RecruitingPhase 1Phase 2NCT06303505

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)


Sponsor

Tubulis GmbH

Enrollment

250 participants

Start Date

Jun 12, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This is a first-in-human study testing the safety and early effectiveness of a new experimental drug called TUB-040 in people with two types of hard-to-treat cancers: platinum-resistant ovarian cancer, or non-small cell lung cancer (adenocarcinoma type) that has returned after treatment. TUB-040 is an antibody-drug conjugate — a targeted molecule that delivers a toxic payload directly to cancer cells. **You may be eligible if...** - You are 18 years or older - You have platinum-resistant ovarian cancer or relapsed/refractory lung adenocarcinoma - Your cancer can be measured on imaging and is not curable with available treatments - You are in good general health (ECOG score 0–1) - Your expected survival from the disease is more than 12 weeks - You have tumor tissue available for biomarker testing **You may NOT be eligible if...** - You still have standard treatments available that could benefit you - You have serious heart, kidney, liver, or lung conditions - You are pregnant or breastfeeding - You have had certain recent prior treatments that would interfere with this drug Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTUB-040

A complete treatment cycle is defined as 21 calendar days. TUB-040 will be administered as an intravenous (IV) solution on day 1 of each treatment cycle


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

Arensia Exploratory Medicine

Cluj-Napoca, Romania

Clínica universidad de Navarra

Madrid, Spain

NEXT Oncology Madrid

Madrid, Spain

Arensia Exploratory Medicine

Kyiv, Ukraine

Guy's Hospital

London, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT06303505


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