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Monoclonal Antibodies

GEN1046 for Cancer

Phase 1 & 2

Waitlist Available

Research Sponsored by Genmab

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

For Both Dose Escalation and Expansion: Have Eastern Cooperative Oncology Group (ECOG) 0-1

For Both Dose Escalation and Expansion: Have acceptable coagulation status

Timeline

Screening 3 weeks

Treatment Varies

Follow Up throughout the study until disease progression/death/lost to follow-up/start of new anticancer therapy or withdrawal of consent, whichever occurs first (an expected average of 6 months)

Awards & highlights

Study Summary

This trial is testing a new drug, GEN1046, to see if it is safe to use alone or with other drugs to treat cancer.

Who is the study for?

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.Check my eligibility

What is being tested?

The trial tests acasunlimab alone and combined with other cancer drugs like docetaxel and pembrolizumab to see how safe they are for treating various solid tumors. It has two parts: dose escalation to find the right amount of drug to give safely and expansion where more people get the treatment at this dose to further check safety.See study design

What are the potential side effects?

While specific side effects aren't listed here, typical ones for cancer immunotherapies may include fatigue, skin reactions, inflammation in different body parts like lungs or intestines (which might cause coughing or diarrhea), hormonal imbalances and allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am fully active or can carry out light work.

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My blood clotting ability is within normal ranges.

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My blood test results are within normal ranges.

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I have a cancer that has spread and cannot be surgically removed, with no standard treatment options left.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ throughout the study until disease progression/death/lost to follow-up/start of new anticancer therapy or withdrawal of consent, whichever occurs first (an expected average of 6 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~throughout the study until disease progression/death/lost to follow-up/start of new anticancer therapy or withdrawal of consent, whichever occurs first (an expected average of 6 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and throughout the study until disease progression/death/lost to follow-up/start of new anticancer therapy or withdrawal of consent, whichever occurs first (an expected average of 6 months) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Adverse events

Dose limiting toxicity (DLT)

For expansion cohort 1 only: Objective Response Rate (ORR)

+1 more

Secondary outcome measures

Adverse events expansion, cohort 1 only

Anti-Drug Antibody (ADA) response

Disease Control Rate (DCR)

+7 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: ExpansionExperimental Treatment4 Interventions

Acasunlimab will be administered as monotherapy (or in combination with docetaxel or in combination with pembrolizumab or in combination with pembrolizumab and standard chemotherapy in separate expansion cohorts)

Group II: Dose escalationExperimental Treatment1 Intervention

Acasunlimab will be administered as monotherapy

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

GenmabLead Sponsor

56 Previous Clinical Trials

11,803 Total Patients Enrolled

BioNTech SEIndustry Sponsor

64 Previous Clinical Trials

108,752 Total Patients Enrolled

Study OfficialStudy DirectorGenmab

9 Previous Clinical Trials

2,200 Total Patients Enrolled

Media Library

GEN1046 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03917381 — Phase 1 & 2

Non-Small Cell Lung Cancer Research Study Groups: Dose escalation, Expansion

Non-Small Cell Lung Cancer Clinical Trial 2023: GEN1046 Highlights & Side Effects. Trial Name: NCT03917381 — Phase 1 & 2

GEN1046 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03917381 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many study volunteers are needed for this research project?

"The sponsor, BioNTech SE, needs 572 patients that fit the study's criteria in order to move forward. The trial will take place across several sites, such as Mayo Clinic in Phoenix, Arizona and Norton Healthcare Inc in Jacksonville, Florida."

Answered by AI

Are there a lot of hospitals in Canada participating in this research?

"In addition to 14 other sites, this experiment is currently enrolling patients that meet the eligibility criteria at Mayo Clinic in Phoenix, Arizona, Norton Healthcare Inc in Jacksonville, Florida, and Washington University School of Medicine in Louisville, Kentucky."

Answered by AI

What is the aim of this experiment?

"The primary outcome of this study will be the Objective Response Rate (ORR), which will be monitored throughout the treatment and for two months after the final subject has completed their treatment. Secondary outcomes include Anti-tumor activity, defined as ORR or Disease Control Rate (DCR), and Duration of Response (DoR). For expansion cohort 1 only: ORR, DoR, PFS per RECIST 1.1 assessed by investigator, and Overall survival (OS) will also be measured."

Answered by AI

Are there any other existing studies using GEN1046?

"There are a total of 337 research studies being conducted on GEN1046. Of these, 132 are in Phase 3 and still recruiting patients. Fuzhou, Fujian has the most concentration of research teams; however, there are 23,091 locations worldwide where GEN1046 is being studied."

Answered by AI

Are researchers currently looking for more volunteers for this trial?

"That is correct, the listed clinical trial on clinicaltrials.gov is currently looking for participants. 572 patients are needed to be recruited from 14 different sites. The study was first posted on May 14th, 2019 and was last updated on January 14th, 2022."

Answered by AI

What are the most frequent reasons that doctors prescribe GEN1046?

"GEN1046 is most commonly used to help fight cancerous growths. However, it can also be given to patients with other conditions like advance directives, sarcoma, and malignant esophageal neoplasms."

Answered by AI

Recent research and studies

Cancer DiscoveryJournal

Preclinical Characterization and Phase I Trial Results of a Bispecific Antibody Targeting PD-L1 and 4-1BB (GEN1046) in Patients with Advanced Refractory Solid Tumors

Muik, Alexander, Elena Garralda, Isil Altintas, Friederike Gieseke, Ravit Geva, Eytan Ben-Ami, Corinne Maurice-Dror, et al.. 2022. “Preclinical Characterization and Phase I Trial Results of a Bispecific Antibody Targeting PD-L1 and 4-1BB (GEN1046) in Patients with Advanced Refractory Solid Tumors”. Cancer Discovery. American Association for Cancer Research (AACR). doi:10.1158/2159-8290.cd-21-1345.

clinicaltrials.govStudy

GEN1046 Safety Trial in Patients With Malignant Solid Tumors

2019. "GEN1046 Safety Trial in Patients With Malignant Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03917381.

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