Solid Tumor, AdultPhase 1/2NCT05435339
A Study to Evaluate Safety, Tolerability, and Preliminary Effect of the GEN1053 Antibody on Malignant Solid Tumors as Monotherapy
A Phase 1/2 study testing GEN1053 in people with Solid Tumor, Adult, run by Genmab at 5 sites in 2 countries.
Trial summary
The drug that will be investigated in the study is GEN1053. GEN1053 is an antibody designed to (re)activate and increase antitumor immunity. Since this is the first study of GEN1053 in humans, the main purpose is to evaluate safety. 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?
- GEN1053
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 4 Oct 2022to 24 May 2024
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- For both the Dose Escalation and Expansion parts:
- Be ≥18 years of age.
- Have measurable disease according to RECIST 1.1
- Provide all pre-baseline scans since failure of last prior therapy (ie radiographic PD), if available
- Have Eastern Cooperative Oncology Group performance status ≤1.
- Have organ and bone marrow function as follows:
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- Bone marrow / hematological function:
- Absolute neutrophil count (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:
- Prothrombin time (PT)/International normalized ratio ≤1.5
- Activated partial thromboplastin time (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
- For Monotherapy Dose Escalation (phase 1) only:
- Subjects with histologically or cytologically confirmed non-CNS solid tumors that are metastatic or advanced.
- Subjects who have progressed on standard of care therapy or for whom there is no available standard therapy likely to provide clinical benefit, or who are not candidates for or refuse such available therapy, and for whom, in the opinion of the investigator, experimental therapy with GEN1053 may be beneficial.
- Fresh biopsies mandatory for all patients in Monotherapy Dose Escalation
- For the Expansion part Only:
- •Subjects with histologically or cytologically confirmed diagnosis of recurrent, unresectable or metastatic HNSCC, who have progressed on standard of care therapy or do not have any further available standard therapy or are not candidates for or refuse standard therapy (if subjects had access), and for whom experimental therapy with GEN1053 may be beneficial in the opinion of the investigator.
Who cannot join
- 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.
Show all 16Show fewer
- 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.
- NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
Spain3 sites
Hospital Universitari Vall d'Hebron
Barcelona
Centro Integral Oncologico Clara Campal
Madrid
Clinica Universidad de Navarra
Pamplona, Navarre
United States2 sites
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
Yale University
New Haven, Connecticut, 06510
About this study
Official title: First-in-Human, Open-label, Dose-Escalation Trial With an Expansion Cohort to Evaluate the Safety of GEN1053 as Monotherapy in Subjects With Malignant Solid Tumors
The drug that will be investigated in the study is GEN1053. GEN1053 is an antibody designed to (re)activate and increase antitumor immunity.
Since this is the first study of GEN1053 in humans, the main purpose is to evaluate safety. Besides safety, the study will determine the recommended GEN1053 dose to be tested in a larger group of participants and assess preliminary clinical activity of GEN1053.
GEN1053 will be studied in a broad group of cancer patients, having different kinds of solid tumors. All participants will get GEN1053. The study consists of two parts: Part 1 tests increasing doses of GEN1053 ("escalation"), followed by Part 2 which tests the recommended phase 2 dose GEN1053 dose from Part 1 ("expansion").
Read the detailed description
The trial is a First in Human open-label, multicenter, multinational safety trial in participants with non-central nervous system (non-CNS) metastatic or advanced malignant solid tumors for whom there is no available standard therapy likely to confer clinical benefit, evaluating the safety, tolerability, preliminary antitumor activity, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of GEN1053.
The trial will be conducted as follows:
- The Dose Escalation part (Part 1) will explore the safety of escalating doses of GEN1053 as monotherapy (phase 1)
- The Expansion part (Part 2) is planned to provide additional safety and initial antitumor activity information of the Recommended Phase 2 dose (RP2D) for GEN1053 monotherapy in selected tumor indications, as well as more detailed data related to the mode of action (MoA).
