OncoMatch/Clinical Trials/NCT06303505
FiH Study to Investigate Safety, PK and Efficacy of the NaPi2b ADC TUB-040 in Patients With PROC or r/r Adenocarcinoma NSCLC
Is NCT06303505 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies TUB-040 for ovarian cancer.
Treatment: TUB-040 — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Ovarian Cancer
Non-Small Cell Lung Carcinoma
Biomarker criteria
Required: SLC34A2 expression
determination of biomarker (eg NaPi2b) expression
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: standard of care
Patients have exhausted the standard of care treatment (SoC) with expected survival benefit
Cannot have received: topoisomerase-I inhibitor
Disease that is refractory to topoisomerase-I inhibitors, defined as progression during or within 6 months of the last infusion.
Cannot have received: radiotherapy
Exception: prior radiotherapy <2 weeks from trial inclusion
Prior radiotherapy <2 weeks from trial inclusion.
Cannot have received: major surgery
Exception: within 21 days prior to signing the ICF, unless recovered
Major surgery within 21 days prior to signing the ICF, unless the patient is recovered at that time.
Cannot have received: ADC with deruxtecan, exatecan or camptothecan payload
History of hypersensitivity to exatecan or excipients of the TUB-040 formulation, including ADCs with deruxtecan, exatecan or camptothecan as a payload.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- The University of Alabama · Birmingham, Alabama
- Mount Sinai · New York, New York
- Christ Hospital · Cincinnati, Ohio
- Ohio State University · Columbus, Ohio
- OU Health Stephenson Cancer Center · Oklahoma City, Oklahoma
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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