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A Study to Evaluate the Adverse Events, and Efficacy of Intravenous (IV) of Telisotuzumab Adizutecan in Combination With IV Oxaliplatin, Fluorouracil, Folinic Acid/Leucovorin, Bevacizumab, Panitumumab in Adult Participants With Metastatic Colorectal Cancer

Purpose

CRC is the third most common type of cancer diagnosed worldwide with developed countries at highest risk. The purpose of this study is to assess adverse events and change in disease activity when telisotuzumab adizutecan is given in combination with oxaliplatin, fluorouracil (5FU), leucovorin (LV) (FOLFOX), and bevacizumab or panitumumab. Telisotuzumab adizutecan is an investigational drug being developed for the treatment of mCRC. Fluorouracil and leucovorin are drugs approved for the treatment of mCRC. This study will be divided into two stages, with the first stage treating participants with increasing doses of telisotuzumab adizutecan with FOLFOX and bevacizumab or 5FU/LV and panitumumab until the dose reached is tolerable and expected to be efficacious. Participants will then be randomized into 3 groups called treatment arms where one group will receive one of two optimized doses of telisotuzumab adizutecan from the dose escalation phase with FOLFOX and bevacizumab or 5FU/LV and panitumumab, or a comparator of FOLFOX and bevacizumab or panitumumab. Approximately 390 adult participants with mCRC will be enrolled in the study in 100 sites worldwide. In the dose escalation stage participants will be treated with increasing intravenous (IV) doses of telisotuzumab adizutecan with FOLFOX and bevacizumab or 5FU/LV and panitumumab until the dose reached is tolerable and expected to be efficacious. In the dose optimization stage participants will be receive FOLFOX or receive 5FU/LV, but with one of two optimized doses of telisotuzumab adizutecan, or a comparator of FOLFOX and bevacizumab/pantitumumab. The study will run for a duration of approximately 6 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.

Condition

Metastatic Colorectal Cancer

Eligibility

Eligible Ages: Over 18 Years
Eligible Sex: All
Accepts Healthy Volunteers: No

Inclusion Criteria

Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. - Laboratory values meeting the criteria within the protocol. - Has measurable disease per response evaluation criteria in solid tumors (RECIST) v1.1.

Exclusion Criteria

Prior systemic regimen containing c-Met targeting agent(s) (e.g., antibody, antibody drug conjugate, bispecific) and/or any topoisomerase inhibitor(s) (e.g., irinotecan). - History of other malignancies within 5 years prior to screening, except for malignancies with a negligible risk of metastasis or death.

Study Design

Phase: Phase 2
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Masking: None (Open Label)

Arm Groups

Arm	Description	Assigned Intervention
Experimental Substudy 1: Dose Escalation Telisotuzumab Adizutecan	Participants will receive various doses of telisotuzumab adizutecan in combination with a fixed dose of fluorouracil, leucovorin, and oxaliplatin (FOLFOX) and bevacizumab as part of the approximately 6 year study duration.	Drug: Telisotuzumab Adizutecan Intravenous (IV) Infusion Drug: Fluorouracil IV Infusion; IV Injection Drug: Oxaliplatin IV Infusion Drug: Leucovorin IV Infusion; IV Injection Drug: Bevacizumab IV Infusion
Experimental Substudy 1: Dose Expansion Telisotuzumab Adizutecan High Dose	Participants will receive the high dose of telisotuzumab adizutecan determined in the dose expansion arm in combination with a fixed dose of FOLFOX and bevacizumab as part of the approximately 6 year study duration.	Drug: Telisotuzumab Adizutecan Intravenous (IV) Infusion Drug: Fluorouracil IV Infusion; IV Injection Drug: Oxaliplatin IV Infusion Drug: Leucovorin IV Infusion; IV Injection Drug: Bevacizumab IV Infusion
Experimental Substudy 1: Dose Expansion Telisotuzumab Adizutecan Low Dose	Participants will receive the low dose of telisotuzumab adizutecandetermined in the dose expansion arm in combination with a fixed dose of FOLFOX and bevacizumab as part of the approximately 6 year study duration.	Drug: Telisotuzumab Adizutecan Intravenous (IV) Infusion Drug: Fluorouracil IV Infusion; IV Injection Drug: Oxaliplatin IV Infusion Drug: Leucovorin IV Infusion; IV Injection Drug: Bevacizumab IV Infusion
Experimental Substudy 1: Dose Expansion Compatator	Participants will receive a fixed dose of FOLFOX and bevacizumab as part of the approximately 6 year study duration.	Drug: Fluorouracil IV Infusion; IV Injection Drug: Oxaliplatin IV Infusion Drug: Leucovorin IV Infusion; IV Injection Drug: Bevacizumab IV Infusion
Experimental Substudy 2: Dose Escalation Telisotuzumab Adizutecan	Participants will receive various doses of telisotuzumab adizutecan in combination with a fixed dose of fluorouracil (5-FU) and leucovorin (LV) and panitumumab as part of the approximately 6 year study duration.	Drug: Telisotuzumab Adizutecan Intravenous (IV) Infusion Drug: Fluorouracil IV Infusion; IV Injection Drug: Leucovorin IV Infusion; IV Injection Drug: Panitumumab IV Infusion
Experimental Substudy 2: Dose Expansion Telisotuzumab Adizutecan High Dose	Participants will receive the high dose of telisotuzumab adizutecan determined in the dose expansion arm in combination with a fixed dose of 5-FU/LV and panitumumab as part of the approximately 6 year study duration.	Drug: Telisotuzumab Adizutecan Intravenous (IV) Infusion Drug: Fluorouracil IV Infusion; IV Injection Drug: Leucovorin IV Infusion; IV Injection Drug: Panitumumab IV Infusion
Experimental Substudy 2: Dose Expansion Telisotuzumab Adizutecan Low Dose	Participants will receive the low dose of telisotuzumab adizutecan determined in the dose expansion arm in combination with a fixed dose of 5-FU/LV and panitumumab as part of the approximately 6 year study duration.	Drug: Telisotuzumab Adizutecan Intravenous (IV) Infusion Drug: Fluorouracil IV Infusion; IV Injection Drug: Leucovorin IV Infusion; IV Injection Drug: Panitumumab IV Infusion
Experimental Substudy 2: Dose Expansion Compatator	Participants will receive a fixed dose of FOLFOX and panitumumab as part of the approximately 6 year study duration.	Drug: Fluorouracil IV Infusion; IV Injection Drug: Oxaliplatin IV Infusion Drug: Leucovorin IV Infusion; IV Injection Drug: Panitumumab IV Infusion

Recruiting Locations

Yale New Haven Hospital /ID# 270565
New Haven, Connecticut 06510

Hope And Healing Cancer Services /ID# 271562
Hinsdale, Illinois 60521

Saint Luke's Hospital of Kansas City /ID# 270633
Kansas City, Missouri 64111

Nebraska Cancer Specialists - Omaha - Wright Street /ID# 271646
Omaha, Nebraska 68130

Pan American Center for Oncology Trials /ID# 268809
Rio Piedras, Puerto Rico 00935

More Details

NCT ID: NCT06820463
Status: Recruiting
Sponsor: AbbVie

Study Contact

ABBVIE CALL CENTER
844-663-3742
abbvieclinicaltrials@abbvie.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.