Solid Tumor, AdultPhase 1NCT05586321
Study of Safety and Antitumor Activity of GEN1056 in Participants With Advanced Solid Tumors
A Phase 1 study testing GEN1056 in people with Solid Tumor, Adult, run by Genmab at 7 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor, Adult
- What is being tested?
- GEN1056
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 7 sitesin 3 countries
- Study dates
- 24 Oct 2022to 23 Oct 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 12Show fewer
- 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.
- NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
7 sites in 3 countries.
7 sites in 3 countries
Spain5 sites
Hospital Universitari Vall d'Hebron
Barcelona
Centro Integral Oncologico Clara Campal
Madrid
Hospital Universitario Fundacion Jimenez Diaz
Madrid
MD Anderson Cancer Centre
Madrid
Clinica Universidad de Navarra
Pamplona
About this study
Official title: A First-in-Human, Open-label, Dose-finding Trial to Evaluate the Safety and Antitumor Activity of GEN1056 in Subjects With Advanced Solid Tumors
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.
Read the 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
- Being tested
- GEN1056
- Keywords
- Cancer, Advanced cancer, Phase I, Metastatic cancer
- Medical subject headings
- Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GEN1056Biological
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.
| Study group | Role | What they receive |
|---|---|---|
| GEN1056 Monotherapy | Experimental | Not described Receives: Biological: GEN1056 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Limiting Toxicity (DLT)
To define the maximum tolerated dose (MTD) and/or recommended phase 2 dose(s) (RP2D) of GEN1056
Measured: DLTs are evaluated during the first 21 days after a patient's first dose
Incidence and severity of adverse events (AEs)
Measured: 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
Measured: Throughout the trial until the end of the safety follow-up period (90 days after last dose)
Secondary outcomes (12)
Objective response rate (ORR)
Anti-tumor activity of GEN1056 as monotherapy according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 for responders (with confirmation)
Measured: From first infusion of trial drug to the last evaluable imaging assessment (an estimated average of 7 months)
Duration of response (DOR)
Anti-tumor activity of GEN1056 as monotherapy according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 for responders (with confirmation)
Measured: 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)
Anti-tumor activity of GEN1056 as monotherapy according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Measured: 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)
Defined as time of death, due to any cause
Measured: 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)
Measured: Throughout the trial until the end of the safety follow-up period (90 days after last dose)
Amount of drug in the body (volume of distribution)
Measured: Throughout the trial until the end of the safety follow-up period (90 days after last dose)
Area under the concentration time curve (AUC) from time zero to last quantifiable sample AUClast
Measured: Throughout the trial until the end of the safety follow-up period (90 days after last dose)
Maximum (peak) observed serum drug concentration (Cmax)
Measured: Throughout the trial until the end of the safety follow-up period (90 days after last dose)
Time to reach maximum (peak) serum drug concentration (Tmax) after dosing
Measured: Throughout the trial until the end of the safety follow-up period (90 days after last dose)
Time after dosing at which the lowest drug concentration is observed before the next dose is administered, predose trough concentration (Ctrough)
Measured: Throughout the trial until the end of the safety follow-up period (90 days after last dose)
Elimination half-life (T1/2) of the drug
Measured: Throughout the trial until the end of the safety follow-up period (90 days after last dose)
Incidence of anti-drug antibodies (anti GEN1056 antibodies)
Characterize the immunogenicity of GEN1056
Measured: Throughout the trial until the end of the safety follow-up period (90 days after last dose)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2022
- Study start24 Oct 2022
- Primary completion23 Oct 2025
- Study completion23 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Tumor, AdultStudies of the same condition, open and under way.
- More trials run by GenmabThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genmab
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- BioNTech SE
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05586321
- Sponsor's protocol ID
- GCT1056-01
- Other IDs
- 2022-001003-40, 2024-514357-29-00
- Status last verified
- Nov 2025
- First submitted
- 11 Oct 2022
- Last updated
- 24 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First-in-Human, Open-label, Dose-finding Trial to Evaluate the Safety and Antitumor Activity of GEN1056 in Subjects With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT05586321
- Acronym / sponsor ID
- GCT1056-01
- Conditions
- Solid Tumor, Adult
- Keywords
- Cancer, Advanced cancer, Phase I, Metastatic cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- GenmabIndustry (pharma, biotech, devices)
- Collaborators
- BioNTech SE
- Study start
- 24 Oct 2022 (actual)
- Primary completion
- 23 Oct 2025 (actual)
- Study completion
- 23 Oct 2025 (actual)
- First posted
- 19 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GEN1056 Monotherapy | Experimental | Biological: GEN1056 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (12 listed)
- 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:
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GEN1056GEN1056 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. | Biological | GEN1056 Monotherapy |
Primary outcome
Dose Limiting Toxicity (DLT)
Time frame: DLTs are evaluated during the first 21 days after a patient's first dose
To define the maximum tolerated dose (MTD) and/or recommended phase 2 dose(s) (RP2D) of GEN1056
Incidence and severity of adverse events (AEs)
Time frame: 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
Time frame: Throughout the trial until the end of the safety follow-up period (90 days after last dose)
Clinical laboratory parameters assessed: Hematology, biochemistry, coagulation, TSH, T3 and T4, urinalysis
12 secondary outcomes
Objective response rate (ORR)
Time frame: From first infusion of trial drug to the last evaluable imaging assessment (an estimated average of 7 months)
Duration of response (DOR)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: Throughout the trial until the end of the safety follow-up period (90 days after last dose)
Amount of drug in the body (volume of distribution)
Time frame: Throughout the trial until the end of the safety follow-up period (90 days after last dose)
Area under the concentration time curve (AUC) from time zero to last quantifiable sample AUClast
Time frame: Throughout the trial until the end of the safety follow-up period (90 days after last dose)
Maximum (peak) observed serum drug concentration (Cmax)
Time frame: Throughout the trial until the end of the safety follow-up period (90 days after last dose)
Time to reach maximum (peak) serum drug concentration (Tmax) after dosing
Time frame: Throughout the trial until the end of the safety follow-up period (90 days after last dose)
Time after dosing at which the lowest drug concentration is observed before the next dose is administered, predose trough concentration (Ctrough)
Time frame: Throughout the trial until the end of the safety follow-up period (90 days after last dose)
Elimination half-life (T1/2) of the drug
Time frame: Throughout the trial until the end of the safety follow-up period (90 days after last dose)
Incidence of anti-drug antibodies (anti GEN1056 antibodies)
Time frame: Throughout the trial until the end of the safety follow-up period (90 days after last dose)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GEN1056 in people with Solid Tumor, Adult, run by Genmab at 7 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Spain, Georgia, Moldova. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose Limiting Toxicity (DLT) (time frame: DLTs are evaluated during the first 21 days after a patient's first dose). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2025.