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FiH Study to Investigate Safety, PK and Efficacy of the NaPi2b ADC TUB-040 in Patients With PROC or r/r Adenocarcinoma NSCLC | Clinical Trials | Clareo Health

RECRUITINGPHASE1/PHASE2

FiH Study to Investigate Safety, PK and Efficacy of the NaPi2b ADC TUB-040 in Patients With PROC or r/r Adenocarcinoma NSCLC

A First-in-human Dose Escalation and Optimization Phase I/IIa Study to Investigate Safety, Tolerability, PK, and Efficacy of the NaPi2b ADC TUB-040 in Patients With Platinum-resistant High-grade Ovarian Cancer (PROC) or r/r Adenocarcinoma Non-small Cell Lung Cancer (NSCLC)

NCT06303505•Tubulis GmbH

View on ClinicalTrials.gov

Summary

The purpose of this multicentric, open label trial (NAPISTAR 1-01) is to evaluate the safety/tolerability, pharmacokinetics and preliminary efficacy of TUB-040 and to find the best dose of TUB-040 in patients with ovarian cancer and Non Small Cell Lung Cancer. TUB-040 is an antibody-drug-conjugate which delivers a topoisomerase I inhibitor to tumor cells which overexpress the target NaPi2b. The study consists of two parts: In dose escalation, ovarian cancer patients and lung cancer patients receive increasing doses of TUB-040 until the maximal tolerated dose is found. In dose optimization, at least two doses are compared with each other to determine which dose is optimal for patients. TUB-040 is given IV every 3 weeks until the disease progresses or the patient has to stop due to side effects.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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. Patients 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. Radiologically measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, that includes at least 1 lesion not previously irradiated.
•5. Eastern Cooperative Oncology Group (ECOG) 0-1.
•6. Have a life expectancy of more than 12 weeks for disease-related mortality, as evaluated by the INV.
•7. Patients must be willing to sign an archival tissue release form for research purposes and determination of biomarker (eg NaPi2b) expression.
•8. Patients must be willing to undergo a non-contrast high resolution computed tomography (HRCT) of the thorax scan and pulmonary function testing (PFT) at screening.
•9. Adequate organ function
•10. 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).
+8 more criteria

Exclusion Criteria

•1. The patient 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, including ADCs with deruxtecan, exatecan or camptothecan as a payload.
•3. Disease that is refractory to topoisomerase-I inhibitors, defined as progression during or within 6 months of the last infusion.
•4. Patients 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.
•5. Patients with spinal cord compression or active central nervous system disease.
•6. Prior radiotherapy \<2 weeks from trial inclusion.
•7. Major surgery within 21 days prior to signing the ICF, unless the patient is recovered at that time.
•8. Has a history of non-infectious ILD/pneumonitis/radiation pneumonitis that required steroids or has current ILD/pneumonitis.
•9. Has an oxygen saturation of \<93% on room air at rest.
•10. Has a forced vital capacity of \<60% and diffusing capacity of the lung for carbon monoxide \<70%.
+9 more criteria

Locations (15)

The University of Alabama

Birmingham, Alabama, United States

Mount Sinai

New York, New York, United States

Christ Hospital

Cincinnati, Ohio, United States

Ohio State University

Columbus, Ohio, United States

OU Health Stephenson Cancer Center

Oklahoma City, Oklahoma, United States

Next Oncology Dallas

Irving, Texas, United States

Next Oncology Virginia

Fairfax, Virginia, United States

UZ Leuven

Leuven, Belgium

Charité Universitätsmedizin Berlin

Berlin, Germany

University Hospital Cologne Department of Internal Medicine I

Cologne, Germany

Key Dates

Start Date

June 12, 2024

Primary Completion Date

December 1, 2027

Completion Date

December 1, 2027

Last Updated

March 3, 2026

Enrollment

250

ESTIMATED participants

Conditions

Ovarian CancerNon-small Cell Lung Cancer

Interventions

TUB-040

DRUG

Contacts

Tubulis Clinical Trial Inquiries

CONTACT

+ 49 175 800 5594 ct-inquiries@tubulis.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 3, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

FiH Study to Investigate Safety, PK and Efficacy of the NaPi2b ADC TUB-040 in Patients With PROC or r/r Adenocarcinoma NSCLC

Inclusion Criteria

Exclusion Criteria

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