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

NCT05586321 | Completed Phase 1

• 3 other identifiers: GCT1056-012022-001003-402024-514357-29-00
• Study Type: interventional
• Target: 26
• Locations: 3 countries
• Sites: 7

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.

Conditions

Solid Tumor, Adult

Keywords

Cancer; Advanced cancer; Phase I; Metastatic cancer

Outcome Measures

Primary Outcomes (3)

• Dose Limiting Toxicity (DLT)

  To define the maximum tolerated dose (MTD) and/or recommended phase 2 dose(s) (RP2D) of GEN1056

  DLTs are evaluated during the first 21 days after a patient's first dose

• Incidence and severity of adverse events (AEs)

  Throughout the trial until the end of the safety follow-up period (90 days after last dose)

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

  Clinical laboratory parameters assessed: Hematology, biochemistry, coagulation, TSH, T3 and T4, urinalysis

  Throughout the trial until the end of the safety follow-up period (90 days after last dose)

Secondary Outcomes (12)

• Objective response rate (ORR)

  From first infusion of trial drug to the last evaluable imaging assessment (an estimated average of 7 months)

• Duration of response (DOR)

  From initial onset of response to first progression event (defined as radiographic progression or death; an estimated average of 7 months)

• Progression-free survival (PFS)

  From first infusion of trial drug to first progression event (defined as radiographic progression or death; an estimated average of 7 months)

• Overall survival (OS)

  From first infusion of trial drug to death due to any cause, or to last contact date in case of no observed death (assessed up to 2 years after the last participant's first dose in the trial)

• Rate at which the drug is removed from the body (clearance)

  Throughout the trial until the end of the safety follow-up period (90 days after last dose)

Study Arms (1)

GEN1056 Monotherapy

EXPERIMENTAL

Biological: GEN1056

Interventions

GEN1056 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.

GEN1056 Monotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Genmab: lead
• BioNTech SE: collaborator

Study Sites (7)

ARENSIA Exploratory Medicine LLC

Tbilisi, Georgia

Location

ARENSIA Exploratory Medicine Phase I Unit

Chisinau, Moldova

Location

Hospital Universitari Vall d'Hebron

Barcelona, Spain

Location

Centro Integral Oncologico Clara Campal

Madrid, Spain

Location

Hospital Universitario Fundacion Jimenez Diaz

Madrid, Spain

Location

MD Anderson Cancer Centre

Madrid, Spain

Location

Clinica Universidad de Navarra

Pamplona, Spain

Location

MeSH Terms

Conditions

Neoplasms; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2022
• First Posted: October 19, 2022
• Study Start: October 24, 2022
• Primary Completion: October 23, 2025
• Study Completion: October 23, 2025
• Last Updated: November 24, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

GE (1); ES (5); MO (1)