Drugs / TUB-040
last change Apr 2026 re-read 3 minutes ago

TUB-040

Developed for
non-small cell lung carcinoma · ovarian cancer
Investigated by
Tubulis GmbH

Trials 1

2025202620272028
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 1/2 NCT06303505 Jun 2024 → Dec 2027 expected non-small cell lung carcinoma, ovarian cancer Tubulis GmbH Recruiting No outcome recorded

News releases announcing trial results or a regulatory action · 3

DateIssuerRelease
2025-10-19 Tubulis GmbH Results Tubulis Presents First Clinical Data from Phase I/IIa Trial for TUB-040 in Platinum-Resistant Ovarian Cancer (PROC) at ESMO 2025 tubulis.com ↗
Tubulis today announced positive early clinical data from its NAPISTAR1-01 Phase I/IIa study ( NCT06303505 ) in a late-breaking oral presentation at the European Society for Medical Oncology (ESMO) Congress 2025 in Berlin, Germany.
2024-06-27 Tubulis GmbH Regulatory Tubulis Receives FDA Fast Track Designation for Antibody-Drug Conjugate Candidate TUB-040 in Platinum-resistant Ovarian Cancer tubulis.com ↗
Tubulis announced today that the U.S. Food and Drug Administration (“FDA”) has granted Fast Track designation to its lead antibody-drug conjugate (ADC) TUB-040 for the treatment of patients with platinum-resistant ovarian cancer.
2024-04-08 Tubulis GmbH Results Tubulis Presents Preclinical Data for Solid Tumor Targeting ADC Candidates TUB-030 and TUB-040 Demonstrating Superior Efficacy Profile and a Wide Therapeutic Window at the AACR Annual Meeting 2024 tubulis.com ↗
The poster presentations contained preclinical data, highlighting the ability of the two next-generation Tubutecan ADCs to create effective and durable responses even in low target-expressing tumor mouse models.

Evidence & citations 2 cited values

Every value below carries the sentence it was read from. 1 source stands behind the page.

FieldValueCited text
Known as TUB-040 ClinicalTrials.gov intervention name — accepted as the source's own label NCT06303505 ↗
Route Intravenous “TUB-040 will be administered as an intravenous (IV) solution on day 1 of each treatment cycle” NCT06303505 ↗