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New drug TUB-030 targets Hard-to-Treat cancers in early trial

NCT ID NCT06657222

Disease control Sponsor: Tubulis GmbH Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Sep 11, 2026 · Updated 3 times

Summary

This trial tests a new drug called TUB-030 in adults with advanced solid tumors, including head and neck, lung, and breast cancers. The goal is to find the safest and most effective dose. Participants receive the drug every three weeks and are monitored for side effects and tumor response.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
TUB-030 (an antibody-drug conjugate targeting 5T4 protein)
What this could lead to
If successful, this could lead to a new treatment option for several advanced solid cancers that are hard to treat.
What could go wrong
This is an early-phase trial (Phase 1/2a) with a small number of participants, so the drug may not prove effective or may have unexpected side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 250 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2024

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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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Conditions

The condition(s) this trial relates to.

colorectal cancer colorectal carcinoma Head and Neck Neoplasms head and neck squamous cell carcinoma neoplasm non-small cell lung carcinoma small cell lung carcinoma Squamous Cell Carcinoma of Head and Neck triple-negative breast carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Advanced solid tumors CRC HNSCC NSCLC SCLC TNBC - triple-negative breast cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    20 sites in 5 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Arensia Exploratory Medicine

    RECRUITING

    Bucharest, Romania

  • Arensia Exploratory Medicine

    RECRUITING

    Cluj-Napoca, Romania

  • Cleveland Clinic

    RECRUITING

    Cleveland, Ohio, 44195, United States

  • Clinica Uni de Navara

    RECRUITING

    Madrid, Spain

  • Dana Farber Cancer Institute

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • Fred Hutchinson Cancer Center

    RECRUITING

    Seattle, Washington, 98109, United States

  • Hospital Clinic Barcelona

    RECRUITING

    Barcelona, Spain

  • Institut Curie

    RECRUITING

    Paris, 75005, France

  • Institut Gustave Roussy

    NOT_YET_RECRUITING

    Villejuif, 94805, France

  • Massachusetts General Hospital

    RECRUITING

    Boston, Massachusetts, 02114, United States

  • Mayo Clinic

    RECRUITING

    Rochester, Minnesota, 55905, United States

  • Mount Sinai

    RECRUITING

    New York, New York, 11766, United States

  • NEXT Oncology - Dallas

    RECRUITING

    Irving, Texas, 75039, United States

  • NEXT Oncology - San Antonio

    RECRUITING

    San Antonio, Texas, 78229, United States

  • NEXT Oncology Austin

    RECRUITING

    Austin, Texas, 78758, United States

  • Ohio State University

    RECRUITING

    Columbus, Ohio, 43210, United States

  • Princess Margaret

    RECRUITING

    Toronto, Canada

  • University of Miami

    RECRUITING

    Miami, Florida, 33136, United States

  • Washington University

    RECRUITING

    St Louis, Missouri, 63130, United States

  • Yale Cancer Center

    RECRUITING

    New Haven, Connecticut, 06510, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.