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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06614192




Registration number
NCT06614192
Ethics application status
Date submitted
25/09/2024
Date registered
26/09/2024
Date last updated
11/02/2025

Titles & IDs
Public title
A Randomized Trial Assessing Adverse Events and Disease Activity When Comparing Intravenously (IV) Infused ABBV-400 to Trifluridine and Tipiracil (LONSURF) Oral Tablets Plus IV Infused Bevacizumab in Adult Participants With c-Met Over-Expressed Refractory Metastatic Colorectal Cancer
Scientific title
AndroMETa-CRC-064: An Open Label, Randomized, Controlled, Global Phase 3 Study Comparing ABBV-400 Monotherapy to LONSURF (Trifluridine and Tipiracil) Plus Bevacizumab in Subjects With c-Met Over-Expressed Refractory Metastatic Colorectal Cancer
Secondary ID [1] 0 0
2024-512804-20-00
Secondary ID [2] 0 0
M24-064
Universal Trial Number (UTN)
Trial acronym
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 - ABBV-400
Treatment: Drugs - Trifluridine/Tipiracil
Treatment: Drugs - Bevacizumab

Experimental: Stage 1: ABBV-400 Dose A - Participants will receive ABBV-400 dose A, as part of the approximately 4 year study duration.

Experimental: Stage 1: ABBV-400 Dose B - Participants will receive ABBV-400 dose B, as part of the approximately 4 year study duration.

Experimental: Stage 2: ABBV-400 Optimal Dose - Participants will receive the optimal dose of ABBV-400, as part of the approximately 4 year study duration.

Experimental: Stage 2: Standard of Care (SOC) - Participants will receive the SOC, as part of the approximately 4 year study duration.


Treatment: Drugs: ABBV-400
Intravenous (IV) Infusion

Treatment: Drugs: Trifluridine/Tipiracil
Oral Tablet

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

Outcomes
Primary outcome [1] 0 0
Stage 1: Percentage of Participants with Adverse Events (AE)s
Timepoint [1] 0 0
Up to a Maximum of 4 Years
Primary outcome [2] 0 0
Stage 1: Percentage of Participants with Clinically Significant Vital Sign Measurements as Assessed by the Investigator
Timepoint [2] 0 0
Up to a Maximum of 4 Years
Primary outcome [3] 0 0
Stage 1: Percentage of Participants with Clinically Significant Electrocardiograms (ECGs) Findings as Assessed by the Investigator
Timepoint [3] 0 0
Up to a Maximum of 4 Years
Primary outcome [4] 0 0
Stage 1: Percentage of Participants with Clinically Significant Laboratory Values (Chemistry, Hematology, Coagulation, and Urinalysis) as Assessed by the Investigator
Timepoint [4] 0 0
Up to a Maximum of 4 Years
Primary outcome [5] 0 0
Stage 1 and Stage 2: Objective Response (OR) as Assessed by Blinded Independent Central Review (BICR)
Timepoint [5] 0 0
Up to a Maximum of 4 Years
Primary outcome [6] 0 0
Stage 2: Overall Survival (OS)
Timepoint [6] 0 0
Up to a Maximum of 4 Years
Secondary outcome [1] 0 0
Stage 1 and Stage 2: Progression Free Survival (PFS) as Assessed by BICR
Timepoint [1] 0 0
Up to a Maximum of 4 Years
Secondary outcome [2] 0 0
Stage 1: OS
Timepoint [2] 0 0
Up to a Maximum of 4 Years
Secondary outcome [3] 0 0
Stage 1 and Stage 2: Duration of Response (DOR) as Assessed by BICR
Timepoint [3] 0 0
Up to a Maximum of 4 Years
Secondary outcome [4] 0 0
Stage 1 and Stage 2: Disease Control (DC) as Assessed by BICR
Timepoint [4] 0 0
Up to a Maximum of 4 Years
Secondary outcome [5] 0 0
Stage 1 and Stage 2: OR as Assessed by Investigator
Timepoint [5] 0 0
Up to a Maximum of 4 Years
Secondary outcome [6] 0 0
Stage 1 and Stage 2: PFS as Assessed by Investigator
Timepoint [6] 0 0
Up to a Maximum of 4 Years
Secondary outcome [7] 0 0
Stage 1 and Stage 2: DOR as Assessed by Investigator
Timepoint [7] 0 0
Up to a Maximum of 4 Years
Secondary outcome [8] 0 0
Stage 1: Maximum Observed Serum (or Plasma, for Payload) Concentration (Cmax) for ABBV-400
Timepoint [8] 0 0
Up to a Maximum of 4 Years
Secondary outcome [9] 0 0
Stage 1: Time to Cmax (Tmax) for ABBV-400
Timepoint [9] 0 0
Up to a Maximum of 4 Years
Secondary outcome [10] 0 0
Stage 1: Terminal Elimination Half-Life (t1/2) for ABBV-400
Timepoint [10] 0 0
Up to a Maximum of 4 Years
Secondary outcome [11] 0 0
Stage 1: Area Under the Serum (or Plasma, for Payload) Concentration Versus Time Curve (AUC) for ABBV-400
Timepoint [11] 0 0
Up to a Maximum of 4 Years
Secondary outcome [12] 0 0
Stage 1: Antibody Drug Conjugate (ADC) for ABBV-400
Timepoint [12] 0 0
Up to a Maximum of 4 Years
Secondary outcome [13] 0 0
Stage 1: Unconjugated Topoisomerase 1 (Top1) Inhibitor Payload for ABBV-400
Timepoint [13] 0 0
Up to a Maximum of 4 Years
Secondary outcome [14] 0 0
Stage 1: Incidence of Anti-Drug Antibodies (ADAs) for ABBV-400
Timepoint [14] 0 0
Up to a Maximum of 4 Years
Secondary outcome [15] 0 0
Stage 1: Neutralizing Anti-Drug Antibodies (nADAs) for ABBV-400
Timepoint [15] 0 0
Up to a Maximum of 4 Years
Secondary outcome [16] 0 0
Stage 2: Change from Baseline at C5D1 (ABBV-400 Arm) in Physical Functioning as Measured by the Physical Functioning Domain of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Timepoint [16] 0 0
Up to a Maximum of 4 Years
Secondary outcome [17] 0 0
Stage 2: Change from Baseline at C7D1 (Standard of Care [SOC] Arm) in Physical Functioning as Measured by the Physical Functioning Domain of the EORTC QLQ-C30
Timepoint [17] 0 0
Up to a Maximum of 4 Years
Secondary outcome [18] 0 0
Stage 2: Change from Baseline at C5D1 (ABBV-400 Arm) in in Diarrhea as Measured by the Physical Functioning Domain of the EORTC QLQ-C30
Timepoint [18] 0 0
Up to a Maximum of 4 Years
Secondary outcome [19] 0 0
Stage 2: Change from Baseline at C7D1 (SOC Arm) in Diarrhea as Measured by the Physical Functioning Domain of the EORTC QLQ-C30
Timepoint [19] 0 0
Up to a Maximum of 4 Years
Secondary outcome [20] 0 0
Stage 2: Change from Baseline at C5D1 (ABBV-400 Arm) in in Global Health Status (GHS)/QoL as Measured by the Physical Functioning Domain of the EORTC QLQ-C30
Timepoint [20] 0 0
Up to a Maximum of 4 Years
Secondary outcome [21] 0 0
Stage 2: Change from Baseline at C7D1 (SOC Arm) in GHS/QoL as Measured by the Physical Functioning Domain of the EORTC QLQ-C30
Timepoint [21] 0 0
Up to a Maximum of 4 Years

