140 Participants Needed

Telisotuzumab Adizutecan for Colorectal Cancer

Recruiting at 29 trial locations
AC
Overseen ByABBVIE CALL CENTER
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: AbbVie
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of a new drug, telisotuzumab adizutecan, in treating colorectal cancer (CRC) compared to the standard treatment. Participants will be divided into two groups: one will receive the new drug, while the other will receive the usual treatment. Eligible participants must have a colorectal cancer diagnosis, have completed certain chemotherapy treatments, and show no visible signs of the disease based on recent scans. Participants must commit to regular hospital or clinic visits for check-ups and tests. This study could lead to improved treatment options for CRC in the future. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of people.

Do I need to stop my current medications for this trial?

The trial information does not specify if you need to stop 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 safe. In early studies, patients who used this treatment experienced positive outcomes and managed it well, suggesting safety for others. However, some side effects were reported, as with many treatments. It is important to remember that this drug remains under testing, allowing researchers to learn more about its safety. Anyone considering joining a trial should discuss the possible risks and benefits with their doctor.12345

Why do researchers think this study treatment might be promising?

Telisotuzumab Adizutecan is unique because it targets a specific protein called c-Met, which is often overexpressed in colorectal cancer cells. This targeted approach is different from standard chemotherapy treatments, which typically attack all rapidly dividing cells, cancerous or not. By focusing on the c-Met protein, Telisotuzumab Adizutecan has the potential to more precisely attack cancer cells while sparing healthy ones, potentially leading to fewer side effects. Researchers are excited because this could mean more effective treatment options with less collateral damage to healthy tissue.

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

Research has shown that telisotuzumab adizutecan, which participants in this trial may receive as monotherapy, may effectively treat colorectal cancer, particularly in patients with high levels of the protein c-Met. Patients have experienced better response rates and longer periods without cancer progression. Studies also indicate that this drug works well for patients with various genetic backgrounds. These findings suggest that telisotuzumab adizutecan could be a strong treatment option for those fighting colorectal cancer.12678

Who Is on the Research Team?

AI

ABBVIE INC.

Principal Investigator

AbbVie

Are You a Good Fit for This Trial?

This trial is for adults with colorectal cancer who have completed surgery and/or chemotherapy, but still show signs of cancer in their blood tests without visible disease on scans. Participants must be able to attend regular hospital or clinic visits.

Inclusion Criteria

My recent scans show no signs of cancer.
My cancer is confirmed to be adenocarcinoma of the colon or rectum.
I have received at least 3 months of specific chemotherapy for my rectal cancer.
See 4 more

Exclusion Criteria

I do not have a surgical tissue sample available.
I have had lung conditions treated with steroids or show signs of lung disease on a CT scan.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either telisotuzumab adizutecan monotherapy or standard of care for colorectal cancer

Up to 51 months
Regular visits at an approved institution (hospital or clinic)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

  • Telisotuzumab Adizutecan
Trial Overview The study compares the effects of a new drug, Telisotuzumab Adizutecan, given alone through IV infusion against the standard post-surgery care for colorectal cancer. It aims to see if there's a difference in how the disease progresses between these two approaches.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Telisotuzumab Adizutecan MonotherapyExperimental Treatment1 Intervention
Group II: Standard of Care (SOC)Active Control1 Intervention

Find a Clinic Near You

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 profile image

Robert A. Michael

AbbVie

Chief Executive Officer

Bachelor's degree in Finance from the University of Illinois

Citations

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 ...
Genomic alterations in circulating tumor DNA (ctDNA) and ...Telisotuzumab adizutecan has promising efficacy. RRs were seen in CRC pts with heterogeneous genomic profiles, including pts positive for actionable biomarkers ...
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, ...
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 ...
ESMO Research Highlights: NICHE-2 and FOxTROT ...Progression-free survival was 6.8 months versus 4.2 months, with similar rates of treatment-related adverse events at 67 versus 65 percent. A ...
Temab-A) monotherapy vs trifluridine/tipiracil plus ...Preliminary data from the ongoing first-in-human study of Temab-A (NCT05029882) indicate a tolerable safety profile and promising antitumor ...
Temab-A Displays Early Efficacy in Locally Advanced/ ...The median progression-free survival (PFS) was 5.4 months, with 73.8% of patients experiencing progression during the study period, and the ...
AbbVie Features New Data Across Difficult-to-Treat Solid ...Preliminary safety and efficacy results in 41 patients with pre-treated, advanced epidermal growth factor receptor (EGFR)-mutated non-squamous ...
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