Recruiting
Phase 2

Telisotuzumab & Oxaliplatin

Sponsor:

AbbVie

Code:

NCT06820463

Conditions

Metastatic Colorectal Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Telisotuzumab Adizutecan

Fluorouracil

Oxaliplatin

Leucovorin

Bevacizumab

Study Details

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.

Conditions

Metastatic Colorectal Cancer

Study ID

NCT06820463

Start date

Apr 24, 2025

Status verified date

Oct, 2026

Completion date

Apr, 2028

Anticipated

Primary completion date

Mar, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

390 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

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.

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.

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.

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.

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.

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.

Interventions

Telisotuzumab Adizutecan

Intravenous (IV) Infusion

Fluorouracil

IV Infusion; IV Injection

Oxaliplatin

IV Infusion

Leucovorin

IV Infusion; IV Injection

Bevacizumab

IV Infusion

Panitumumab

IV Infusion

Primary outcome 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. [ Time Frame: Up to 24 Weeks ]
  • Number of Participants with Adverse Events (AE)s [ Time Frame: Up to Approximately 6 Years ]

Central Contacts and Locations

Central contacts

ABBVIE CALL CENTER

844-663-3742abbvieclinicaltrials@abbvie.com

Locations

City of Hope National Medical Center /ID# 270255

Recruiting

Duarte, California, United States, 91010

UCLA - Santa Monica /ID# 270621

Recruiting

Santa Monica, California, United States, 90404

Yale New Haven Hospital /ID# 270565

Recruiting

New Haven, Connecticut, United States, 06510

AdventHealth Orlando /ID# 270789

Recruiting

Orlando, Florida, United States, 32803

Northwest Georgia Oncology Centers /ID# 270245

Recruiting

Marietta, Georgia, United States, 30060

University of Chicago Medical Center /ID# 271688

Recruiting

Chicago, Illinois, United States, 60637

Hope And Healing Cancer Services /ID# 271562

Recruiting

Hinsdale, Illinois, United States, 60521

Dana-Farber Cancer Institute /ID# 270624

Recruiting

Boston, Massachusetts, United States, 02215

University Of Michigan /ID# 270790

Recruiting

Ann Arbor, Michigan, United States, 48109-5000

Saint Lukes Hospital of Kansas City /ID# 270633

Recruiting

Kansas City, Missouri, United States, 64111

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

Recruiting

Omaha, Nebraska, United States, 68130

University of North Carolina at Chapel Hill /ID# 267786

Recruiting

Chapel Hill, North Carolina, United States, 27514

Oncology Hematology Care - Eastgate /ID# 271493

Recruiting

Cincinnati, Ohio, United States, 45245

Texas Oncology - Austin Midtown /ID# 271354

Recruiting

Austin, Texas, United States, 78705

Texas Oncology - Deke Slayton Cancer Center /ID# 271355

Recruiting

Webster, Texas, United States, 77598

Virginia Cancer Specialists - Fairfax /ID# 271351

Recruiting

Fairfax, Virginia, United States, 22031

University Of Washington /ID# 271298

Recruiting

Seattle, Washington, United States, 98109

Arthur J.E Child Comprehensive Cancer Centre /ID# 269809

Recruiting

Calgary, Alberta, Canada, T2N 5G2

Cross Cancer Institute. /ID# 272711

Recruiting

Edmonton, Alberta, Canada, T6G 1Z2

London Health Sciences Centre - Victoria Hospital & Children's Hospital /ID# 270680

Recruiting

London, Ontario, Canada, N6A 5W9

Princess Margaret Cancer Centre /ID# 268715

Recruiting

Toronto, Ontario, Canada, M5G 2M9

Universite de Montreal - Hopital Maisonneuve-Rosemont /ID# 271368

Recruiting

Montreal, Quebec, Canada, H1T 2M4

More Information

Sponsor

AbbVie

Last update posted

Oct 15, 2026

Last verified

Oct, 2026

Keywords

  • Metastatic Colorectal Cancer
  • AndroMETa-CRC-533
  • Telisotuzumab Adizutecan

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-18. This information was provided to ClinicalTrials.gov by AbbVie on 2026-10-15. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.