Malignant Solid TumorPhase 1/2NCT06391775
Trial to Assess the Safety and Preliminary Efficacy of GEN1055 on Malignant Solid Tumors as Monotherapy and as Combination Therapy
A Phase 1/2 study testing GEN1055, Pembrolizumab and Standard Chemotherapy in people with Malignant Solid Tumor, run by Genmab at 4 sites in 2 countries.
Trial summary
The goal of this trial is to learn about the antibody GEN1055 when it is used alone and when it is used together with another antibody cancer drug, pembrolizumab (with or without chemotherapy), for treatment of participants with certain types of cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Solid Tumor
- What is being tested?
- GEN1055, Pembrolizumab and Standard Chemotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 14 May 2024to 20 Nov 2025
- 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
- All cohorts:
- Be at least 18 years of age.
- Have measurable disease according to RECIST v1.1.
- Provide all pre-baseline scans since failure of last prior therapy (ie, documented radiographic progressive disease [PD]), if available.
- Have Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 to 1 at screening and on C1D1 pretreatment.
- Provide a biopsy (ie, formalin-fixed paraffin-embedded slides/block). A fresh biopsy taken during the screening period is preferred, unless medically unfeasible and after review and approval by the sponsor. If this cannot be provided, a biopsy taken after failure/stop of last prior treatment and taken within 6 months prior to C1D1 may be provided.
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- Phase 1a and 1b- Dose Escalation:
- Have histologically or cytologically confirmed non-Central Nervous System (CNS) primary solid tumors who have metastatic or advanced disease.
- Have progressed on standard of care (SoC) therapy which should include platinum-based chemotherapy and anti-PD/PD-L1 therapies, if applicable for the tumor type, or for whom there is no available standard therapy likely to provide clinical benefit, and for whom experimental therapy with GEN1055 or GEN1055+pembrolizumab may be beneficial, in the opinion of the investigator.
- Phase 2a - Expansion:
- Inclusion criteria specific to selected tumor indications may apply.
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 (including coronavirus disease 2019 [COVID-19] infection).
- Significant cardiovascular impairment including:
- Symptomatic congestive heart failure (Class 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-millimeter (mm) Hg and/or diastolic blood pressure ≥100 mm Hg, despite optimal medical management.
- Prolonged corrected QT interval at baseline of ≥470 milliseconds using Fridericia's QT correction formula.
Show all 21Show fewer
- Ongoing or recent (within 1 year of screening) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk for immune-related adverse events (irAEs).
- History of grade 3 or higher irAEs that led to treatment discontinuation of a checkpoint inhibitor (CPI). A participant with irAEs below grade 3 that led to discontinuation should be discussed with the sponsor. Grade 3 irAEs that have fully recovered may also be discussed.
- History of chronic liver disease (eg, alcoholic hepatitis or nonalcoholic steatohepatitis), drug-related or autoimmune hepatitis, or evidence of hepatic cirrhosis.
- Evidence of interstitial lung disease.
- Ongoing pneumonitis (any grade) including any radiological change of ongoing pneumonitis at baseline or history of noninfectious drug-, immune-, or radiation-related pneumonitis that has required steroids.
- Has been exposed to any of the following prior therapies/treatments within the specified timeframes:
- Treatment with an anticancer agent within 4 weeks or for systemic therapies within 5 half-lives of the drug, whichever is shorter, prior to trial treatment administration.
- 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.
- Has received granulocyte or granulocyte/macrophage colony-stimulating factor support within 2 weeks prior to first trial treatment administration or is chronically transfusion-dependent.
- RT within 14 days before the planned first dose of trial treatment. Palliative RT of bone metastases up to 7 days prior to C1D1 will be allowed.
- Hepatitis (testing for hepatitis B or C is not required unless mandated by local health authority):
- Hepatitis B virus (HBV): Has a medical history or positive serology for HBV (defined as positive for hepatitis B surface antigen or HBV deoxyribonucleic acid [DNA]).
- Above is not exclusionary if deemed due to vaccination, resolved natural infection, or passive immunization due to immunoglobulin therapy.
- Hepatitis C virus (HCV): Known active HCV infection (defined as positive for HCV ribonucleic acid [RNA] [qualitative]).
- Note: Other protocol defined inclusion and exclusion criteria may apply.
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Spain3 sites
Hospital Universtari Val D´Hebron
Barcelona
Start Madrid Ciocc Hm Sanchinarro
Madrid
Clinica Universidad de Navarra
Pamplona, 31008
United States1 site
Yale-New Haven Hospital
New Haven, Connecticut, 06510
About this study
Official title: First-In-Human, Open-Label, Dose Escalation Trial With Expansion Cohorts to Evaluate the Safety and Preliminary Efficacy of GEN1055 as Monotherapy and as Combination Therapy in Subjects With Malignant Solid Tumors
The goal of this trial is to learn about the antibody GEN1055 when it is used alone and when it is used together with another antibody cancer drug, pembrolizumab (with or without chemotherapy), for treatment of participants with certain types of cancer. Participants will receive either GEN1055 alone, GEN1055 with pembrolizumab, or GEN1055 with pembrolizumab and chemotherapy. All participants will receive active drug; no one will receive placebo.
