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GEN1046 Safety Trial in Patients With Malignant Solid Tumor

This is an early phase clinical study for people with advanced stage cancer of one of the following types: non-small cell lung cancer, urothelial cancer, endometrial cancer, triple-negative breast cancer, squamous cell carcinoma of the head and neck or cervical cancer. The investigational drug, GEN1046 (DuoBody®-PD-L1x4-1BB), has been given only to a few humans so far and is not approved for sale. This study will test how well the investigational drug works against these cancers and what side effects may occur with GEN1046.

Age & Gender

18 years ~ 99 years
Male, Female, Gender Inclusive

Visit Availability

Standard business hours (M-F, 8-5)
Extended hours (M-F, early morning or evening)

Location

North Carolina (Statewide)

What will be asked of you

At each visit, you will meet with a member of the study team. The study also involves 15 blood draws, up to 4 ECGs, uranalysis, and willingness to take the study medication regularly.

Incentives

In-person visits:
16

Total length of participation:
About 2 months

Looking for Specific Volunteers

Able to participate:

Are at least 18 years old on the day of signing the informed consent
Have a malignant solid tumor
Have measurable disease based on RECIST 1.1, as assessed by the local Principal Investigator
Have adequate organ and bone function.
Have Adequate renal function.

Not eligible if:

Are pregnant
Had an uncontrolled illness
Had radiotherapy within 14 days prior to first GEN1046 administration
Have received any investigational agent (including investigational vaccines) or used an invasive investigational medical device within 28 days before the planned first dose
Have received a live vaccine within 3 weeks before the first dose of treatment

Contact the Team

Visit Location

Contact & Visit Location

Primary Contact

Primary Visit Location

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

Additional Study Information

Principal Investigator

Jared Weiss
LCCC - Clinical Trials

Study Type

Clinical or Medical
Interventional

Study Topics

Cancer (Bladder, Breast, Cervical, Head and Neck, Lung, Uterine (endometrial))

IRB Number

20-1681

ClinicalTrials.gov

NCT03917381

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Questions?

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