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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06820463




Registration number
NCT06820463
Ethics application status
Date submitted
6/02/2025
Date registered
11/02/2025
Date last updated
4/06/2025

Titles & IDs
Public title
A Study to Evaluate the Adverse Events, and Efficacy of Intravenous (IV) of Telisotuzumab Adizutecan in Combination With IV Oxaliplatin, Fluorouracil, Folinic Acid/Leucovorin, Bevacizumab, Panitumumab in Adult Participants With Metastatic Colorectal Cancer
Scientific title
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
Secondary ID [1] 0 0
EU CT
Secondary ID [2] 0 0
M24-533
Universal Trial Number (UTN)
Trial acronym
AndroMETa-CRC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metastatic Colorectal Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Telisotuzumab Adizutecan
Treatment: Drugs - Fluorouracil
Treatment: Drugs - Oxaliplatin
Treatment: Drugs - Leucovorin
Treatment: Drugs - Bevacizumab
Treatment: Drugs - Panitumumab

Experimental: Substudy 1: Dose Escalation Telisotuzumab Adizutecan - Participants will receive various doses of telisotuzumab adizutecan in combination with a fixed dose of fluorouracil, leucovorin, and oxaliplatin (FOLFOX) and bevacizumab as part of the approximately 6 year study duration.

Experimental: Substudy 1: Dose Expansion Telisotuzumab Adizutecan High Dose - Participants will receive the high dose of telisotuzumab adizutecan determined in the dose expansion arm in combination with a fixed dose of FOLFOX and bevacizumab as part of the approximately 6 year study duration.

Experimental: Substudy 1: Dose Expansion Telisotuzumab Adizutecan Low Dose - Participants will receive the low dose of telisotuzumab adizutecandetermined in the dose expansion arm in combination with a fixed dose of FOLFOX and bevacizumab as part of the approximately 6 year study duration.

Experimental: Substudy 1: Dose Expansion Compatator - Participants will receive a fixed dose of FOLFOX and bevacizumab as part of the approximately 6 year study duration.

Experimental: Substudy 2: Dose Escalation Telisotuzumab Adizutecan - Participants will receive various doses of telisotuzumab adizutecan in combination with a fixed dose of fluorouracil (5-FU) and leucovorin (LV) and panitumumab as part of the approximately 6 year study duration.

Experimental: Substudy 2: Dose Expansion Telisotuzumab Adizutecan High Dose - Participants will receive the high dose of telisotuzumab adizutecan determined in the dose expansion arm in combination with a fixed dose of 5-FU/LV and panitumumab as part of the approximately 6 year study duration.

Experimental: Substudy 2: Dose Expansion Telisotuzumab Adizutecan Low Dose - Participants will receive the low dose of telisotuzumab adizutecan determined in the dose expansion arm in combination with a fixed dose of 5-FU/LV and panitumumab as part of the approximately 6 year study duration.

Experimental: Substudy 2: Dose Expansion Compatator - Participants will receive a fixed dose of FOLFOX and panitumumab as part of the approximately 6 year study duration.


Treatment: Drugs: Telisotuzumab Adizutecan
Intravenous (IV) Infusion

Treatment: Drugs: Fluorouracil
IV Infusion; IV Injection

Treatment: Drugs: Oxaliplatin
IV Infusion

Treatment: Drugs: Leucovorin
IV Infusion; IV Injection

Treatment: Drugs: Bevacizumab
IV Infusion

Treatment: Drugs: Panitumumab
IV Infusion
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Objective Response (OR) as Assessed by the Investigator confirmed complete response (CR) or partial response (PR) as assessed by the investigator per response evaluation criteria in solid tumors (RECIST), version 1.1.
Timepoint [1] 0 0
Up to 24 Weeks
Primary outcome [2] 0 0
Number of Participants with Adverse Events (AE)s
Timepoint [2] 0 0
Up to Approximately 6 Years
Secondary outcome [1] 0 0
Progression-Free Survival (PFS) as Assessed by the Investigator
Timepoint [1] 0 0
Up to 22 Months
Secondary outcome [2] 0 0
Duration of Response (DOR) as Assessed by the investigator
Timepoint [2] 0 0
Up to 14 Months
Secondary outcome [3] 0 0
Overall Survival (OS)
Timepoint [3] 0 0
Up to Approximately 6 Years
Secondary outcome [4] 0 0
Disease Control (DC) as Assessed by the Investigator
Timepoint [4] 0 0
Up to Approximately 6 Years

Eligibility
Key inclusion criteria
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Laboratory values meeting the criteria within the protocol.
* Has measurable disease per response evaluation criteria in solid tumors (RECIST) v1.1.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Prior systemic regimen containing c-Met targeting agent(s) (e.g., antibody, antibody drug conjugate, bispecific) and/or any topoisomerase inhibitor(s) (e.g., irinotecan).
* History of other malignancies within 5 years prior to screening, except for malignancies with a negligible risk of metastasis or death.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
24/04/2025
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/04/2028
Actual
Sample size
Target
390
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Austin Health /ID# 270692 - Heidelberg
Recruitment postcode(s) [1] 0 0
3084 - Heidelberg
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Connecticut
Country [2] 0 0
United States of America
State/province [2] 0 0
Illinois
Country [3] 0 0
United States of America
State/province [3] 0 0
Nebraska
Country [4] 0 0
Israel
State/province [4] 0 0
H_efa
Country [5] 0 0
Israel
State/province [5] 0 0
Tel-Aviv
Country [6] 0 0
Israel
State/province [6] 0 0
Jerusalem
Country [7] 0 0
Israel
State/province [7] 0 0
Petah Tikva
Country [8] 0 0
Japan
State/province [8] 0 0
Tokyo
Country [9] 0 0
Puerto Rico
State/province [9] 0 0
Rio Piedras
Country [10] 0 0
Taiwan
State/province [10] 0 0
Kaohsiung
Country [11] 0 0
Taiwan
State/province [11] 0 0
Tainan
Country [12] 0 0
Taiwan
State/province [12] 0 0
Taipei City

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AbbVie
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
ABBVIE INC.
Address 0 0
AbbVie
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
ABBVIE CALL CENTER
Address 0 0
Country 0 0
Phone 0 0
844-663-3742
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT06820463