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

Last updated: November 21, 2025
Sponsor: Genmab
Overall Status: Completed

Phase

1

Condition

Neoplasms

Neoplasm Metastasis

Treatment

GEN1056

Clinical Study ID

NCT05586321
GCT1056-01
2022-001003-40
2024-514357-29-00
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  • Subjects with histologically or cytologically confirmed non-CNS advanced ormetastatic solid tumors which has progressed despite standard therapy, or subjectswho are intolerant of standard therapy, or for which no standard therapy exists, andfor whom, in the opinion of the investigator, experimental therapy with GEN1056 maybe beneficial

  • Have personally (or in countries where permitted, their legally acceptablerepresentative) 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 orexcisional biopsy of a tumor lesion not previously irradiated.

  • A female subject with reproductive potential must agree to use adequatecontraception during the trial, and for 4 months after receiving the last dose oftrial drug GEN1056.

Exclusion

Key Exclusion Criteria:

  • Subject is considered a poor medical risk due to a serious, uncontrolledinter-current illness

  • Prior therapy with a checkpoint inhibitor agent or with an agent directed to anotherstimulatory or co-inhibitory T-cell receptor.

  • Prior exposure to any of the following prior therapies within the specifiedtimeframes:

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

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

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

  • Known active CNS metastases and/or carcinomatous meningitis, or spinal cordcompression.

  • Positive for Human Immunodeficiency Virus (HIV), Hepatitis B (Hepatitis B SurfaceAntigen (HBsAg), HBV DNA), or Hepatitis C infection (Hepatitis C Virus RibonucleicAcid (HCV RNA), HCV antibodies).

  • An active, known, or suspected autoimmune disease, requiring systemic steroid.

  • A condition requiring systemic treatment with either corticosteroids (>10 mg dailyprednisone equivalent) or other immunosuppressive medications within 14 days offirst treatment.

  • History of non-infectious pneumonitis/interstitial lung disease that requiredsteroids or has current pneumonitis/interstitial lung disease requiring treatmentwith steroids.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Design

Total Participants: 26
Treatment Group(s): 1
Primary Treatment: GEN1056
Phase: 1
Study Start date:
October 24, 2022
Estimated Completion Date:
October 23, 2025

Study 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.

Connect with a study center

  • ARENSIA Exploratory Medicine LLC

    Tbilisi,
    Georgia

    Site Not Available

  • ARENSIA Exploratory Medicine LLC

    Tbilisi 611717,
    Georgia

    Site Not Available

  • ARENSIA Exploratory Medicine Phase I Unit

    Chisinau 618426,
    Moldova

    Site Not Available

  • ARENSIA Exploratory Medicine Phase I Unit

    Chisinau,
    Moldova, Republic of

    Site Not Available

  • Hospital Universitari Vall d'Hebron

    Barcelona,
    Spain

    Site Not Available

  • Hospital Universitari Vall d'Hebron

    Barcelona 3128760,
    Spain

    Site Not Available

  • Centro Integral Oncologico Clara Campal

    Madrid,
    Spain

    Site Not Available

  • Hospital Universitario Fundacion Jimenez Diaz

    Madrid,
    Spain

    Site Not Available

  • MD Anderson Cancer Centre

    Madrid,
    Spain

    Site Not Available

  • Centro Integral Oncologico Clara Campal

    Madrid 3117735,
    Spain

    Site Not Available

  • Hospital Universitario Fundacion Jimenez Diaz

    Madrid 3117735,
    Spain

    Site Not Available

  • MD Anderson Cancer Centre

    Madrid 3117735,
    Spain

    Site Not Available

  • Clinica Universidad de Navarra

    Pamplona,
    Spain

    Site Not Available

  • Clinica Universidad de Navarra

    Pamplona 3114472,
    Spain

    Site Not Available

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