Study of Safety and Antitumor Activity of GEN1056 in Participants With Advanced Solid Tumors

NCT ID: NCT05586321

Last Updated: 2025-11-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-24
• Study Completion Date: 2025-10-23

Brief Summary

The main purpose of this first-in-human study of GEN1056, is to evaluate safety. In addition, the study will determine the recommended dose and frequency for subsequent clinical studies and will assess the preliminary anti-tumor activity of GEN1056. GEN1056 will be studied in patients with advanced or metastatic solid cancer, for whom standard of care (SOC) therapy is not an option. All participants will get GEN1056.

Detailed Description

The trial is a first-in-human open-label, dose-finding, multinational safety trial, in participants with advanced or metastatic solid (non central nervous system [CNS]) tumors that have exhausted SOC therapy or are not candidates for SOC therapy, evaluating the safety, tolerability, preliminary antitumor activity, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of GEN1056.

The trial will be conducted as follows:

• The Dose Escalation part (Part 1) will explore the safety of escalating doses of GEN1056
• The Dose schedule optimization part (Part 2) will explore further safety and tolerability in an alternate schedule of a dose based on data outcome available from Part 1.

Conditions

Solid Tumor, Adult

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

GEN1056 Monotherapy

Group Type: EXPERIMENTAL

GEN1056

Intervention Type: BIOLOGICAL

GEN1056 will be administered as an intravenous (IV) infusion. The dose levels will be determined by the starting dose and the escalation steps taken in the trial in Part 1. In Part 2, the dose and schedule will be decided based on data outcome from Part 1.

Interventions

GEN1056

GEN1056 will be administered as an intravenous (IV) infusion. The dose levels will be determined by the starting dose and the escalation steps taken in the trial in Part 1. In Part 2, the dose and schedule will be decided based on data outcome from Part 1.

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Subjects with histologically or cytologically confirmed non-CNS advanced or metastatic solid tumors which has progressed despite standard therapy, or subjects who are intolerant of standard therapy, or for which no standard therapy exists, and for whom, in the opinion of the investigator, experimental therapy with GEN1056 may be beneficial
• Have personally (or in countries where permitted, their legally acceptable representative) signed an Informed Consent Form (ICF)
• Are at least 18 years of age.
• Have measurable disease according to the RECIST v1.1 criteria.
• Have an ECOG PS of 0 to 1 at screening and on C1D1 pre-treatment.
• Have acceptable laboratory test results during the screening period.
• Must provide an archival (FFPE) tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated.
• A female subject with reproductive potential must agree to use adequate contraception during the trial, and for 4 months after receiving the last dose of trial drug GEN1056.

Exclusion Criteria

• Subject is considered a poor medical risk due to a serious, uncontrolled inter-current illness
• Prior therapy with a checkpoint inhibitor agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor.
• Prior exposure to any of the following prior therapies within the specified timeframes:

1. Systemic cytotoxic chemotherapy or antineoplastic biological therapy within 28 days or at least 5 elimination half-lives of the drug (whichever is shorter) of the first dose of trial treatment

2. Radiotherapy within 21 days of start of trial treatment. Note: palliative radiotherapy be allowed.

3. Prior treatment with live, attenuated vaccines within 28 days prior to initiation of GEN1056

• Known active CNS metastases and/or carcinomatous meningitis, or spinal cord compression.
• Positive for Human Immunodeficiency Virus (HIV), Hepatitis B (Hepatitis B Surface Antigen (HBsAg), HBV DNA), or Hepatitis C infection (Hepatitis C Virus Ribonucleic Acid (HCV RNA), HCV antibodies).
• An active, known, or suspected autoimmune disease, requiring systemic steroid.
• A condition requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of first treatment.
• History of non-infectious pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease requiring treatment with steroids.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

BioNTech SE

INDUSTRY

Sponsor Role: collaborator

Genmab

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

ARENSIA Exploratory Medicine LLC

Tbilisi, , Georgia

ARENSIA Exploratory Medicine Phase I Unit

Chisinau, , Moldova

Hospital Universitari Vall d'Hebron

Barcelona, , Spain

Centro Integral Oncologico Clara Campal

Madrid, , Spain

Hospital Universitario Fundacion Jimenez Diaz

Madrid, , Spain

MD Anderson Cancer Centre

Madrid, , Spain

Clinica Universidad de Navarra

Pamplona, , Spain

Countries

Georgia; Moldova; Spain

Other Identifiers

2022-001003-40

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

2024-514357-29-00

Identifier Type: OTHER

Identifier Source: secondary_id

GCT1056-01

Identifier Type: -

Identifier Source: org_study_id