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)

Status

Not yet recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-524691-33-00

Enrollment

Registered

2026-02-12

Start date

Unknown

Completion date

Unknown

Last updated

2026-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

High-grade epithelial serous or endometrioid epithelial ovarian cancer

Brief summary

• Occurrence and severity of treatment-emergent adverse events (TEAEs), • Occurrence of DLTs (Dose limiting toxicities) at different dose levels (during first treatment cycle)

Detailed description

•PK parameters of TUB-040 ADC, total mAb and free exatecan, including but not limited to maximum concentration Cmax, time to Cmax (Tmax), area under the curve (AUC) and as far as collected data allow an estimation of half-life (t1/2), • Incidence and titers of anti-drug antibodies (ADA) against TUB-040, • Objective response rate (ORR) by RECIST v1.1 assessed by Investigator (INV), • Time to first response (TTR) by RECIST v1.1 assessed by INV, • Duration of response (DoR) by RECIST v1.1 assessed by INV, • Progression-free survival (PFS) by RECIST v1.1 assessed by INV, • Number of patients with Gynecologic Cancer Intergroup (GCIG) CA-125 criteria clinical responses, • Incidence of serious adverse events (SAEs), • Incidence of ≥Grade 3 laboratory abnormalities

Interventions

DRUGTUB-040

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
• Occurrence and severity of treatment-emergent adverse events (TEAEs), • Occurrence of DLTs (Dose limiting toxicities) at different dose levels (during first treatment cycle)	—

Secondary

Measure	Time frame
•PK parameters of TUB-040 ADC, total mAb and free exatecan, including but not limited to maximum concentration Cmax, time to Cmax (Tmax), area under the curve (AUC) and as far as collected data allow an estimation of half-life (t1/2), • Incidence and titers of anti-drug antibodies (ADA) against TUB-040, • Objective response rate (ORR) by RECIST v1.1 assessed by Investigator (INV), • Time to first response (TTR) by RECIST v1.1 assessed by INV, • Duration of response (DoR) by RECIST v1.1 assessed by INV, • Progression-free survival (PFS) by RECIST v1.1 assessed by INV, • Number of patients with Gynecologic Cancer Intergroup (GCIG) CA-125 criteria clinical responses, • Incidence of serious adverse events (SAEs), • Incidence of ≥Grade 3 laboratory abnormalities	—

Measure

Time frame

—

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 13, 2026