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GEN1046 Safety Trial in Patients With Malignant Solid Tumors


Active: No
Cancer Type: Cervical Cancer
Lung Cancer
NCT ID: NCT03917381
Trial Phases: Phase I
Phase II
Protocol IDs: GCT1046-01 (primary)
NCI-2020-03735
Eligibility: 18 Years and older, Male and Female Study Type: Treatment
Study Sponsor: Genmab
NCI Full Details: http://clinicaltrials.gov/show/NCT03917381

Summary

The goal of this trial is to learn about the antibody acasunlimab (an antibody also known
as GEN1046) when it is used alone and when it is used together with standard of care
treatment (docetaxel) or another antibody cancer drug, pembrolizumab (with or without
chemotherapy), for treatment of patients with certain types of cancer. All subjects will
receive active drug; no one will receive placebo.

This trial has 2 parts. The purpose of the first part is to find out if acasunlimab is
safe and to find out the best doses of acasunlimab to use. The purpose of the second part
is to give acasunlimab to more subjects to see how well the doses of acasunlimab selected
in the first part work against cancer when given alone and how well they work when given
with pembrolizumab (with or without other chemotherapy) or docetaxel.

Trial details include:

- The average trial duration for an individual subject will be about 74 weeks.

- The average treatment duration for an individual subject will be about 21 weeks.

- The visit frequency will be weekly at first and lessening over time until visits are
only once every 3 weeks.

Objectives

The trial is an open-label, multi-center safety trial of acasunlimab (GEN1046). The trial
consists of two parts, a dose escalation part (phase 1, first-in-human [FIH] and an
expansion part [phase 2a]). The expansion part of the trial will be initiated once the
Recommended Phase 2 Dose (RP2D) has been determined.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.