West Cancer Center

COLORECTAL: METASTATIC: 3rd Line: cMET+: M24-064

AndroMETa-CRC-064 Abbvie M24-064: 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

Title

Abbvie M24-064 Colon 3rd line cMET+

Study Title

Site Link

NCT06614192

Malignancy

Colorectal, colon, rectum, rectal

Stage

Stage 4

Disease Setting

Metastatic/Palliative

Line Of Therapy

3rd or later

Investigational Agent

ABBV-400

Drug Class

Anti-cMET ADC

Axel Grothey, MD

Sponsor

Abbvie

Phase

Phase 3

Status

Open to Enrollment

Key Eligibility Criteria

Key Eligibility Criteria Details

Histologically or cytologically confirmed unresectable metastatic adenocarcinoma of the colon or recturm
Has already received the following regimens for advanced colorectal cancer and has demonstrated PD or intolerance to their last regimen
- Must have included a fluoropyrimidine, irinotecan, oxaliplatin, and an anti-VEGF monoclonal antibody, as well as an anti-EGFR antibody if indicated
- Patients who received adjuvant therapy and had recurrence within 12 months can count the therapy as one regimen of therapy for advanced disease
- No prior lonsurf
- Patients with MSI-h/dMMR or BRAF mt should have received appropriate therapy
Measurable disease
ECOG PS 0-1
EF >50%
No untreated CNS disease
No bevacizumab bleeding risks

Objective

Primary
- ORR
- OS
Secondary
- PFS
- DoR
- DCR
- QoL
- Safety

Assessment Frequency

Assessment Frequency 2

Assessment Frequency Link

Path

Adenocarcinoma

Dosing Frequency

Control Agents

Study Protocol

Randomized

Yes