ABBV-400 vs Standard Treatment for Colorectal Cancer

(AndroMETa-CRC- Trial)

Recruiting at 66 trial locations

Overseen By ABBVIE CALL CENTER

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: AbbVie

Must not be taking: C-MET antibodies, ADCs

Disqualifiers: Allergy to bevacizumab, Active infection, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

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

Compensation: Varies

Number of Visits: Unknown

460 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new drug, telisotuzumab adizutecan (also known as ABBV-400), for individuals with a specific type of advanced colorectal cancer unresponsive to standard treatments. It compares different doses of this new drug to usual treatment options. The trial aims to assess the drug's effectiveness and potential side effects. Individuals with high levels of a certain protein (c-Met) in their cancer, who have not found success with other treatments, might be suitable for this study. Participants must attend regular monitoring visits throughout the trial. As a Phase 3 trial, this study represents the final step before potential FDA approval, offering participants a chance to contribute to the development of a promising new treatment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that telisotuzumab adizutecan is generally well-tolerated. Early results from an initial study indicated that patients can handle its safety profile, with manageable side effects. These findings are promising, particularly for treating colorectal cancer with high c-Met expression.

It is important to remember that this treatment remains under study, so researchers closely monitor any side effects. Trial participants will have regular check-ins for medical assessments and side effect monitoring to ensure their safety. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about ABBV-400 because it targets colorectal cancer differently from current treatments. Unlike the standard chemotherapy and targeted therapies, ABBV-400 uses a novel approach by delivering a potent cytotoxic agent directly to cancer cells via the telisotuzumab adizutecan antibody. This targeted delivery aims to increase the treatment's effectiveness while minimizing damage to healthy cells, potentially leading to fewer side effects. This unique mechanism of action could offer a promising new option for patients who have limited success with existing therapies.

What evidence suggests that this trial's treatments could be effective for colorectal cancer?

Research has shown that telisotuzumab adizutecan, one of the treatments in this trial, may help treat colorectal cancer, particularly in patients with high levels of the protein c-Met. Studies have found that patients respond better and experience longer periods without cancer progression compared to standard treatments. This drug targets c-Met, which can promote cancer growth, and appears effective when this protein is abundant. Early data suggests that patients taking telisotuzumab adizutecan might achieve better results than with some other treatments. Overall, the evidence supports its potential effectiveness for certain colorectal cancer patients. Participants in this trial will receive either telisotuzumab adizutecan or standard treatment, allowing for a direct comparison of outcomes. ^{1 2 4 5 6}

Who Is on the Research Team?

ABBVIE INC.

Principal Investigator

AbbVie

Are You a Good Fit for This Trial?

This trial is for adults with a specific type of advanced colorectal cancer that has resisted previous treatments and shows c-Met over-expression. Participants should have measurable disease, an expected survival of at least 12 weeks, and be in good physical condition with an ECOG performance status of 0 or 1.

Inclusion Criteria

Life expectancy >= 12 weeks per investigator assessment

Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1.

I am fully active or restricted in physically strenuous activity but can do light work.

Exclusion Criteria

History of allergic reactions or hypersensitivity to bevacizumab or any of its excipients, or to compounds similar to trifluridine/tipiracil

I have been treated with a c-MET targeting therapy before.

I do not have any current infections.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Stage 1

Participants receive intravenously (IV) infused ABBV-400 dose A or B

Up to 4 years

Regular visits at approved institutions

Treatment Stage 2

Participants receive the optimal dose of IV infused ABBV-400 or LONSURF oral tablets plus IV infused bevacizumab

Up to 4 years

Regular visits at approved institutions

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• ABBV-400
• Bevacizumab
• Trifluridine/Tipiracil

Trial Overview The study compares the effects and safety of ABBV-400 given through IV to standard oral medication LONSURF plus IV Bevacizumab in two stages. Initially, different doses of ABBV-400 are tested; then the best dose is compared to the standard treatment.

How Is the Trial Designed?

Group I: Stage 2: Telisotuzumab Adizutecan Optimal Dose Experimental Treatment 1 Intervention

Participants will receive the optimal dose of telisotuzumab adizutecan, as part of the approximately 4 year study duration.

Group II: Stage 2: Standard of Care (SOC) Experimental Treatment 2 Interventions

Participants will receive the SOC, as part of the approximately 4 year study duration.

Group III: Stage 1: Telisotuzumab Adizutecan Dose B Experimental Treatment 1 Intervention

Participants will receive telisotuzumab adizutecan dose B, as part of the approximately 4 year study duration.

Group IV: Stage 1: Telisotuzumab Adizutecan Dose A Experimental Treatment 1 Intervention

Participants will receive telisotuzumab adizutecan dose A, as part of the approximately 4 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

Published Research Related to This Trial

A phase III study found that the combination of atezolizumab and cobimetinib did not show improved effectiveness compared to standard therapy (regorafenib) in patients with inoperable, locally advanced, or metastatic colorectal cancer.

The overall survival for patients receiving the combination treatment was 8.9 months, slightly higher than the 8.5 months for those on standard therapy, but the response rates were very similar at 2.7% for the combination versus 2.2% for regorafenib.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Drug Duo Disappoints in Colorectal Cancer. [2019]

Bevacizumab, a monoclonal antibody that blocks vascular endothelial growth factor, significantly improved response rates and survival in metastatic colorectal cancer when combined with chemotherapy, based on a randomized phase III trial.

