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

Description

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.

Conditions

Ovarian Cancer, Non-small Cell Lung Cancer

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Study Overview

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Study Details

Study overview

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.

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)

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

Condition
Ovarian Cancer
Intervention / Treatment

-

Contacts and Locations

Cincinnati

Christ Hospital, Cincinnati, Ohio, United States, 45219

Fairfax

Next Oncology Virginia, Fairfax, Virginia, United States, 22031

Oklahoma

OU Health Stephenson Cancer Center, Oklahoma, United States,

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

    Ages Eligible for Study

    18 Years to

    Sexes Eligible for Study

    ALL

    Accepts Healthy Volunteers

    No

    Collaborators and Investigators

    Tubulis GmbH,

    Guenter Fingerle-Rowson, MD, PhD, STUDY_DIRECTOR, Tubulis GmbH

    Study Record Dates

    2027-01