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 (AndroMETa-CRC)

AbbVie

Status and phase

Enrolling

Phase 2

Conditions

Metastatic Colorectal Cancer

Treatments

Drug: Oxaliplatin

Drug: Panitumumab

Drug: Bevacizumab

Drug: Fluorouracil

Drug: Telisotuzumab Adizutecan

Drug: Leucovorin

Study type

Interventional

Funder types

Industry

Identifiers

NCT06820463

M24-533

EU CT (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

390 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

390 participants in 8 patient groups

Substudy 1: Dose Escalation Telisotuzumab Adizutecan

Experimental group

Description:

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.

Treatment:

Drug: Leucovorin

Drug: Telisotuzumab Adizutecan

Drug: Fluorouracil

Drug: Bevacizumab

Drug: Oxaliplatin

Substudy 1: Dose Expansion Telisotuzumab Adizutecan High Dose

Experimental group

Description:

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.

Treatment:

Drug: Leucovorin

Drug: Telisotuzumab Adizutecan

Drug: Fluorouracil

Drug: Bevacizumab

Drug: Oxaliplatin

Substudy 1: Dose Expansion Telisotuzumab Adizutecan Low Dose

Experimental group

Description:

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.

Treatment:

Drug: Leucovorin

Drug: Telisotuzumab Adizutecan

Drug: Fluorouracil

Drug: Bevacizumab

Drug: Oxaliplatin

Substudy 1: Dose Expansion Compatator

Experimental group

Description:

Participants will receive a fixed dose of FOLFOX and bevacizumab as part of the approximately 6 year study duration.

Treatment:

Drug: Leucovorin

Drug: Fluorouracil

Drug: Bevacizumab

Drug: Oxaliplatin

Substudy 2: Dose Escalation Telisotuzumab Adizutecan

Experimental group

Description:

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.

Treatment:

Drug: Leucovorin

Drug: Telisotuzumab Adizutecan

Drug: Fluorouracil

Drug: Panitumumab

Substudy 2: Dose Expansion Telisotuzumab Adizutecan High Dose

Experimental group

Description:

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.

Treatment:

Drug: Leucovorin

Drug: Telisotuzumab Adizutecan

Drug: Fluorouracil

Drug: Panitumumab

Substudy 2: Dose Expansion Telisotuzumab Adizutecan Low Dose

Experimental group

Description:

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.

Treatment:

Drug: Leucovorin

Drug: Telisotuzumab Adizutecan

Drug: Fluorouracil

Drug: Panitumumab

Substudy 2: Dose Expansion Compatator

Experimental group

Description:

Participants will receive a fixed dose of FOLFOX and panitumumab as part of the approximately 6 year study duration.

Treatment:

Drug: Leucovorin

Drug: Fluorouracil