- Conditions
- Solid Tumor, Adult
- Being tested
- GEN1053
- Keywords
- Monoclonal antibody
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GEN1053Biological
GEN1053 will be administered as an intravenous (IV) infusion every 3rd week. The dose levels will be determined by the starting dose and the escalation steps taken in the trial.
| Study group | Role | What they receive |
|---|---|---|
| GEN1053 Monotherapy | Experimental | Not described Receives: Biological: GEN1053 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Dose Limiting Toxicities (DLTs)
The occurrence of any of the following toxicities, assessed as related to trial treatment, were considered DLTs: All Grade 5 events, Grade 4 anaphylaxis, infusion-related reactions and neutropenia for ≥7 days, Grade 3/4 febrile neutropenia, Grade 4 thrombocytopenia, Grade 3 thrombocytopenia with clinically significant bleeding, Grade 4 anemia, Grade 4 aspartate aminotransferase (AST), alanine aminotransferase (ALT), or bilirubin elevation/Grade 3 that did not recover to ≤Grade 1 within 14 days, AST or ALT elevations ≥Grade 2 with concomitant bilirubin >2.0×upper limit of normal with no signs of cholestasis, any Grade 4 immune-related adverse event (irAE), Grade 3 irAEs that did not improve to ≤Grade 1 within 7 days (with exceptions), Grade 4 cytokine release syndrome (CRS), Grade 3 CRS not resolved to ≤Grade 2 within 48 hrs following adequate intervention, any other ≥Grade 3 nonhematological adverse event (AE) during the first GEN1053 treatment cycle (with exceptions), cycle=3 weeks.
Measured: Day 1 up to Day 21
Number of Participants With At Least One Treatment-emergent Adverse Event (TEAE)
An adverse event (AE) was any untoward medical occurrence in a participant or clinical trial participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE was therefore any unfavorable and unintended sign (including an abnormal safety laboratory parameter finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. A TEAE was defined as an AE occurring or worsening after first dose. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.
Measured: Up to approximately 1.5 years
Secondary outcomes (12)
Clearance (CL) of GEN1053
Venous blood samples were collected for analyzing the pharmacokinetics (PK) of GEN1053.
Measured: Cycle 1 and Cycle 3 (cycles were 3 weeks)
Volume of Distribution (Vz) of GEN1053
Venous blood samples were collected for analyzing concentrations of GEN1053.
Measured: Cycle 1 and Cycle 3 (cycles were 3 weeks)
Maximum (Peak) Concentration (Cmax) of GEN1053
Venous blood samples were collected for analyzing concentrations of GEN1053.
Measured: Cycle 1 and Cycle 3 (cycles were 3 weeks)
Time to Maximum (Peak) Concentration (Tmax) of GEN1053
Venous blood samples were collected for analyzing concentrations of GEN1053.
Measured: Cycle 1 and Cycle 3 (cycles were 3 weeks)
Predose Trough Concentration (Ctrough) of GEN1053
Venous blood samples were collected for analyzing concentrations of GEN1053.
Measured: Cycle 1 and Cycle 3 (cycles were 3 weeks)
Elimination Half-life (t1/2) of GEN1053
Venous blood samples were collected for analyzing concentrations of GEN1053.
Measured: Cycle 1 and Cycle 3 (cycles were 3 weeks)
Area Under the Concentration-time Curve (AUC) From Time Zero to Last Quantifiable Measurement (AUClast) of GEN1053
Venous blood samples were collected for analyzing concentrations of GEN1053.
Measured: Cycle 1 and Cycle 3 (cycles were 3 weeks)
AUC From Time Zero Over the Dosing Interval (AUCtau) of GEN1053
Venous blood samples were collected for analyzing concentrations of GEN1053.
Measured: Cycle 1 and Cycle 3 (cycles were 3 weeks)
Number of Participants With Anti-drug Antibodies (ADAs) to GEN1053
Venous blood samples were drawn for analysis of ADAs in serum samples.
Measured: Cycle 1 Day 1 through end of safety follow up (60 days after last dose [cycles were 3 weeks]), up to approximately 1.5 years
Objective Response Rate (ORR)
ORR was defined as the number of participants with best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR) (ie, "responders"), as per local review and according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. CR was defined as all of the following: disappearance of all target and non-target tumor lesions, and reduction in short axis to <10 millimeters (mm) in all pathological target and non-target lymph nodes, and normalization of tumor marker level (if applicable). PR was defined as ≥30 percent (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Data are presented for the number of participants with ORR.
