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TUB-040 / Ovarian Cancer / Non Small Cell Lung Cancer · Phase 1/2 Trial
ClinicalTrials.gov · August 17, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a first-in-human, open-label, multicentric Phase 1/2 trial of TUB-040, a NaPi2b-targeted antibody-drug conjugate delivering topoisomerase I inhibitor, registered but not yet reporting results. The study is recruiting to establish maximum tolerated dose and preliminary efficacy in ovarian and non-small-cell lung cancers.
Phase 1/2, Interventional, Non Randomized, Sequential, Open label, Treatment purpose. Ovarian Cancer, Non-small Cell Lung Cancer; age from 18 Years. Intervention: Platinum resistant ovarian cancer; Non small cell lung cancer-adenocarcinoma; Platinum resistant ovarian cancer in combination with Bevac…. Compared with: In dose optimization phase, at least two dose levels of TUB-040 are compared; no external comparator arm specified. n = 250. 16 sites across 7 countries.
This is a first-in-human, open-label, multicentric Phase 1/2 trial of TUB-040, a NaPi2b-targeted antibody-drug conjugate delivering topoisomerase I inhibitor, registered but not yet reporting results. The study is recruiting to establish maximum tolerated dose and preliminary efficacy in ovarian and non-small-cell lung cancers.
This is a registry record with no results posted; outcomes, safety profile, and efficacy are unknown. No effect sizes, response rates, adverse event frequencies, or pharmacokinetic parameters are reported.
No results are available from this registry record. Clinicians should monitor for publication of safety, pharmacokinetic, and preliminary efficacy data once the study is complete.
This is a first-in-human Phase 1/2 study still in recruitment with no results posted; it aims to establish safety, pharmacokinetics, and preliminary efficacy of a novel antibody-drug conjugate.
As stated by the source record.
Quoted from the source exactly as published.
No results are available from this registry record. Clinicians should monitor for publication of safety, pharmacokinetic, and preliminary efficacy data once the study is complete.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT06303505). This is a study registration, not published results. Lead sponsor: Tubulis GmbH. Recruitment status: RECRUITING. Phase: PHASE1, PHASE2. Study type: INTERVENTIONAL. Enrollment: 250 participants (ESTIMATED). Conditions: Ovarian Cancer, Non-small Cell Lung Cancer. Interventions: DRUG: TUB-040. Primary outcome measures: Determination of MTD , From enrollment until 30 days after last study drug. Brief 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.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.