New smart drug targets Hard-to-Treat cancers

NCT ID NCT06303505

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

First seen Jun 26, 2026 · Last updated Sep 15, 2026 · Updated 8 times

Summary

This study tests a new drug called TUB-040 for people with ovarian cancer that no longer responds to platinum chemotherapy, or with a type of lung cancer that has come back. TUB-040 is an antibody-drug conjugate, meaning it delivers a powerful chemotherapy directly to cancer cells that have a specific marker (NaPi2b). The trial has two parts: first, finding the safest dose, and then comparing doses to see which works best. Participants receive the drug intravenously every three weeks.

What this could mean

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

Active substance: TUB-040 (an antibody-drug conjugate that delivers a chemotherapy drug directly to cancer cells)
What this could lead to: If successful, this could provide a new treatment option for patients with hard-to-treat ovarian or lung cancer who have run out of standard therapies.
What could go wrong: This is an early-phase trial (Phase 1/2a) with a small number of patients, so the drug may not work or may cause significant side effects. The cancer types are aggressive and resistant to current treatments, making success uncertain.

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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

Jun 2024

Expected to finish

Dec 2027

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.

Key Inclusion Criteria (for all phases) 1. Male or non-pregnant, non-breastfeeding female, age 18 years or older at the date of consent. 2. Disease not amenable to curative intent treatment. 3. Participants have exhausted the standard of care treatment (SoC) with expected survival benefit and are not denied SoC with expected survival benefit by participating in the trial. 4. Participants with previous systemic topoisomerase I inhibitor treatment (e.g., Topotecan) are allowed in the study. 5. Radiologically measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by the INV. 6. Eastern Cooperative Oncology Group (ECOG) 0-1. 7. Have a life expectancy of more than 12 weeks for disease-related mortality, as evaluated by the INV. 8. Participants must be willing to sign an archival tissue release form for research purposes and determination of biomarker expression. 9. Participants must be willing to undergo a non-contrast high resolution computed tomography (HRCT) of the thorax scan and pulmonary function testing (PFT) at screening. 10. Adequate organ function 11. Resolution of all acute toxic effects of prior therapy or surgical procedures to ≤grade 1 (except alopecia, hyperpigmentation, or discoloration (incl. vitiligo) of the skin and nails, stable immune-related toxicity such as hypothyroidism on hormone replacement, adrenal insufficiency on ≤10 mg daily prednisone \[or equivalent\], chronic grade 2 peripheral sensory neuropathy after prior taxane therapy or anticancer treatment such as but not limited to IOs). 12. Participants of childbearing potential (FCBP) who are sexually active with a non-sterilized partner must use at least one highly effective method of contraception 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 participants assigned female at birth. 13. In the opinion of the investigator, the participant must be able to understand, give written informed consent, and comply with all study-related procedures, medication use, and evaluations. 14. The participant must not have a history of non-compliance with medical regimens or be considered potentially unreliable and/or uncooperative. 15. The participant must be willing to sign and date the informed consent form (ICF) Key Exclusion Criteria (for all phases) 1. The participant is pregnant, lactating or breastfeeding or has a positive serum pregnancy test during the screening period. 2. History of hypersensitivity to exatecan or excipients of the TUB-040 formulation. 3. Participants are not allowed to participate in interventional clinical studies either concurrently or within the previous 28 days or within 5 half-lives of any investigational pharmacologic agents or imaging materials, including dyes, investigational surgical techniques, or devices. 4. Participants with spinal cord compression or active central nervous system disease, and/or carcinomatous meningitis. 5. Prior radiotherapy \<2 weeks from trial inclusion. 6. Major surgery within 21 days prior to signing the ICF, unless the participant is recovered at that time. 7. Has a history of non-infectious ILD/pneumonitis/radiation pneumonitis that required steroids or has current ILD/pneumonitis. 8. Has an oxygen saturation of \<93% on room air at rest. 9. Has a QTcF \>470 ms 10. History of nephrotic syndrome 11. Active corneal disease, or history of corneal disease within 12 months prior to enrollment. 12. Active, uncontrolled or severe impairment of the urogenital, renal, hepatobiliary, cardiovascular, gastrointestinal, neurologic, or hematopoietic systems which, in the opinion of the investigator, would predispose the participant to the development of complications from the administration of protocol therapy. 13. History of another malignancy with ongoing treatment or not yet free from disease for 2 years, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or other malignancy with a similar expected curative outcome. 14. Documented other concurrent non-malignant comorbidities such as unstable or uncontrolled pectoral angina, myocardial infarction during the last 6 months, valvular heart disease that requires treatment, acute myocarditis, or congestive heart failure (CHF) (New York Heart Association III or IV). 15. Any anti-tumor chemotherapy, systemic anti-cancer therapy, radiotherapy (except for local radiation therapy of lesions that may cause imminent complications), hormonal therapy, immunotherapy, or corticoid therapy. 16. Concurrent use of strong inhibitors or strong inducers of CYP3A4 17. Live vaccines within 30 days prior to study entry. 18. Participants with acute or chronic infections such as: 1. Participants who are HBsAg positive are eligible if they have received HBV anti-viral therapy for at least 4 weeks and have an undetectable HBV viral load prior to randomization. 2. Participants with a history of HCV infection are eligible if HCV viral load is undetectable at screening. 3. HIV infected participants must be on anti-retroviral therapy (ART) and have a well-controlled HIV infection/disease 4. Any other known unresolved and active bacterial, viral, fungal, mycobacterial, or other infection at screening. 5. History of severe and recurrent infections per INV judgment. 6. History of progressive multifocal leukoencephalopathy Note: Other protocol defined Inclusion/Exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

