A PHASE 1/2 STUDY OF ONCOBAX®-AK ADMINISTERED IN COMBINATION WITH IMMUNOTHERAPY TO PATIENTS WITH ADVANCED SOLID TUMORS

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-516711-24-00

Acronym

EV-2101

Enrollment

128

Registered

2024-10-04

Start date

2022-10-18

Completion date

Unknown

Last updated

2025-07-10

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

Conditions

Non-Small Cell Lung Cancer (NSCLC), Renal Cell Carcinoma (RCC)

Brief summary

Phase 1: - AEs, TEAEs, related TEAEs, SAEs, DLTs per NCI CTCAE version 5.0. - Dose reductions and interruptions. Phase 2: - ORR per iRECIST

Detailed description

Phase 2: - PFS9, OS12, DOR. - AEs, TEAEs, related TEAEs, SAEs, DLTs, per NCI-CTCAE version 5.0. - Dose reductions and interruptions

Interventions

DRUGOncobax®-AK

DRUGLIBTAYO 350 mg concentrate for solution for infusion.

DRUGOPDIVO 10 mg/mL concentrate for solution for infusion.

DRUGYERVOY 5 mg/ml concentrate for solution for infusion

DRUGTecentriq 1 200 mg concentrate for solution for infusion

DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Phase 1: - AEs, TEAEs, related TEAEs, SAEs, DLTs per NCI CTCAE version 5.0. - Dose reductions and interruptions. Phase 2: - ORR per iRECIST	—

Secondary

Measure	Time frame
Phase 2: - PFS9, OS12, DOR. - AEs, TEAEs, related TEAEs, SAEs, DLTs, per NCI-CTCAE version 5.0. - Dose reductions and interruptions	—

Countries

Belgium, France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026