This trial has 2 parts. The purpose of the first part is to find out if GEN1055 is safe and to find out the doses of GEN1055 to use alone and to use with pembrolizumab. The purpose of the second part is to give GEN1055 to more participants to see how well the doses of GEN1055 that were selected in the first part work against cancer alone and how well they work with pembrolizumab (with or without other chemotherapy).
Read more
A participant will receive trial treatment up to a maximum of 24 months for pembrolizumab-containing regimens, or until:
- the cancer progresses.
- there are side effects requiring that treatment be stopped.
- the participant decides to not participate further in this trial.
- the doctor believes it is in the participant's best interest to stop treatment.
Participation in the trial will require visits to the site. For the first 12 weeks there will be weekly visits and after that, visits will be every 3 weeks. At site visits, there will be various tests (such as blood draws) and procedures (such as recording of heart activity, computed tomography (CT) scans) to monitor whether the treatment is safe and effective. The trial duration (including screening, treatment, and follow-up) for each participant will be about 39 months.
Read the detailed description
This is a multi-center trial and will be conducted in two parts: dose escalation (phase 1a/1b) and expansion (phase 2a).
The Dose Escalation part of the trial will evaluate dose-limiting toxicities (DLTs) to determine the recommended phase 2 dose (RP2D), and if reached, the maximum tolerated dose (MTD) in participants with locally advanced or metastatic solid tumors.
The Expansion part will evaluate safety, tolerability, mechanism of action (MoA), immunogenicity, pharmacokinetic (PK), and initial antitumor activity of the selected doses and schedules in selected tumor indications.
- Conditions
- Malignant Solid Tumor
- Being tested
- GEN1055, Pembrolizumab, Standard Chemotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GEN1055Biological
Intravenous (IV) administration.
PembrolizumabBiological
IV administration
Standard ChemotherapyDrug
IV administration
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation | Experimental | GEN1055 will be administered as monotherapy and in combination with a fixed dose of pembrolizumab. Receives: Biological: GEN1055; Biological: Pembrolizumab |
| Expansion | Experimental | GEN1055 will be administered as monotherapy or in combination with pembrolizumab or in combination with pembrolizumab and standard chemotherapy in separate expansion cohorts, at a dose level selected from the Dose Escalation part. Receives: Biological: GEN1055; Biological: Pembrolizumab; Drug: Standard Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Escalation: Number of Participants With Adverse Events (AEs)
An AE was defined as any untoward medical occurrence in a clinical trial participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. 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
Dose Escalation: Number of Participants With Dose Limiting Toxicities (DLTs)
A DLT was defined as any of the following events during the DLT evaluation period (21 days). All grade 5 events, anaphylaxis, grade ≥3 infusion-related reaction (IRR), hematological events (grade 4 neutropenia lasting more than 7 days, grade 4 thrombocytopenia for ≥7 consecutive days, grade 3/4 febrile neutropenia for more than 1 hour, grade 3/4 hemorrhage associated with thrombocytopenia of ≥ grade 3 requiring platelet transfusion, grade 4 anemia), nonhematological events (aspartate aminotransferase [AST] or alanine aminotransferase [ALT] elevations ≥ grade 2 with concomitant bilirubin >2.0×upper limit of normal [ULN] with no signs of cholestasis and no other reason can be found to explain the combination of increased ALT/AST and total bilirubin, ie, a Hy's law case, all nonhematological toxicities of grade ≥3 (severe or life-threatening), with exclusions per protocol). Toxicities were graded for severity according to National Cancer Institute Common Terminology Criteria
Measured: 21 days
Secondary outcomes (12)
Dose Escalation: Maximum (Peak) Plasma Concentration (Cmax) of GEN1055
Blood samples were collected and processed to obtain plasma to evaluate the pharmacokinetics (PK) of GEN1055.
Measured: Cycle 1 and Cycle 2 (cycles were 21 days)
Dose Escalation: Time to Reach Cmax (Tmax) for GEN1055
Blood samples were collected and processed to obtain plasma, to evaluate the PK of GEN1055.
Measured: Cycle 1 and Cycle 2 (cycles were 21 days)
Dose Escalation: Plasma Trough (Pre-dose) Concentrations (Ctrough) of GEN1055
Blood samples were collected and processed to obtain plasma, to evaluate the PK of GEN1055.
Measured: Cycle 1 and Cycle 2 (cycles were 21 days)
Dose Escalation: Area Under the Concentration-Time Curve From Time 0 to Last Quantifiable Sample (AUC0-tlast) for GEN1055
Blood samples were collected and processed to obtain plasma, to evaluate the PK of GEN1055.
Measured: Cycle 1 and Cycle 2 (cycles were 21 days)
Dose Escalation: Area Under the Concentration-Time Curve From Time 0 to Infinity (AUC0-inf) for GEN1055
Blood samples were collected and processed to obtain plasma, to evaluate the PK of GEN1055.
