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
- 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.
- Acronym
- AndroMETa-CRC
- Short title
- 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
- Control arm
- Open label
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Completion date
- 2028-04-01
- First posted
- 2025-02-11
- Registry last updated
- 2026-08-25
- Primary completion date
- 2028-03-01
- Start date
- 2025-04-24
- Participants
- Participant count basis
- Estimated
- Planned participants
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- AbbVie
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT06820463
- ClinicalTrials.gov ID
- NCT06820463
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Treatment
- Masking
- No masking
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
OR is defined as confirmed CR or PR as assessed by the investigator per RECIST, version 1.1.
Number of Participants with Adverse Events (AE)s
Timeframe: Up to Approximately 6 Years
An adverse event is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
Progression-Free Survival (PFS) as Assessed by the Investigator
Timeframe: Up to 22 Months
PFS is defined as the time from the first dose of study treatment to the first occurrence of radiographic progression based on RECIST version 1.1 as determined by the investigator or death from any cause, whichever occurs earlier.
Duration of Response (DOR) as Assessed by the investigator
Timeframe: Up to 14 Months
DOR is defined as the time from the first documented CR or PR to the first occurrence of radiographic progression per RECIST v1.1 as determined by the investigator or death from any cause, whichever occurs first.
Overall Survival (OS)
Timeframe: Up to Approximately 6 Years
OS is defined as the time from first dose of study treatment to the event of death from any cause.
Disease Control (DC) as Assessed by the Investigator
Timeframe: Up to Approximately 6 Years
DC is defined as best overall response of confirmed CR or confirmed PR, or stable disease (SD) based on RECIST, version 1.1 as determined by the investigator.
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 18 Years
- Healthy volunteers
- No
- 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.
- 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.
- City of Hope National Medical Center /ID# 270255Duarte, United StatesRecruiting
- UCLA - Santa Monica /ID# 270621Santa Monica, United StatesRecruiting
- Yale New Haven Hospital /ID# 270565New Haven, United StatesRecruiting
- AdventHealth Orlando /ID# 270789Orlando, United StatesRecruiting
- Northwest Georgia Oncology Centers /ID# 270245Marietta, United StatesRecruiting
- University of Chicago Medical Center /ID# 271688Chicago, United StatesRecruiting
- Hope And Healing Cancer Services /ID# 271562Hinsdale, United StatesRecruiting
- Dana-Farber Cancer Institute /ID# 270624Boston, United StatesRecruiting
- University Of Michigan /ID# 270790Ann Arbor, United StatesRecruiting
- Saint Lukes Hospital of Kansas City /ID# 270633Kansas City, United StatesRecruiting
- Nebraska Cancer Specialists - Omaha - Wright Street /ID# 271646Omaha, United StatesRecruiting
- University of North Carolina Medical Center /ID# 267786Chapel Hill, United StatesRecruiting
- Oncology Hematology Care - Eastgate /ID# 271493Cincinnati, United StatesRecruiting
- Texas Oncology - Austin Midtown /ID# 271354Austin, United StatesRecruiting
- Texas Oncology - Deke Slayton Cancer Center /ID# 271355Webster, United StatesRecruiting
- Virginia Cancer Specialists - Fairfax /ID# 271351Fairfax, United StatesRecruiting
- University Of Washington-Fred Hutchinson Cancer Center - Seattle /ID# 271298Seattle, United StatesRecruiting
- Macquarie University /ID# 271514Sydney, AustraliaRecruiting
- Mater Misericordiae /ID# 270694South Brisbane, AustraliaRecruiting
- The Queen Elizabeth Hospital /ID# 270693Woodville South, AustraliaRecruiting
- Austin Health /ID# 270692Heidelberg, AustraliaRecruiting
- One Clinical Research /ID# 270695Nedlands, AustraliaRecruiting
- Medizinische Universitaet Wien /ID# 268872Vienna, AustriaRecruiting
- Hospital Sao Rafael /ID# 271681Salvador, BrazilRecruiting
- Oncosite - Centro de Pesquisa Clinica em Oncologia /ID# 270147Ijuí, BrazilRecruiting
And 40 more, listed on the interactive page.
Other registry identifiers
- 2024-512981-33-00
Related records
Drugs (6)
Lead sponsors (1)
Conditions (2)
- Colorectal cancer Primary condition
- Colorectal neoplasm