUB-030 to see if it can safely help adults with advanced solid tumors, especially those with head and neck cancer or non-small cell lung cancer.

Quick facts

PhasePhase1; Phase2
Study typeInterventional
Enrollment250 (estimated)
Ages18 Years and up
SexAll
SponsorTubulis GmbH Industry-sponsored
Drugs / interventionschemotherapy, radiation
Locations16 sites (New Haven, Connecticut and 15 other locations)
Trial IDNCT06657222 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the safety and effectiveness of TUB-030 in treating advanced solid tumors in adults. It will determine the maximum tolerated dose of TUB-030 and assess its impact specifically on patients with head and neck cancer and non-small cell lung cancer. Participants will receive TUB-030 every three weeks and undergo regular check-ups and symptom assessments. The study focuses on understanding how well the drug works and its safety profile.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with advanced solid tumors who have stable disease after prior treatments.

Not a fit: Patients with untreated brain metastases or those who have not met the required timeframes since their last cancer treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors.

How similar studies have performed: Other studies have shown promise with similar approaches in targeting advanced solid tumors, but this specific drug is being tested for the first time in humans.

Eligibility criteria

Show full inclusion / exclusion 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:

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Where this trial is running

New Haven, Connecticut and 15 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Advanced Solid TumorsHNSCCSCLCNSCLCTNBC - Triple-Negative Breast CancerCRCHead and Neck Cancer
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.