Eligibility
Key inclusion criteria
* Life expectancy >= 12 weeks per investigator assessment.
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 during the screening period prior to the first dose of the study drug.
* Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1.
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 antibody or Antibody Drug Conjugate (ADC).
* History of allergic reactions or hypersensitivity to bevacizumab or any of its excipients, or to compounds similar to trifluridine/tipiracil.
* Active infection as noted in the protocol.

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
Other
Other design features
Phase
Phase 3
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
8/11/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/04/2029
Actual
Sample size
Target
460
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Mater Hospital Brisbane /ID# 268360 - South Brisbane
Recruitment postcode(s) [1] 0 0
4101 - South Brisbane
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Connecticut
Country [4] 0 0
United States of America
State/province [4] 0 0
Idaho
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
Mississippi
Country [7] 0 0
United States of America
State/province [7] 0 0
Montana
Country [8] 0 0
United States of America
State/province [8] 0 0
New Jersey
Country [9] 0 0
United States of America
State/province [9] 0 0
Tennessee
Country [10] 0 0
United States of America
State/province [10] 0 0
Texas
Country [11] 0 0
United States of America
State/province [11] 0 0
Virginia
Country [12] 0 0
Israel
State/province [12] 0 0
Tel-Aviv
Country [13] 0 0
Israel
State/province [13] 0 0
Haifa
Country [14] 0 0
Israel
State/province [14] 0 0
Jerusalem
Country [15] 0 0
Israel
State/province [15] 0 0
Petah Tikva
Country [16] 0 0
Israel
State/province [16] 0 0
Tel Aviv
Country [17] 0 0
Japan
State/province [17] 0 0
Tokyo
Country [18] 0 0
Korea, Republic of
State/province [18] 0 0
Seoul Teugbyeolsi
Country [19] 0 0
Puerto Rico
State/province [19] 0 0
Rio Piedras
Country [20] 0 0
Taiwan
State/province [20] 0 0
Kaohsiung
Country [21] 0 0
Taiwan
State/province [21] 0 0
Taichung
Country [22] 0 0
Taiwan
State/province [22] 0 0
Taipei City

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

Ethics approval
Ethics application status

Summary
Brief summary
Colorectal cancer (CRC) is the third most common type of cancer diagnosed worldwide and in China. The purpose of this study is to assess adverse events disease activity when comparing intravenously (IV) infused ABBV-400 to trifluridine and tipiracil (LONSURF) oral tablets plus IV infused bevacizumab in adult participants with c-Met over-expressed refractory metastatic colorectal cancer (mCRC).

ABBV-400 is an investigational drug being developed for the treatment of CRC. Participants are put into treatment arms as part of 2 stages. Each treatment arm in stage 1 receives a different dose of ABBV-400. Each treatment arm in stage 2 receives the optimal dose of ABBV-400 or LONSURF plus bevacizumab. Up to approximately 460 adult participants with c-Met over-expressed (OE) refractory mCRC, will be enrolled in the study in approximately 160 sites in 15-20 countries.

In stage 1, participants will receive intravenously (IV) infused ABBV-400 dose A or B. In stage 2, participants will receive the optimal dose of IV infused ABBV-400 or the standard of care (SOC), LONSURF oral tablets plus IV infused bevacizumab. The total study duration will be approximately 4 years.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.
Trial website
https://clinicaltrials.gov/study/NCT06614192
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06614192