lung adenocarcinoma non-small cell lung carcinoma ovarian cancer ovarian carcinoma

As listed by the trial registrant

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

Non-small cell lung cancer Ovarian cancer

How to take part

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

The places running it

27 sites in 6 countries. The list below names each one and where it is.
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 ↗
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

Allegheny Singer
NOT_YET_RECRUITING

Pittsburgh, Pennsylvania, 15212, United States
Arensia Exploratory Medicine
RECRUITING

Cluj-Napoca, Romania
Arensia Exploratory Medicine
ACTIVE_NOT_RECRUITING

Kyiv, Ukraine
Asante / Heimann Cancer Center
NOT_YET_RECRUITING

Medford, Oregon, 97504, United States
Charité Universitätsmedizin Berlin
RECRUITING

Berlin, 10117, Germany
Christ Hospital
RECRUITING

Cincinnati, Ohio, 45219, United States
Clínica universidad de Navarra
RECRUITING

Madrid, 28027, Spain
Dana-Farber Cancer Institute
NOT_YET_RECRUITING

Boston, Massachusetts, 02215, United States
Emory University
NOT_YET_RECRUITING

Atlanta, Georgia, 30322, United States
Guy's Hospital
ACTIVE_NOT_RECRUITING

London, SE1 9RT, United Kingdom
Inova Schar Cancer Institute
NOT_YET_RECRUITING

Fairfax, Virginia, 22031, United States
Mount Sinai
RECRUITING

New York, New York, 10011, United States
NEXT Oncology Madrid
RECRUITING

Madrid, 28223, Spain
Next Oncology Dallas
RECRUITING

Irving, Texas, 75039, United States
Next Oncology Virginia
RECRUITING

Fairfax, Virginia, 22031, United States
Norton Cancer Institute Research
NOT_YET_RECRUITING

Louisville, Kentucky, 40217, United States
OU Health Stephenson Cancer Center
RECRUITING

Oklahoma City, Oklahoma, 73104, United States
Ohio State University
RECRUITING

Columbus, Ohio, 43210#, United States
Providence Sacred Heart Medical Center
NOT_YET_RECRUITING

Spokane, Washington, 99204, United States
Puerto Rico Cancer Clinical Trials
NOT_YET_RECRUITING

San Juan, 00927, Puerto Rico
START Mountain Region
RECRUITING

West Valley City, Utah, 84119, United States
START New Jersey East Brunswick
RECRUITING

East Brunswick, New Jersey, 08816, United States
Spartanburg Regional
NOT_YET_RECRUITING

Spartanburg, South Carolina, 29303, United States
Start Dfw
RECRUITING

Fort Worth, Texas, 76104, United States
The University of Alabama
RECRUITING

Birmingham, Alabama, 35294, United States
Tufts
NOT_YET_RECRUITING

Boston, Massachusetts, 02111, United States
UZ Leuven
RECRUITING

Leuven, Belgium, 3000, Belgium
University Hospital Cologne Department of Internal Medicine I
RECRUITING

Cologne, 50937, Germany
Yale Cancer Center
NOT_YET_RECRUITING

New Haven, Connecticut, 06510, United States

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