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

Part of paid clinical trials in Duarte, California.

Sponsor
AbbVie
Study ID
NCT06820463
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Metastatic Colorectal Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Telisotuzumab Adizutecan — DRUG
    Intravenous (IV) Infusion
  • Fluorouracil — DRUG
    IV Infusion; IV Injection
  • Oxaliplatin — DRUG
    IV Infusion
  • Leucovorin — DRUG
    IV Infusion; IV Injection
  • Bevacizumab — DRUG
    IV Infusion
  • Panitumumab — DRUG
    IV Infusion

Study Details

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.

Key Dates

Start date
Apr 24, 2025
Status verified
Jun 2026
Primary completion
Mar 31, 2028
Completion
Apr 30, 2028

Study Design

Enrollment
390 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

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 ]

Central Contacts

Locations (12)

FacilityCityStateZIPSite coordinators
City of Hope National Medical Center /ID# 270255DuarteCalifornia91010-
UCLA - Santa Monica /ID# 270621Santa MonicaCalifornia90404-
Yale New Haven Hospital /ID# 270565New HavenConnecticut06510-
University of Chicago Medical Center /ID# 271688ChicagoIllinois60637-
Hope And Healing Cancer Services /ID# 271562HinsdaleIllinois60521-
Dana-Farber Cancer Institute /ID# 270624BostonMassachusetts02215-
Saint Lukes Hospital of Kansas City /ID# 270633Kansas CityMissouri64111-
Nebraska Cancer Specialists - Omaha - Wright Street /ID# 271646OmahaNebraska68130-
University of North Carolina Medical Center /ID# 267786Chapel HillNorth Carolina27514-
Oncology Hematology Care - Eastgate /ID# 271493CincinnatiOhio45245-
Texas Oncology - Austin Midtown /ID# 271354AustinTexas78705-
Texas Oncology - Deke Slayton Cancer Center /ID# 271355WebsterTexas77598-

Find similar trials in Duarte, CA

By research site
City of Hope National Medical Center· Duarte, CAUCLA - Santa Monica· Santa Monica, CAYale New Haven Hospital· New Haven, CTUniversity of Chicago Medical Center· Chicago, ILHope And Healing Cancer Services· Hinsdale, ILDana-Farber Cancer Institute· Boston, MA

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