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

Recruiting Phase 1 Phase 2 Interventional Study
Ovarian Cancer Non-small Cell Lung Cancer
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
250 (estimated)
Sponsor
Tubulis GmbH · Industry
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About This Trial
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 st…
Trial Locations
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Eligibility Criteria
Inclusion Criteria (for all patients) 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 den…
Contacts

Tubulis Clinical Trial Inquiries

+ 49 175 800 5594

ct-inquiries@tubulis.com

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