A Randomized, Open Label, 3-arm Phase 3 Study of Precemtabart Tocentecan with or Without Bevacizumab Compared to Trifluridine/Tipiracil plus Bevacizumab in Participants with Previously Treated Metastatic Colorectal Cancer (PROCEADE-CRC-03)

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-524648-37-00

Enrollment

170

Registered

2026-07-14

Start date

Unknown

Completion date

Unknown

Last updated

2026-07-15

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

Conditions

Metastatic colorectal cancer

Brief summary

Arm 1, 2 and 3: overall survival (OS)

Detailed description

Arm 1 and Arm 2: overall survival (OS), Progression free survival (PFS), Objective response (OR) according to RECIST v1.1 as assessed by Investigator, Duration of response (DoR) according to RECIST v1.1 as assessed by Investigator, Number of Participants with Adverse Events (AEs) and Treatment Related Adverse Events, Observed Concentration at End of Infusion (CEOI), Concentration Observed at the end of a Dosing Interval Immediately Before next Dosing (Ctrough), Number of Participants with Anti-Drug Antibody as measured by ADA assay, Change from Baseline in Global Health Status, Physical, and Role Functioning Subscale Scores of European Organization for research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30)

Interventions

DRUGLonsurf 15 mg/6.14 mg film-coated tablets

DRUGAvastin 25 mg/ml concentrate for solution for infusion.

DRUGM9140

DRUGLonsurf 20 mg/8.19 mg film-coated tablets

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Arm 1, 2 and 3: overall survival (OS)	—

Secondary

Measure	Time frame
Arm 1 and Arm 2: overall survival (OS), Progression free survival (PFS), Objective response (OR) according to RECIST v1.1 as assessed by Investigator, Duration of response (DoR) according to RECIST v1.1 as assessed by Investigator, Number of Participants with Adverse Events (AEs) and Treatment Related Adverse Events, Observed Concentration at End of Infusion (CEOI), Concentration Observed at the end of a Dosing Interval Immediately Before next Dosing (Ctrough), Number of Participants with Anti-Drug Antibody as measured by ADA assay, Change from Baseline in Global Health Status, Physical, and Role Functioning Subscale Scores of European Organization for research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30)	—

Measure

Time frame

—

Outcome results

None listed

Source: EU CTIS · Data processed: Jul 16, 2026