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
Stage 1
The primary objectives are:
To optimize ABBV-400 monotherapy dose to determine the recommended Phase 3 dose (RP3D)
in subjects with c-Met OE unresectable refractory mCRC.
To evaluate the efficacy of ABBV-400 monotherapy dose as measured by objective response
(OR) in subjects with c-Met OE unresectable refractory mCRC.
To evaluate the safety of ABBV-400 monotherapy in subjects with c-Met OE unresectable
refractory mCRC.
Secondary
The secondary objectives are:
To evaluate the efficacy as measured by progression free survival (PFS), and overall survival (OS) of ABBV-400 monotherapy.
To evaluate clinical outcomes such as duration of response (DOR), disease control rate (DCR) of ABBV-400 monotherapy.
To evaluate the pharmacokinetic (PK) profile of ABBV-400 monotherapy.
Stage 2
The primary objectives are:
To demonstrate the superiority of ABBV-400 over LONSURF (Trifluridine and Tipiracil) plus
bevacizumab in terms of objective response (OR).
To demonstrate the superiority of ABBV-400 over LONSURF (Trifluridine and Tipiracil) plus
bevacizumab in terms of overall survival (OS).
The secondary objectives are:
To evaluate the efficacy as measured by progression free survival (PFS) of ABBV-400
monotherapy.
To evaluate the impact of ABBV-400 on key patient-reported outcomes (PROs) by assessing
symptoms, functional impacts and overall quality of life (QoL) from the patient's perspective.
To evaluate the safety of ABBV-400 monotherapy.
To evaluate clinical outcomes such as duration of response (DOR), disease control rate (DCR) of ABBV-400 monotherapy.
Rectum
BEVACIZUMAB
LONSURF
Chemotherapy single agent systemic
- RWJBarnabas Health
- Cooperman Barnabas, Livingston
- Newark Beth Israel Medical Center
- Rutgers University
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.
Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site ClinicalTrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.
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