Study to Assess Adverse Events and Change in Disease Activity in Previously Treated Adult Participants Receiving Intravenous (IV) ABBV-400 With Unresectable Metastatic Colorectal Cancer in Combination With IV Fluorouracil, Folinic Acid, and Bevacizumab

Phase 2

Recruiting

• Conditions: Colorectal Cancer
• Interventions: Drug: ABBV-400; Drug: Bevacizumab; Drug: Folinic Acid; Drug: Fluorouracil; Drug: Irinotecan

• Registration Number: 2023-505110-14-00
• Lead Sponsor: AbbVie Deutschland GmbH & Co. KG

Brief Summary

- To optimize ABBV-400 dose in combination with 5-FU, folinic acid, and bevacizumab to determine the RP3D regimen for the combination.

- To evaluate the efficacy as measured by OR and PFS of ABBV-400 in combination with 5-FU, folinic acid, and bevacizumab

- To evaluate the safety and tolerability of ABBV-400 in combination with 5-FU, folinic acid, and bevacizumab

Detailed Description

Not available

Study Timeline

• Study First Posted: 2024-08-02
• Last Update Posted: 2025-04-03

Recruitment & Eligibility

• Status: Ongoing, recruiting
• Sex: Not specified
• Target Recruitment: 61

Inclusion Criteria

Diagnosis of histologically or cytologically confirmed unresectable metastatic colorectal cancer (mCRC).

Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

Exclusion Criteria

Harbor the BRAF V600E mutation.

dMMR+/MSI-H.

Progressed on only one first-line (1L) systemic treatment of combination chemotherapy in the metastatic setting with or without targeted therapy.

Received anticancer therapy including chemotherapy, radiation therapy, immunotherapy, biologic, or any investigational therapy within 28 days or 5 half-lives of the drug (whichever is shorter) prior to the first dose of ABBV-400.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Stage 1: ABBV-400+FFB A	ABBV-400	Participants will receive escalating ABBV-400 in combination with Fluorouracil, Folinic Acid, and Bevacizumab (FFB) on dose schedule A as part of the safety lead in, during the 3 year study duration.
Stage 1: ABBV-400+FFB A	Bevacizumab	Participants will receive escalating ABBV-400 in combination with Fluorouracil, Folinic Acid, and Bevacizumab (FFB) on dose schedule A as part of the safety lead in, during the 3 year study duration.
Stage 1: ABBV-400+FFB A	Folinic Acid	Participants will receive escalating ABBV-400 in combination with Fluorouracil, Folinic Acid, and Bevacizumab (FFB) on dose schedule A as part of the safety lead in, during the 3 year study duration.
Stage 1: ABBV-400+FFB A	Fluorouracil	Participants will receive escalating ABBV-400 in combination with Fluorouracil, Folinic Acid, and Bevacizumab (FFB) on dose schedule A as part of the safety lead in, during the 3 year study duration.
Stage 1: ABBV-400+FFB B	ABBV-400	Participants will receive escalating ABBV-400 in combination with FFB on dose schedule B as part of the safety lead in, during the 3 year study duration.
Stage 1: ABBV-400+FFB B	Bevacizumab	Participants will receive escalating ABBV-400 in combination with FFB on dose schedule B as part of the safety lead in, during the 3 year study duration.
Stage 1: ABBV-400+FFB B	Folinic Acid	Participants will receive escalating ABBV-400 in combination with FFB on dose schedule B as part of the safety lead in, during the 3 year study duration.
Stage 1: ABBV-400+FFB B	Fluorouracil	Participants will receive escalating ABBV-400 in combination with FFB on dose schedule B as part of the safety lead in, during the 3 year study duration.
Stage 2: ABBV-400+FFB A Low	ABBV-400	Participants will receive ABBV-400 in combination with FFB at the low dose determined in the safety lead in on dose schedule A as part of the dose optimization, during the 3 year study duration.
Stage 2: ABBV-400+FFB A Low	Bevacizumab	Participants will receive ABBV-400 in combination with FFB at the low dose determined in the safety lead in on dose schedule A as part of the dose optimization, during the 3 year study duration.
Stage 2: ABBV-400+FFB A Low	Folinic Acid	Participants will receive ABBV-400 in combination with FFB at the low dose determined in the safety lead in on dose schedule A as part of the dose optimization, during the 3 year study duration.
Stage 2: ABBV-400+FFB A Low	Fluorouracil	Participants will receive ABBV-400 in combination with FFB at the low dose determined in the safety lead in on dose schedule A as part of the dose optimization, during the 3 year study duration.
Stage 2: ABBV-400+FFB A High	ABBV-400	Participants will receive ABBV-400 in combination with FFB at the high dose determined in the safety lead in on dose schedule A as part of the dose optimization, during the 3 year study duration.
Stage 2: ABBV-400+FFB A High	Bevacizumab	Participants will receive ABBV-400 in combination with FFB at the high dose determined in the safety lead in on dose schedule A as part of the dose optimization, during the 3 year study duration.
Stage 2: ABBV-400+FFB A High	Folinic Acid	Participants will receive ABBV-400 in combination with FFB at the high dose determined in the safety lead in on dose schedule A as part of the dose optimization, during the 3 year study duration.
Stage 2: ABBV-400+FFB A High	Fluorouracil	Participants will receive ABBV-400 in combination with FFB at the high dose determined in the safety lead in on dose schedule A as part of the dose optimization, during the 3 year study duration.
Stage 2: FFB+Irinotecan (Standard of Care [SOC])	Bevacizumab	Participants will receive SOC during the 3 year study duration.
Stage 2: FFB+Irinotecan (Standard of Care [SOC])	Folinic Acid	Participants will receive SOC during the 3 year study duration.
Stage 2: FFB+Irinotecan (Standard of Care [SOC])	Fluorouracil	Participants will receive SOC during the 3 year study duration.
Stage 2: FFB+Irinotecan (Standard of Care [SOC])	Irinotecan	Participants will receive SOC during the 3 year study duration.
Stage 3: ABBV-400+FFB B Low	ABBV-400	Participants will receive ABBV-400 in combination with FFB at the low dose determined in the safety lead in on dose schedule B as part of the dose optimization/expansion, during the 3 year study duration.
Stage 3: ABBV-400+FFB B Low	Bevacizumab	Participants will receive ABBV-400 in combination with FFB at the low dose determined in the safety lead in on dose schedule B as part of the dose optimization/expansion, during the 3 year study duration.
Stage 3: ABBV-400+FFB B Low	Folinic Acid	Participants will receive ABBV-400 in combination with FFB at the low dose determined in the safety lead in on dose schedule B as part of the dose optimization/expansion, during the 3 year study duration.
Stage 3: ABBV-400+FFB B Low	Fluorouracil	Participants will receive ABBV-400 in combination with FFB at the low dose determined in the safety lead in on dose schedule B as part of the dose optimization/expansion, during the 3 year study duration.
Stage 3: ABBV-400+Bevacizumab C High	ABBV-400	Participants will receive ABBV-400 in combination with Bevacizumab at the high dose determined in the safety lead in on dose schedule C as part of the dose optimization/expansion, during the 3 year study duration.
Stage 3: ABBV-400+Bevacizumab C High	Bevacizumab	Participants will receive ABBV-400 in combination with Bevacizumab at the high dose determined in the safety lead in on dose schedule C as part of the dose optimization/expansion, during the 3 year study duration.

