GEN1079 for Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new antibody treatment, GEN1079, to determine its safety and effectiveness for individuals with certain solid cancers. Researchers aim to identify the safest and most effective dose by trying different amounts. The trial welcomes participants with solid cancers that are inoperable or have metastasized. Participants must provide tumor samples and visit the trial site for various tests and check-ups. All participants receive the actual treatment, not a placebo. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.
Do I have to stop taking my current medications for the GEN1079 trial?
The trial information does not specify if you need to stop taking your current medications. However, you cannot have had any plasma-based therapy within 7 days before starting the trial treatment.
Is there any evidence suggesting that GEN1079 is likely to be safe for humans?
Research has shown that GEN1079 was safe in early trials, with patients tolerating it well. Some early signs suggest the treatment may be effective against cancer. However, as this is the first time it is being tested in humans, risks remain, and not all safety details are fully understood. Researchers will closely monitor participants for any side effects to ensure their safety.12345
Why do researchers think this study treatment might be promising?
Researchers are excited about GEN1079 because it offers a new approach to tackling cancer. Unlike traditional treatments like chemotherapy and radiation, which can damage healthy cells along with cancerous ones, GEN1079 is designed to target cancer cells more precisely. This precision could potentially result in fewer side effects and improved effectiveness. Additionally, by focusing on a novel mechanism, GEN1079 might work for patients who haven't responded well to existing therapies, offering new hope for those battling this challenging disease.
What evidence suggests that GEN1079 might be an effective treatment for cancer?
Research has shown that GEN1079 is a new type of treatment called an antibody, designed to target cancer cells. Antibodies are proteins that attach to harmful cells, such as cancer cells, to help the body combat them. Early studies suggest that treatments like GEN1079 hold promise for certain types of cancer. In this trial, participants will receive GEN1079 through various dosing strategies, including dose escalation, dose refinement, and expansion phases, to determine the most effective dose. Although the effectiveness of GEN1079 is still under study, early signs indicate its potential in cancer treatment.12367
Who Is on the Research Team?
Study Official
Principal Investigator
Genmab
Are You a Good Fit for This Trial?
This trial is for adults with certain advanced solid tumors (cancers that have spread or can't be removed by surgery) who have already tried other treatments. Participants need to have measurable cancer, good lab results, and must provide a tumor sample.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive escalating doses of GEN1079 to determine safety and optimal dosing
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- GEN1079
Trial Overview
The study tests different doses of GEN1079, an experimental antibody drug, to find the safest and most effective dose in people with advanced solid cancers. All participants receive GEN1079; there is no placebo group.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Cohorts of participants will receive up to 2 DLs of GEN1079 based on data from Dose Escalation/Dose Refinement.
Cohorts of participants will receive up to 3 DLs of based on data from the Dose Escalation.
Cohorts of participants will receive escalating doses of GEN1079 in up to 5 DLs.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Genmab
Lead Sponsor
Dr. Jan van de Winkel
Genmab
Chief Executive Officer since 2010
PhD in Immunology, University of Utrecht
Dr. Judith Klimovsky
Genmab
Chief Medical Officer since 2019
MD, University of Copenhagen
Citations
Study Details | NCT07387068 | Trial to Evaluate the Safety ...
The purpose of this trial is to learn about the safety and effectiveness of the antibody GEN1079 in participants with certain types of cancer.
Trial to Evaluate the Safety and Preliminary Efficacy of ...
The purpose of this trial is to learn about the safety and effectiveness of the antibody GEN1079 in participants with certain types of cancer. The trial has ...
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The treatment under review is GEN1079, an experimental antibody drug given as a concentrated solution. It is designed to target cancer cells in ...
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