Skip to content

A Phase 2, Open-Label, Randomized, Master Protocol Study to Evaluate Safety and Efficacy of Multiple Treatment Combinations with Telisotuzumab Adizutecan in Subjects with Metastatic Colorectal Cancer (AndroMETa-CRC-533)

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-512981-33-00
Acronym
M24-533
Enrollment
104
Registered
2025-06-25
Start date
2025-07-09
Completion date
Unknown
Last updated
2025-11-25

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

Substudy 1 and 2: Objective response as assessed by the investigator: confirmed Complete Response (CR) or Partial Response (PR) as assessed by the investigator per RECIST, version 1.1. A repeat assessment must confirm response at least 28 days from the first documented response.

Detailed description

Substudy 1 and 2: Progression-Free Survival as assessed by the investigator: PFS is defined as the time from the first dose of study treatment to the first occurrence of radiographic progression based on RECIST version 1.1 as determined by the investigator or death from any cause, whichever occurs earlier., Substudy 1 and 2: DOR as assessed by the investigator: The time from the first documented CR or PR to the first occurrence of radiographic progression per RECIST v1.1 as determined by the investigator or death from any cause, whichever occurs first. DOR is defined for subjects with confirmed CR/PR., Substudy 1 and 2: Overall survival: defined as the time from first dose of study treatment to the event of death from any cause., Substudy 1 and 2: Disease Control as assessed by the investigator: best overall response of confirmed CR or confirmed PR, or Stable Disease (SD) based on RECIST, version 1.1 as determined by the investigator.

Interventions

DRUGBEVACIZUMAB
DRUGFOLINIC ACID
DRUGPANITUMUMAB
DRUGFLUOROURACIL
DRUGOXALIPLATIN

Sponsors

AbbVie Deutschland GmbH & Co. KG
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Substudy 1 and 2: Objective response as assessed by the investigator: confirmed Complete Response (CR) or Partial Response (PR) as assessed by the investigator per RECIST, version 1.1. A repeat assessment must confirm response at least 28 days from the first documented response.

Secondary

MeasureTime frame
Substudy 1 and 2: Progression-Free Survival as assessed by the investigator: PFS is defined as the time from the first dose of study treatment to the first occurrence of radiographic progression based on RECIST version 1.1 as determined by the investigator or death from any cause, whichever occurs earlier., Substudy 1 and 2: DOR as assessed by the investigator: The time from the first documented CR or PR to the first occurrence of radiographic progression per RECIST v1.1 as determined by the investigator or death from any cause, whichever occurs first. DOR is defined for subjects with confirmed CR/PR., Substudy 1 and 2: Overall survival: defined as the time from first dose of study treatment to the event of death from any cause., Substudy 1 and 2: Disease Control as assessed by the investigator: best overall response of confirmed CR or confirmed PR, or Stable Disease (SD) based on RECIST, version 1.1 as determined by the investigator.

Countries

Austria, Czechia, France, Greece, Italy, Spain

Outcome results

None listed

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