GEN1046 for Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores the safety and effectiveness of a new antibody treatment called acasunlimab (GEN1046) for certain advanced or metastatic cancers. The trial tests acasunlimab alone and in combination with other cancer treatments like docetaxel and pembrolizumab. It targets individuals with cancers such as lung, cervical, or throat cancer that have not responded to other treatments. Participants must have a cancer diagnosis confirmed by a doctor and should not have other serious conditions, such as uncontrolled high blood pressure or active infections. The goal is to determine the best dose of acasunlimab and evaluate its effectiveness alone or with other treatments. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.
Will I have to stop taking my current medications?
The trial protocol does not specify if you must stop taking your current medications, but it does mention that you should not have had certain anti-cancer treatments within 28 days before starting the trial. It's best to discuss your current medications with the trial team to get specific guidance.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that acasunlimab (GEN1046) has a manageable safety profile based on earlier studies. For example, when combined with pembrolizumab, another cancer drug, most patients did not experience side effects severe enough to stop treatment.
In another study, patients with certain types of cancer who received acasunlimab had a 69% chance of surviving for at least 12 months, suggesting the treatment did not cause serious harm over a year.
Acasunlimab remains under investigation. As this trial is in the early stages (Phase 1 and Phase 2), researchers are primarily focused on identifying the safest doses. While the treatment appears safe so far, further testing is necessary to fully understand its safety in humans.12345Why are researchers excited about this trial's treatments?
Researchers are excited about GEN1046, also known as acasunlimab, because it offers a novel approach to treating cancer by targeting both PD-L1 and 4-1BB pathways. This dual targeting mechanism is designed to enhance the body's immune response against cancer cells, potentially offering a more effective treatment than standard therapies like pembrolizumab or chemotherapy alone. Additionally, GEN1046 can be used as a monotherapy or in combination with existing treatments, providing flexibility and potentially improving outcomes for patients who may not respond to current options. This innovative approach could lead to more personalized and effective cancer treatments.
What evidence suggests that this trial's treatments could be effective for cancer?
Research has shown that acasunlimab, when used alone, yields promising results. In one study, 69% of patients survived after 12 months, and 30% showed a positive response to the treatment. This indicates that many patients lived longer and responded well. Acasunlimab boosts the immune system to fight cancer by targeting specific proteins on cancer cells.
In this trial, acasunlimab will be administered as monotherapy in the Dose Escalation arm. In the Expansion arm, acasunlimab will be given either as monotherapy or combined with other treatments, such as pembrolizumab, docetaxel, or pembrolizumab plus standard chemotherapy, in separate expansion cohorts. When combined with pembrolizumab, acasunlimab has shown a safety profile that patients can handle well. This combination aims to further strengthen the immune response. These early findings suggest that acasunlimab, either alone or with other treatments, could be effective against certain types of cancer.13567Who 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 cancers (like lung, breast, bladder, or cervical cancer) that have relapsed or spread and can't be treated with standard therapies anymore. They should be in good physical condition (ECOG 0-1), have tumors that can be measured by scans, and their organs must function well. People who've had recent serious illnesses, infections needing IV drugs, severe side effects from immune treatments before, heart problems, uncontrolled blood pressure or autoimmune diseases cannot join.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Dose Escalation
Acasunlimab is administered as monotherapy to determine the Recommended Phase 2 Dose (RP2D)
Expansion
Acasunlimab is administered as monotherapy or in combination with docetaxel, pembrolizumab, or pembrolizumab + standard chemotherapy
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- GEN1046
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
BioNTech SE
Industry Sponsor
Prof. Dr. Ugur Sahin
BioNTech SE
Chief Executive Officer since 2008
MD from University of Cologne
Prof. Özlem Türeci
BioNTech SE
Chief Medical Officer since 2018
MD from Saarland University