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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

AbbVie Deutschland GmbH & Co. KG

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

2 Dec 2024 → ongoing

Decision date (initial)

2024-08-08

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

AbbVie Inc.

External identifiers

EU CT number

2023-505110-14-00

ClinicalTrials.gov

NCT06107413

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacokinetic, Efficacy, Safety

- 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 objective response (OR) and progression-free survival (PFS) of ABBV-400 in combination with 5-FU, folinic acid, and bevacizumab
- To evaluate the efficacy as measured by OR and PFS of ABBV-400 in combination with bevacizumab
- To evaluate the safety and tolerability of ABBV-400 in combination with 5-FU, folinic acid, and bevacizumab
- To evaluate the safety and tolerability of ABBV-400 in combination with bevacizumab

Secondary objectives 3

1. To evaluate clinical outcomes such as duration of response (DOR), overall survival (OS), and disease control, of ABBV-400 in combination with 5-FU, folinic acid, and bevacizumab.
2. To evaluate clinical outcomes such as DOR, OS, and disease control, of ABBV-400 in combination with bevacizumab
3. To evaluate the pharmacokinetics (PK) of ABBV-400 in combination with 5-FU, folinic acid, and bevacizumab

Conditions and MedDRA coding

Colorectal Cancer

Regulatory references

Scientific advice from competent authorities

European Medicines Agency, Food And Drug Administration

Plan to share IPD

Yes

IPD plan description

AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information. To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/ For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 2

1. Diagnosis of histologically or cytologically confirmed unresectable metastatic colorectal cancer (mCRC).
2. Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

Exclusion criteria 4

1. Harbor the BRAF V600E mutation.
2. dMMR+/MSI-H.
3. Progressed on only one first-line (1L) systemic treatment of combination chemotherapy in the metastatic setting with or without targeted therapy.
4. 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.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. Objective Response as assessed by the investigator
2. Progression Free Survival (PFS) as assessed by the investigator

Secondary endpoints 3

1. Duration of Response (DOR) as assessed by the investigator
2. Overall Survival (OS)
3. Best Overall Response (BOR) as assessed by the investigator

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Comparator 4

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

AbbVie Deutschland GmbH & Co. KG

Sponsor organisation

AbbVie Deutschland GmbH & Co. KG

Address

Knollstrasse

City

Ludwigshafen Am Rhein

Postcode

67061

Country

Germany

Scientific contact point

Organisation

AbbVie Deutschland GmbH & Co. KG

Contact name

Global Clinical Trials Helpdesk

Public contact point

Organisation

AbbVie Deutschland GmbH & Co. KG

Contact name

Global Clinical Trials Helpdesk

Third parties 6

Locations

3 EU/EEA countries · 19 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 47 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

6 submissions — initial application plus substantial / non-substantial modifications