Clinical trial NCT06820463: 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
Official title: A Phase 2, Open-Label, Randomized, Master Protocol Study to Evaluate Safety and Efficacy of Multiple Treatment Combinations With Telisotuzumab Adizutecan in Subjects With Metastatic Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Metastatic Colorectal Cancer
Keywords: Metastatic Colorectal Cancer
AndroMETa-CRC-533
Telisotuzumab Adizutecan
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2025-02-11
Enrollment: 390
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Objective Response (OR) as Assessed by the Investigator confirmed complete response (CR) or partial response (PR) as assessed by the investigator per response evaluation criteria in solid tumors (RECIST), version 1.1.
timeFrame: Up to 24 Weeks
measure: Number of Participants with Adverse Events (AE)s
timeFrame: Up to Approximately 6 Years
Secondary outcomes:
measure: Progression-Free Survival (PFS) as Assessed by the Investigator
timeFrame: Up to 22 Months
measure: Duration of Response (DOR) as Assessed by the investigator
timeFrame: Up to 14 Months
measure: Overall Survival (OS)
timeFrame: Up to Approximately 6 Years
measure: Disease Control (DC) as Assessed by the Investigator
timeFrame: Up to Approximately 6 Years
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale New Haven Hospital /ID# 270565
state: Connecticut
city: Hinsdale
country: United States
facility: Hope And Healing Cancer Services /ID# 271562
state: Illinois
city: Omaha
country: United States
facility: Nebraska Cancer Specialists - Omaha - Wright Street /ID# 271646
state: Nebraska
city: Heidelberg
country: Australia
facility: Austin Health /ID# 270692
state: Victoria
city: Haifa
country: Israel
facility: Rambam Health Care Campus /ID# 268006
state: H_efa
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center /ID# 268010
state: Tel-Aviv
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center /ID# 268009
city: Jerusalem
country: Israel
facility: Hadassah Medical Center-Hebrew University /ID# 268007
city: Petah Tikva
country: Israel
facility: Rabin Medical Center /ID# 268008
city: Kashiwa-shi
country: Japan
facility: National Cancer Center Hospital East /ID# 270114
state: Chiba
city: Kawasaki-shi
country: Japan
facility: St. Marianna University Hospital /ID# 270111
state: Kanagawa
city: Chuo-Ku
country: Japan
facility: National Cancer Center Hospital /ID# 270112
state: Tokyo
city: Rio Piedras
country: Puerto Rico
facility: Pan American Center for Oncology Trials /ID# 268809
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 269724
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital /ID# 270835
city: Taipei City
country: Taiwan
facility: Taipei Veterans General Hospital /ID# 269718
city: Taoyuan City
country: Taiwan
facility: Linkou Chang Gung Memorial Hospital /ID# 269725
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: