TUB-040

DRUG4 trials

Sponsors

Tubulis GmbH

Conditions

High-grade epithelial serous or endometrioid epithelial ovarian cancerNSCLCNon Small Cell Lung CancerNon-small Cell Lung CancerOvarian CancerPlatinum-resistant high-grade ovarian cancer (PROC) or relapsed/refractory adenocarcinoma non-small cell lung cancer (NSCLC)

Phase 1

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

RecruitingNCT06303505

Tubulis GmbHNon-small Cell Lung Cancer, Ovarian Cancer

Start: 2024-06-12End: 2027-12-01Target: 250Updated: 2026-09-14

A multicenter, first-in-human, dose escalation and optimization phase I/IIa study to investigate safety, tolerability, pharmacokinetics, and efficacy of the NaPi2b antibody-drug conjugate TUB-040 in patients with platinum-resistant high-grade ovarian cancer (PROC) or relapsed/refractory adenocarcinoma non-small cell lung cancer (NSCLC) (NAPISTAR 1-01).

RecruitingCTIS2024-511074-80-01

Tubulis GmbHPlatinum-resistant high-grade ovarian cancer (PROC) or relapsed/refractory adenocarcinoma non-small cell lung cancer (NSCLC)

Start: 2024-09-06Target: 99Updated: 2025-12-08

A multicenter, Phase Ib/II study to evaluate the safety, tolerability, pharmacokinetics and preliminary clinical activity of TUB-040, in combination with standard ovarian cancer drugs in patients with high-grade epithelial serous or endometrioid epithelial ovarian cancer (OC) (NAPISTAR 1-02)

Not yet recruitingCTIS2025-524691-33-00

Tubulis GmbHHigh-grade epithelial serous or endometrioid epithelial ovarian cancer

Target: 42Updated: 2026-02-12

Phase 2

Study of TUB-040 in Participants With Unresectable or Metastatic Nonsquamous Non-small Cell Lung Cancer

Not yet recruitingNCT07806773

Tubulis GmbHNon Small Cell Lung Cancer, NSCLC

Start: 2026-11-01End: 2029-05-01Target: 80Updated: 2026-09-16

Related Papers

NAPISTAR 1-01: Results of phase 1 dose escalation of monotherapy with TUB-040, a novel NaPi2b-targeting exatecan ADC, in patients (pts) with platinum-resistant ovarian cancer (PROC).

Journal of Clinical Oncology2026-05-27

NAPISTAR 1-01: An international phase I/II trial of the novel ADC TUB-040 in platinum-resistant ovarian cancer (PROC) and relapsed/refractory adenocarcinoma non-small cell lung cancer (NSCLC).

Journal of Clinical Oncology2025-05-281 citations