Cetuximab, which inhibits the epidermal growth factor receptor, demonstrated a 22.5% response rate and prolonged progression-free survival in irinotecan-refractory patients, highlighting its effectiveness as a treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Which role do new therapeutic options play in palliative care of colorectal cancer?]. Verbeek, W., Graeven, U.[2018]

In a phase II trial involving 36 patients with irinotecan-refractory metastatic colorectal cancer, the combination of cetuximab, bevacizumab, and irinotecan (CBI) showed a statistically significant improvement in overall survival (OS) compared to cetuximab and irinotecan alone (CI), with median OS of 19.7 months versus 10.2 months.

Although there was no significant difference in progression-free survival (PFS) between the two treatment groups, the study suggests that further investigation into the CBI combination is warranted due to the observed benefits in overall survival.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cetuximab and Irinotecan With or Without Bevacizumab in Refractory Metastatic Colorectal Cancer: BOND-3, an ACCRU Network Randomized Clinical Trial. Lipsyc-Sharf, M., Ou, FS., Yurgelun, MB., et al.[2022]

Infusional 5-fluorouracil (5-FU) is more effective and safer than bolus 5-FU in treating metastatic colorectal cancer (mCRC), while capecitabine offers similar efficacy with improved safety compared to 5-FU when combined with oxaliplatin.

The combination of chemotherapy with biologic agents like bevacizumab and cetuximab enhances treatment efficacy, and the approach to mCRC is shifting towards individualized therapy based on factors like KRAS mutational status.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Seeing the forest through the trees: a systematic review of the safety and efficacy of combination chemotherapies used in the treatment of metastatic colorectal cancer. Bekaii-Saab, T., Wu, C.[2018]

Combination therapy using irinotecan or oxaliplatin with infusional 5-FU and folinic acid has increased response rates to about 50% and extended median overall survival to 20 months in patients with metastatic colorectal cancer.

Monoclonal antibodies like bevacizumab and cetuximab have shown to significantly enhance treatment outcomes, with bevacizumab extending survival by over 4 months compared to chemotherapy alone, and cetuximab being effective after progression with irinotecan.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[New therapy options in colorectal carcinoma]. Folprecht, G., Köhne, CH.[2018]

Folfox4 has become the new standard treatment for colorectal cancer, particularly after the Mosaic study, while oral fluoropyrimidines like capecitabine offer effective alternatives to traditional intravenous treatments.

In stage II colon cancer, chemotherapy may not be necessary for low-risk tumors, but high-risk tumors should consider adjuvant treatments like Folfox4 or fluoropyrimidine combinations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Adjuvant treatment of colorectal cancer]. Segura, C., Afchain, P., de Gramont, A., et al.[2018]

In a study of 63 patients with KRAS wild-type metastatic colorectal cancer, the combination of irinotecan, bevacizumab, and cetuximab/panitumumab as a 4th-line treatment was found to be safe and well tolerated, with a toxicity profile consistent with the individual drugs.

The treatment resulted in a median progression-free survival of 6.1 months and a median overall survival of 11.9 months, indicating a significant level of disease control in patients who had already undergone multiple lines of therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dual Inhibition of EGFR and VEGF in Heavily Pretreated Patients with Metastatic Colorectal Cancer. Larsen, FO., Markussen, A., Nielsen, D., et al.[2018]

In a study involving 27 heavily pretreated patients with metastatic colorectal cancer, the combination of irinotecan, cetuximab, and bevacizumab was well tolerated and resulted in a progression-free survival (PFS) of 8.3 months and a median overall survival (mOS) of 12.0 months.

The addition of bevacizumab to the treatment regimen showed a trend towards improved outcomes in patients without KRAS mutations, suggesting that this combination therapy may be particularly effective for certain patient subgroups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bevacizumab in combination with cetuximab and irinotecan after failure of cetuximab and irinotecan in patients with metastatic colorectal cancer. Larsen, FO., Pfeiffer, P., Nielsen, D., et al.[2018]

Citations

1. news.abbvie.com news.abbvie.com/2025-10-13-AbbVie-to-Present-New-Data-at-ESMO-2025-Reinforcing-Leadership-in-Advancing-Targeted-Therapies-for-Solid-Tumors

AbbVie to Present New Data at ESMO 2025 Reinforcing ... New data from telisotuzumab adizutecan (Temab-A) and ABBV-706 across pancreatic, colorectal, and solid tumors, highlight progress in ...

2. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.TPS3635

Temab-A) monotherapy vs trifluridine/tipiracil plus ... Colorectal Cancer January 2024. Real-world analysis of patient characteristics and outcomes among patients with metastatic colorectal cancer ...

3. onclive.com onclive.com/view/effectively-targeting-c-met-in-colorectal-cancer-is-becoming-a-reality-with-novel-approaches

Effectively Targeting c-Met in Colorectal Cancer Is ... Telisotuzumab adizutecan shows potential in CRC, with improved response rates and progression-free survival, especially in high c-Met expression ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06820463

NCT06820463 | A Study to Evaluate the Adverse Events ... The purpose of this study is to assess adverse events and change in disease activity when telisotuzumab adizutecan is given in combination with oxaliplatin, ...

5. asco.org asco.org/abstracts-presentations/ABSTRACT485886

Temab-A) monotherapy vs trifluridine/tipiracil plus ... We describe a phase 3 study comparing Temab-A monotherapy with the standard of care (trifluridine/tipiracil plus bevacizumab) in patients with refractory mCRC.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06820463

NCT06820463 | A Study to Evaluate the Adverse Events ... The purpose of this study is to assess adverse events and change in disease activity when telisotuzumab adizutecan is given in combination with oxaliplatin, ...