Primary Outcome Measures

Name	Time	Method
Objective Response as assessed by the investigator		Objective Response as assessed by the investigator
Progression Free Survival (PFS) as assessed by the investigator		Progression Free Survival (PFS) as assessed by the investigator

Secondary Outcome Measures

Name	Time	Method
Duration of Response (DOR) as assessed by the investigator		Duration of Response (DOR) as assessed by the investigator
Overall Survival (OS)		Overall Survival (OS)
Best Overall Response (BOR) as assessed by the investigator		Best Overall Response (BOR) as assessed by the investigator

Trial Locations

Locations (19)

Technische Universitaet Dresden; 🇩🇪 Dresden, Germany

Universitaetsklinikum Ulm AöR; 🇩🇪 Ulm, Germany

Charite Universitaetsmedizin Berlin KöR; 🇩🇪 Berlin, Germany

University Medical Center Hamburg-Eppendorf; 🇩🇪 Hamburg, Germany

Universitat Heidelberg; 🇩🇪 Mannheim, Germany

Universitaetsklinikum Tuebingen AöR; 🇩🇪 Tuebingen, Germany

Hospital Universitari Vall D Hebron; 🇪🇸 Barcelona, Spain

Hospital Unviersitario Miguel Servet; 🇪🇸 Zaragoza, Spain

Hospital Universitario 12 De Octubre; 🇪🇸 Madrid, Spain

Hospital General Universitario Gregorio Maranon; 🇪🇸 Madrid, Spain

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Technische Universitaet Dresden

🇩🇪Dresden, Germany

Gunnar Folprecht

Site contact

00493514587666

oncostudy@ukdd.de