125 Participants Needed

Telisotuzumab Adizutecan for Cancer

Recruiting at 19 trial locations
AC
Overseen ByABBVIE CALL CENTER
Age: Any Age
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 tests a new drug, telisotuzumab adizutecan, to evaluate its effects on certain types of cancer. It targets individuals with advanced solid tumors that exhibit MET amplification, a change that can promote cancer growth. Participants will receive the drug via IV and undergo regular check-ups to monitor its effects. This trial suits those who have tried other treatments without success and have tumors with MET amplification. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial information does not specify if 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 telisotuzumab adizutecan is likely to be safe for humans?

Research shows that telisotuzumab adizutecan is generally safe. In previous studies, patients with hard-to-treat cancers, such as non-small cell lung cancer, tolerated the drug well. About 29 out of 100 patients experienced tumor shrinkage, an objective response rate of 28.6%.

A "manageable safety profile" means that while some side effects can occur, they are usually mild and manageable with regular medical care. For instance, in studies involving pancreatic cancer, side effects were similar to those seen in other cancer types. This suggests that although the drug is still under investigation, no unexpected safety issues have emerged.

Overall, researchers are carefully monitoring telisotuzumab adizutecan to ensure it remains safe for clinical trial participants.12345

Why do researchers think this study treatment might be promising?

Telisotuzumab Adizutecan is unique because it specifically targets a protein called c-Met, which is often overexpressed in certain cancers. Unlike standard treatments that might attack cancer more generally, this drug acts directly on cancer cells with high c-Met levels, potentially increasing effectiveness and reducing harm to healthy cells. Researchers are excited about Telisotuzumab Adizutecan because its precise action could lead to better outcomes for patients with fewer side effects compared to conventional chemotherapy.

What evidence suggests that telisotuzumab adizutecan might be an effective treatment for cancer?

Research shows that telisotuzumab adizutecan, the investigational treatment in this trial, may effectively treat solid tumors with MET amplification. One study found that patients whose tumor DNA was completely cleared experienced longer periods without cancer progression and lived longer overall. Another study showed the drug worked early, with patients experiencing an average of 5.4 months before cancer progression. It appears especially promising for cancers with high MET levels, such as colorectal cancer, where it improved response rates. While some patients experienced side effects, early results suggest it might help control tumor growth in certain cases.35678

Who Is on the Research Team?

AI

ABBVIE INC.

Principal Investigator

AbbVie

Are You a Good Fit for This Trial?

This trial is for people aged 12+ with advanced or metastatic solid tumors that have MET amplification. They should have measurable disease, be in good physical condition (ECOG 0-1), and must have tried standard treatments without success. Those with stable brain metastasis can join.

Inclusion Criteria

My cancer has MET amplification confirmed by NGS testing.
I am fully active or can carry out light work.
My cancer can be measured using specific medical criteria.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive intravenous telisotuzumab adizutecan for the treatment of solid tumors with MET amplification

61.5 months
Regular visits at approved institutions

Follow-up

Participants are monitored for safety and effectiveness after treatment

36 months

What Are the Treatments Tested in This Trial?

Interventions

  • Telisotuzumab Adizutecan

Trial Overview

The study tests Telisotuzumab Adizutecan, an experimental drug for cancers with MET amplification. All participants will receive the drug through IV over a period of about five years at one of up to 55 global sites.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Telisotuzumab AdizutecanExperimental Treatment1 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

AbbVie to Present New Data at ESMO 2025 Reinforcing ...

Patients with 100% ctDNA clearance had significantly higher PFS and overall survival (OS) vs. patients without ctDNA clearance.

Telisotuzumab adizutecan (ABBV-400; Temab-A), a c-Met ...

TEAEs leading to discontinuation occurred in 20% of pts. Four deaths occurred; 1 (pneumonitis) was considered related to study drug. All pts ...

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 ...

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 ...

A c-Met directed ADC shows preliminary activity in ...

Efficacy and safety of telisotuzumab adizutecan was investigated in patients with EGFR wild type non-squamous disease.

NCT06614192 | A Study Assessing Adverse Events and ...

The purpose of this study is to assess adverse events disease activity when comparing intravenously (IV) infused telisotuzumab adizutecan to trifluridine and ...

Dr Strickler on the Safety and Efficacy of Telisotuzumab ...

Investigators observed a 28.6% (95% CI, 15.7%-44.6%) objective response rate and a median progression-free survival of 4.0 months (95% CI, 2.76- ...

AbbVie Features New Data Across Difficult-to-Treat Solid ...

"Temab-A appears to have a manageable safety profile and continues to show promising clinical activity in advanced NSCLC, which is associated ...