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.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 1/2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 250 (estimated)
- Sponsor
- Gilead Sciences · Industry
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About This Trial
The purpose of this multicenter, 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 participants 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…
Trial Locations
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Eligibility Criteria
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 n…
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