What side effects are associated with this type of intervention?

Common side effects of immunotherapies for solid tumors, such as those similar to GEN1053, include immune-related adverse events (irAEs) like colitis, dermatitis, hepatitis, endocrinopathies (e.g., thyroiditis, adrenal insufficiency), and pneumonitis. These occur due to the immune system attacking normal tissues along with cancer cells. Management typically involves immunosuppressive treatments like corticosteroids.

What prior FDA approvals exist?

The FDA has approved several antibodies designed to reactivate and increase antitumor immunity for the treatment of solid tumors. Notable examples include pembrolizumab (Keytruda) and nivolumab (Opdivo), which are immune checkpoint inhibitors targeting PD-1, and ipilimumab (Yervoy), which targets CTLA-4. These drugs have been approved for various solid tumors, including melanoma, non-small cell lung cancer, and head and neck cancers. These treatments work by blocking inhibitory pathways that prevent the immune system from attacking cancer cells, thereby enhancing antitumor immunity.

What other types of research exist?

Promising novel alternatives to GEN1053 for solid tumor patients include: 1) Immune checkpoint inhibitors such as anti-PD-1 or anti-PD-L1 therapies (e.g., nivolumab, pembrolizumab) which have shown efficacy in various solid tumors. 2) Combination therapies involving immune checkpoint inhibitors and other agents, such as atezolizumab combined with chemotherapy (e.g., FOLFOXIRI plus bevacizumab). 3) Monoclonal antibodies like blinatumomab, which have been recognized for their potential in enhancing antitumor immunity.

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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 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

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

0 / 4Eligibility criteria met

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.

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