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Monoclonal Antibodies

GEN1053 for Solid Tumors

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

Be ≥18 years of age

Meet specific organ and bone marrow function criteria as follows: Bone marrow/hematological function: ANC ≥1.5×10^9/L, Hemoglobin ≥9.0 g/dL, Platelet count ≥150×10^9/L; Liver function: Total bilirubin ≤ upper limit of normal (ULN), Alanine aminotransferase ≤1.5×ULN, Aspartate aminotransferase ≤1.5×ULN, Albumin ≥30 g/L; Coagulation status: PT/INR ≤1.5, aPTT ≤1.5×ULN, Renal function: Glomerular filtration rate ≥45 mL/min/1.73 m² according to the abbreviated Modification of Diet in Renal Disease equation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up collected throughout the trial until the end of the safety follow-up period (60 days after last dose)

Awards & highlights

Study Summary

This trial is testing a new drug, GEN1053, to see if it is safe and effective in treating cancer. The drug is an antibody that is designed to (re)activate and increase immunity to tumors. This is the first study of GEN1053 in humans, so the main purpose is to evaluate safety. The study will also determine the recommended GEN1053 dose to be tested in a larger group of participants and assess preliminary clinical activity of GEN1053. GEN1053 will be studied in a broad group of cancer patients, having different kinds of solid tumors. All participants will get GEN1053. The study consists of two parts:

Who is the study for?

This trial is for adults with various advanced solid tumors that have spread or can't be removed by surgery. Participants must have certain levels of blood, liver, and kidney function and no serious heart conditions, lung disease, infections needing IV treatment recently, uncontrolled high blood pressure, or a history of severe immune-related side effects from cancer immunotherapy.Check my eligibility

What is being tested?

The study tests GEN1053 as a solo therapy on patients with malignant solid tumors to find the safest dose and see how well it works. It has two parts: first 'escalation' to increase doses safely; then 'expansion' using the best dose found in part one.See study design

What are the potential side effects?

Since this is the first test of GEN1053 in humans, all potential side effects are not known yet. However, similar drugs often cause immune system reactions affecting different organs and may lead to inflammation or allergic responses.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 years old or older.

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My blood, liver, kidney, and clotting functions are within normal ranges.

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I am fully active and can carry on all pre-disease activities without restriction.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ throughout the trial until the end of the safety follow-up period (60 days after last dose)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~throughout the trial until the end of the safety follow-up period (60 days after last dose)

This trial's timeline: 3 weeks for screening, Varies for treatment, and throughout the trial until the end of the safety follow-up period (60 days after last dose) 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 (AEs) by incidence and severity

Escalation: Dose Limiting Toxicities (DLTs)

Number of participants with clinically significant shifts from baseline in clinical laboratory parameters

Secondary outcome measures

Amount of drug in the body (volume of distribution)

Anti-drug antibody response (ADA)

Area-under-the-concentration-time curve (AUC0-C last) and from time 0 to last quantifiable sample (AUC0-C infinity)

+8 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: GEN1053 MonotherapyExperimental Treatment1 Intervention

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

BioNTech SEIndustry Sponsor

65 Previous Clinical Trials

107,785 Total Patients Enrolled

GenmabLead Sponsor

57 Previous Clinical Trials

12,319 Total Patients Enrolled

Media Library

GEN1053 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05435339 — Phase 1 & 2

Solid Tumors Research Study Groups: GEN1053 Monotherapy

Solid Tumors Clinical Trial 2023: GEN1053 Highlights & Side Effects. Trial Name: NCT05435339 — Phase 1 & 2

GEN1053 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05435339 — Phase 1 & 2

Frequently Asked Questions

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

What are the principal aims of this research endeavor?

"The primary outcome to be measured over 21 days of each cohort is the incidence and severity Adverse Events (AEs). Secondary objectives include determining the peak drug concentration time, pre-dose trough concentration, and volume of distribution."

Answered by AI

Is this research venture presently accessible to participants?

"Per the data on clinicaltrials.gov, this medical experiment is actively in search of participants and was first made available to the public on October 4th 2022 with its most recent update coming November 24th 2022."

Answered by AI

How many individuals have been selected to participate in the trial thus far?

"Confirmed. Per information hosted on clinicaltrials.gov, this medical study was posted October 4th 2022 and recently updated November 24th 2022 - actively seeking patient recruitment with 103 volunteers required from 1 site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Evaluate Safety, Tolerability, and Preliminary Effect of the GEN1053 Antibody on Malignant Solid Tumors as Monotherapy

2022. "A Study to Evaluate Safety, Tolerability, and Preliminary Effect of the GEN1053 Antibody on Malignant Solid Tumors as Monotherapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05435339.