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

AbbVie

Status and phase: Enrolling; Phase 3

Conditions: Metastatic Colorectal Cancer

Treatments: Drug: ABBV-400; Drug: Trifluridine/Tipiracil; Drug: Bevacizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT06614192

2024-512804-20-00 (Other Identifier)

M24-064

Details and patient eligibility

About

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.

Enrollment: 460 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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460 participants in 4 patient groups

Stage 1: ABBV-400 Dose A

Experimental group

Description:

Participants will receive ABBV-400 dose A, as part of the approximately 4 year study duration.

Treatment:

Drug: ABBV-400

Stage 1: ABBV-400 Dose B

Experimental group

Description:

Participants will receive ABBV-400 dose B, as part of the approximately 4 year study duration.

Treatment:

Drug: ABBV-400

Stage 2: ABBV-400 Optimal Dose

Experimental group

Description:

Participants will receive the optimal dose of ABBV-400, as part of the approximately 4 year study duration.

Treatment:

Drug: ABBV-400

Stage 2: Standard of Care (SOC)

Experimental group

Description:

Participants will receive the SOC, as part of the approximately 4 year study duration.

Treatment:

Drug: Bevacizumab

Drug: Trifluridine/Tipiracil