Study Details

Open

A Study to Evaluate the Safety and Efficacy of Multiple Treatment Combinations with Telisotuzumab Adizutecan in Adult Participants With Metastatic Colorectal Cancer

The purpose of this study is to explore the safety and efficacy of a study drug called Telisotuzumab adizutecan (ABBV-400) in combination with existing therapies in Metastatic Colorectal Cancer (mCRC) patients.

Age & Gender

18 years ~ 99 years
Male, Female, Gender Inclusive

Visit Availability

Standard business hours (M-F, 8-5)

Location

North Carolina (Statewide)

What will be asked of you

You will meet with the study team to see if you are eligible to take part in the study. This will include an exam, labs, and imaging. If you are eligible, you will be receive the study drug along with chemotherapy. You will also have exams, labs, imaging, and questionnaires during this time. After you complete treatment, you will be asked to return to clinic to meet with the study team to see how you are doing. You may also be contacted over the phone.

Incentives

In-person visits:
At least 8 visits, depends on how long you continue treatment

Phone or online visits:
Survival follow up may be completed by phone every 12 weeks

Total length of participation:
Participation will vary depending on how long you take the study drug

Looking for Specific Volunteers

Able to participate:

You have histologically or cytologically confirmed Metastatic Colon Cancer
You have archived tissue available, or are willing to have a tumor biopsy
You have lab values as required per protocol
You have measurable disease
You have not received any anti-cancer therapy within 28 days of treatment.

Not eligible if:

You have had prior systemic therapy for your Metastatic Colorectal Cancer
You have a significant lung illness
You have an active systemic or uncontrolled local bacterial, viral, or fungal infection requiring treatment
You have had a major surgery within 28 days prior to starting treatment
You have a history of another malignancy within 5 years prior to screening (with some exceptions)

Contact the Team

Visit Location

Contact & Visit Location

Primary Contact

Lineberger Clinical Research
cancerclinicaltrials@med.unc.edu

Primary Visit Location

Lineberger Comprehensive Cancer Center
NC Cancer Hospital (Basnight)
UNC Hospitals / UNC Medical Center
101 Manning Dr, Chapel Hill, NC 27514, USA

Secondary Visit Location

UNC Hospitals Hillsborough Campus
460 Waterstone Dr, Hillsborough, NC 27278, USA

Additional Study Information

Principal Investigator

Hanna Sanoff
LCCC - Clinical Trials

Study Type

Clinical or Medical
Interventional

Study Topics

Cancer (Colorectal)

IRB Number

24-3178

ClinicalTrials.gov

NCT06820463