Measured: Up to approximately 1.5 years
Disease Control Rate (DCR)
DCR was defined as the number of participants with CR, PR, or stable disease (SD). CR was defined as all of the following: disappearance of all target and non-target tumor lesions, and reduction in short axis to <10 mm in all pathological target and non-target lymph nodes, and normalization of tumor marker level (if applicable). PR was defined as ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters (nadir) while on study. Data are presented for the number of participants with DCR.
Measured: Up to approximately 1.5 years
Duration of Response (DOR)
DOR was defined as the time from the first documentation of objective tumor response (CR or PR) to the date of first PD or death due to any cause in participants whose confirmed BOR was CR or PR.
Measured: Up to approximately 1.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2022
- Study start4 Oct 2022
- Primary completion24 May 2024
- Study completion24 May 2024
Why it stopped: Due to strategic evaluation of GEN1053 within the context of Genmab's portfolio
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Sequential assignment
- Masking
- None (open label)
- Enrolment
- 31 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
- NCT05435339
- Sponsor's protocol ID
- GCT1053-01
- Other IDs
- 2021-006692-42, 1005700, 2022-502419-12-00
- Status last verified
- Apr 2025
- First submitted
- 23 Jun 2022
- Last updated
- 22 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- First-in-Human, Open-label, Dose-Escalation Trial With an Expansion Cohort to Evaluate the Safety of GEN1053 as Monotherapy in Subjects With Malignant Solid Tumors
- ClinicalTrials.gov ID
- NCT05435339
- Acronym / sponsor ID
- GCT1053-01
- Conditions
- Solid Tumor, Adult
- Keywords
- Monoclonal antibody
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to strategic evaluation of GEN1053 within the context of Genmab's portfolio
- Enrolment
- 31 participants (actual)
- Lead sponsor
- GenmabIndustry (pharma, biotech, devices)
- Collaborators
- BioNTech SE
- Study start
- 4 Oct 2022 (actual)
- Primary completion
- 24 May 2024 (actual)
- Study completion
- 24 May 2024 (actual)
- First posted
- 28 Jun 2022 (actual)
- Results
- Posted 22 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The drug that will be investigated in the study is GEN1053. GEN1053 is an antibody designed to (re)activate and increase antitumor immunity.
Since this is the first study of GEN1053 in humans, the main purpose is to evaluate safety. Besides safety, the study will determine the recommended GEN1053 dose to be tested in a larger group of participants and assess preliminary clinical activity of GEN1053.
GEN1053 will be studied in a broad group of cancer patients, having different kinds of solid tumors. All participants will get GEN1053. The study consists of two parts: Part 1 tests increasing doses of GEN1053 ("escalation"), followed by Part 2 which tests the recommended phase 2 dose GEN1053 dose from Part 1 ("expansion").
Detailed description
The trial is a First in Human open-label, multicenter, multinational safety trial in participants with non-central nervous system (non-CNS) metastatic or advanced malignant solid tumors for whom there is no available standard therapy likely to confer clinical benefit, evaluating the safety, tolerability, preliminary antitumor activity, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of GEN1053.
The trial will be conducted as follows:
- The Dose Escalation part (Part 1) will explore the safety of escalating doses of GEN1053 as monotherapy (phase 1)
- The Expansion part (Part 2) is planned to provide additional safety and initial antitumor activity information of the Recommended Phase 2 dose (RP2D) for GEN1053 monotherapy in selected tumor indications, as well as more detailed data related to the mode of action (MoA).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Sequential assignment
| Arm | Type | Receives |
|---|---|---|
| GEN1053 Monotherapy | Experimental | Biological: GEN1053 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- Be ≥18 years of age.
- Have measurable disease according to RECIST 1.1
- Provide all pre-baseline scans since failure of last prior therapy (ie radiographic PD), if available
- Have Eastern Cooperative Oncology Group performance status ≤1.
