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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
Must not have
Has uncontrolled intercurrent illness, including but not limited to: Ongoing or active infection requiring IV treatment with anti-infective therapy administered less than 2 weeks prior to first dose, Symptomatic congestive heart failure (Grade III or IV as classified by the New York Heart Association), unstable angina pectoris or cardiac arrhythmia, Uncontrolled hypertension defined as systolic blood pressure ≥160 mm Hg and/or diastolic blood pressure ≥100 mm Hg, despite optimal medical management, Prolonged QTc interval at baseline of ≥470 milliseconds using Fridericia's QT correction formula, Ongoing or recent (within 1 year) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk for irAEs, History of grade 3 or higher irAEs that led to treatment discontinuation of a CPI, History of chronic liver disease or evidence of hepatic cirrhosis, Evidence of interstitial lung disease, Ongoing pneumonitis or history of non-infectious pneumonitis that has required steroids, Known platelet function defects, Prior therapy: Radiotherapy within 14 days prior to first GEN1053 administration. Palliative radiotherapy will be allowed, Treatment with an anti-cancer agent (within 28 days or after at least 5 half-lives of the drug, whichever is shorter), prior to GEN1053 administration, Subject with a condition requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of first treatment. Inhaled or topical steroids, and adrenal or pituitary replacement steroid > 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up throughout the trial until the end of the safety follow-up period (60 days after last dose)
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new drug called GEN1053, which aims to help the immune system fight cancer better. It is for patients with advanced or metastatic solid tumors who have no other effective treatments. The study will check if GEN1053 is safe and find the best dose to use in future studies.

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.
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.
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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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 study objectives
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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: GEN1053 MonotherapyExperimental Treatment1 Intervention

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for solid tumors include immunotherapies such as monoclonal antibodies, which are designed to enhance the body's immune response against cancer cells. These antibodies can target specific proteins on the surface of cancer cells, marking them for destruction by the immune system. For example, GEN1053 is an antibody that aims to reactivate and increase antitumor immunity, potentially leading to better control of tumor growth. This approach is significant for solid tumor patients as it offers a targeted treatment option that can work in conjunction with the body's natural defenses, potentially improving outcomes and reducing side effects compared to traditional therapies like chemotherapy.
Current challenges and opportunities in treating adult patients with Philadelphia-negative acute lymphoblastic leukaemia.

Find a Location

Who is running the clinical trial?

BioNTech SEIndustry Sponsor
71 Previous Clinical Trials
111,088 Total Patients Enrolled
GenmabLead Sponsor
69 Previous Clinical Trials
14,871 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
~10 spots leftby Oct 2025