Telisotuzumab Adizutecan + Combination Therapy for Colorectal Cancer

(AndroMETa-CRC Trial)

Recruiting at 9 trial locations

Overseen By ABBVIE CALL CENTER

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: AbbVie

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

390 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

ABBVIE INC.

Principal Investigator

AbbVie

Eligibility Criteria

This trial is for adults with metastatic colorectal cancer (mCRC) who have measurable disease, are in good physical condition (ECOG status of 0 or 1), and meet specific laboratory criteria. It's not suitable for those who don't fit these requirements.

Inclusion Criteria

Has measurable disease per response evaluation criteria in solid tumors (RECIST) v1.1.

Laboratory values meeting the criteria within the protocol

I am fully active or can carry out light work.

Exclusion Criteria

I haven't had any other cancers in the last 5 years, except for those unlikely to spread.

I have been treated with drugs targeting c-Met or topoisomerase inhibitors.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive increasing doses of telisotuzumab adizutecan with FOLFOX and bevacizumab or 5FU/LV and panitumumab until a tolerable and efficacious dose is reached.

Up to 24 weeks

Regular visits (in-person)

Dose Optimization

Participants receive one of two optimized doses of telisotuzumab adizutecan with FOLFOX and bevacizumab or 5FU/LV and panitumumab, or a comparator of FOLFOX and bevacizumab or panitumumab.

Up to 22 months

Regular visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 6 years

Regular visits (in-person)

Treatment Details

Interventions

• Telisotuzumab Adizutecan

Trial Overview The study tests a new drug, Telisotuzumab Adizutecan, combined with chemotherapy drugs FOLFOX and either Bevacizumab or Panitumumab. Participants will first receive increasing doses to find the safest effective amount, then be randomly assigned to treatment groups.

Participant Groups

Group I: Substudy 2: Dose Expansion Telisotuzumab Adizutecan Low Dose Experimental Treatment 4 Interventions

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.

Group II: Substudy 2: Dose Expansion Telisotuzumab Adizutecan High Dose Experimental Treatment 4 Interventions

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.

Group III: Substudy 2: Dose Expansion Compatator Experimental Treatment 4 Interventions

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

Group IV: Substudy 2: Dose Escalation Telisotuzumab Adizutecan Experimental Treatment 4 Interventions

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.

Group V: Substudy 1: Dose Expansion Telisotuzumab Adizutecan Low Dose Experimental Treatment 5 Interventions

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.

Group VI: Substudy 1: Dose Expansion Telisotuzumab Adizutecan High Dose Experimental Treatment 5 Interventions

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.

Group VII: Substudy 1: Dose Expansion Compatator Experimental Treatment 4 Interventions

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

Group VIII: Substudy 1: Dose Escalation Telisotuzumab Adizutecan Experimental Treatment 5 Interventions

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.

Who Is Running the Clinical Trial?

AbbVie

Lead Sponsor

Trials

1,079

Recruited

535,000+

Founded

2013

Headquarters

North Chicago, USA

Known For

Immunology treatments

Top Products

Humira (adalimumab), Skyrizi (risankizumab), Rinvoq (upadacitinib)

Dr. Roopal Thakkar

AbbVie

Chief Medical Officer since 2023

MD from Wayne State University School of Medicine

Robert A. Michael

AbbVie

Chief Executive Officer

Bachelor's degree in Finance from the University of Illinois