- Have organ and bone marrow function as follows:
Key exclusion criteria (16 listed)
- Has uncontrolled intercurrent illness, including but not limited to:
- Prior therapy:
- NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
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 |
|---|---|---|
| GEN1053GEN1053 will be administered as an intravenous (IV) infusion every 3rd week. The dose levels will be determined by the starting dose and the escalation steps taken in the trial. | Biological | GEN1053 Monotherapy |
Primary outcome
Number of Participants With Dose Limiting Toxicities (DLTs)
Time frame: Day 1 up to Day 21
The occurrence of any of the following toxicities, assessed as related to trial treatment, were considered DLTs: All Grade 5 events, Grade 4 anaphylaxis, infusion-related reactions and neutropenia for ≥7 days, Grade 3/4 febrile neutropenia, Grade 4 thrombocytopenia, Grade 3 thrombocytopenia with clinically significant bleeding, Grade 4 anemia, Grade 4 aspartate aminotransferase (AST), alanine aminotransferase (ALT), or bilirubin elevation/Grade 3 that did not recover to ≤Grade 1 within 14 days, AST or ALT elevations ≥Grade 2 with concomitant bilirubin >2.0×upper limit of normal with no signs of cholestasis, any Grade 4 immune-related adverse event (irAE), Grade 3 irAEs that did not improve to ≤Grade 1 within 7 days (with exceptions), Grade 4 cytokine release syndrome (CRS), Grade 3 CRS not resolved to ≤Grade 2 within 48 hrs following adequate intervention, any other ≥Grade 3 nonhematological adverse event (AE) during the first GEN1053 treatment cycle (with exceptions), cycle=3 weeks.
Number of Participants With At Least One Treatment-emergent Adverse Event (TEAE)
Time frame: Up to approximately 1.5 years
An adverse event (AE) was any untoward medical occurrence in a participant or clinical trial participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE was therefore any unfavorable and unintended sign (including an abnormal safety laboratory parameter finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. A TEAE was defined as an AE occurring or worsening after first dose. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.
12 secondary outcomes
Clearance (CL) of GEN1053
Time frame: Cycle 1 and Cycle 3 (cycles were 3 weeks)
Volume of Distribution (Vz) of GEN1053
Time frame: Cycle 1 and Cycle 3 (cycles were 3 weeks)
Maximum (Peak) Concentration (Cmax) of GEN1053
Time frame: Cycle 1 and Cycle 3 (cycles were 3 weeks)
Time to Maximum (Peak) Concentration (Tmax) of GEN1053
Time frame: Cycle 1 and Cycle 3 (cycles were 3 weeks)
Predose Trough Concentration (Ctrough) of GEN1053
Time frame: Cycle 1 and Cycle 3 (cycles were 3 weeks)
Elimination Half-life (t1/2) of GEN1053
Time frame: Cycle 1 and Cycle 3 (cycles were 3 weeks)
Area Under the Concentration-time Curve (AUC) From Time Zero to Last Quantifiable Measurement (AUClast) of GEN1053
Time frame: Cycle 1 and Cycle 3 (cycles were 3 weeks)
AUC From Time Zero Over the Dosing Interval (AUCtau) of GEN1053
Time frame: Cycle 1 and Cycle 3 (cycles were 3 weeks)
Number of Participants With Anti-drug Antibodies (ADAs) to GEN1053
Time frame: Cycle 1 Day 1 through end of safety follow up (60 days after last dose [cycles were 3 weeks]), up to approximately 1.5 years
Objective Response Rate (ORR)
Time frame: Up to approximately 1.5 years
Disease Control Rate (DCR)
Time frame: Up to approximately 1.5 years
Duration of Response (DOR)
Time frame: Up to approximately 1.5 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results Summary in Plain LanguageLink provided by the sponsor.
- 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.
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing GEN1053 in people with Solid Tumor, Adult, run by Genmab at 5 sites in 2 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 25 inclusion and 16 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: stopped early, as of the sponsor's last update on 22 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Spain, United States. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Dose Limiting Toxicities (DLTs) (time frame: Day 1 up to Day 21). The study lists 2 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 22 Apr 2025; AzTrials last refreshed its copy on 26 Oct 2026.