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Trial 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
NCT ID:
NCT06614192
Condition:
Metastatic Colorectal Cancer
Conditions: Official terms:
Colorectal Neoplasms
Trifluridine
Bevacizumab
Conditions: Keywords:
Metastatic Colorectal Cancer
ABBV-400
Trifluridine
Tipiracil
LONSURF
Bevacizumab
AndroMETa-CRC-064
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
ABBV-400
Description:
Intravenous (IV) Infusion
Arm group label:
Stage 1: ABBV-400 Dose A
Arm group label:
Stage 1: ABBV-400 Dose B
Arm group label:
Stage 2: ABBV-400 Optimal Dose
Intervention type:
Drug
Intervention name:
Trifluridine/Tipiracil
Description:
Oral Tablet
Arm group label:
Stage 2: Standard of Care (SOC)
Other name:
LONSURF
Intervention type:
Drug
Intervention name:
Bevacizumab
Description:
IV Infusion
Arm group label:
Stage 2: Standard of Care (SOC)
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 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 (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.
Criteria for eligibility:
Criteria:
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.
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
November 24, 2024
Completion date:
April 6, 2029
Lead sponsor:
Agency:
AbbVie
Agency class:
Industry
Source:
AbbVie
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06614192
https://www.abbvieclinicaltrials.com/study/?id=M24-064