Measured: Cycle 1 and Cycle 2 (cycles were 21 days)
Dose Escalation: Half-life (t½) of GEN1055
Blood samples were collected and processed to obtain plasma, to evaluate the PK of GEN1055.
Measured: Cycle 1 and Cycle 2 (cycles were 21 days)
Dose Escalation: Clearance (CL) of GEN1055 From the Plasma
Blood samples were collected and processed to obtain plasma to evaluate the PK of GEN1055.
Measured: Cycle 1 and Cycle 2 (cycles were 21 days)
Dose Escalation: Number of Participants With Anti-Drug Antibodies (ADA)
Venous blood samples were drawn for analysis of ADAs.
Measured: Up to approximately 1.5 years
Dose Escalation: Overall Response Rate (ORR)
ORR was defined as the number of participants with best overall response (BOR) of complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumours (RECIST) v1.1 as assessed by investigator. CR was defined as disappearance of all target and non-target tumor lesions, 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% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Measured: Up to approximately 1.5 years
Dose Escalation: Duration of Response (DOR)
DOR based on investigator assessment was defined as the time from the first documentation of response (CR or PR) to the date of progressive disease (PD) or death, whichever occurred earlier according to RECIST v1.1. CR was defined as disappearance of all target and non-target tumor lesions, 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. PD was defined as at least 1 of the following:
≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study and an absolute increase of ≥5 mm in the sum of diameters, or unequivocal appearance of 1 or more new lesion(s), or unequivocal progression of non-target lesions.
Measured: Up to approximately 1.5 years
Dose Escalation: Time to Response (TTR)
TTR based on investigator assessment was defined as the time from Cycle 1 Day 1 (C1D1) to first documentation of objective response (CR or PR) in participants achieving PR or CR according to RECIST v1.1. CR was defined as disappearance of all target and non-target tumor lesions, 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.
Measured: Up to approximately 1.5 years
Dose Escalation: Disease Control Rate (DCR)
DCR was defined as the percentage of participants with BOR of CR, PR, or stable disease (SD) according to RECIST v1.1 as assessed by investigator. CR was defined as disappearance of all target and non-target tumor lesions, 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 PD, taking as reference the smallest sum diameters (nadir) while on trial.
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 posted30 Apr 2024
- Study start14 May 2024
- Primary completion20 Nov 2025
- Study completion20 Nov 2025
Why it stopped: Terminated due to strategic decision
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 Malignant Solid TumorStudies 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
- Sequential
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genmab
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- BioNTech SE
- Responsible party
- Sponsor
- Investigators
- Study Official, Study director, Genmab
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06391775
- Sponsor's protocol ID
- GCT1055-01
- Other IDs
- 2023-507049-28-00, 2023
- Status last verified
- Jul 2026
- First submitted
- 25 Apr 2024
- Last updated
- 11 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- 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 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- First-In-Human, Open-Label, Dose Escalation Trial With Expansion Cohorts to Evaluate the Safety and Preliminary Efficacy of GEN1055 as Monotherapy and as Combination Therapy in Subjects With Malignant Solid Tumors
- ClinicalTrials.gov ID
- NCT06391775
- Acronym / sponsor ID
- GCT1055-01
- Conditions
- Malignant Solid Tumor
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated due to strategic decision
- Enrolment
- 21 participants (actual)
- Lead sponsor
- GenmabIndustry (pharma, biotech, devices)
- Collaborators
- BioNTech SE
- Study start
- 14 May 2024 (actual)
- Primary completion
- 20 Nov 2025 (actual)
- Study completion
- 20 Nov 2025 (actual)
- First posted
- 30 Apr 2024 (actual)
- Results
- Posted 11 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this trial is to learn about the antibody GEN1055 when it is used alone and when it is used together with another antibody cancer drug, pembrolizumab (with or without chemotherapy), for treatment of participants with certain types of cancer. Participants will receive either GEN1055 alone, GEN1055 with pembrolizumab, or GEN1055 with pembrolizumab and chemotherapy. All participants will receive active drug; no one will receive placebo.
This trial has 2 parts. The purpose of the first part is to find out if GEN1055 is safe and to find out the doses of GEN1055 to use alone and to use with pembrolizumab. The purpose of the second part is to give GEN1055 to more participants to see how well the doses of GEN1055 that were selected in the first part work against cancer alone and how well they work with pembrolizumab (with or without other chemotherapy).
A participant will receive trial treatment up to a maximum of 24 months for pembrolizumab-containing regimens, or until:
- the cancer progresses.
- there are side effects requiring that treatment be stopped.
- the participant decides to not participate further in this trial.
- the doctor believes it is in the participant's best interest to stop treatment.
Participation in the trial will require visits to the site. For the first 12 weeks there will be weekly visits and after that, visits will be every 3 weeks. At site visits, there will be various tests (such as blood draws) and procedures (such as recording of heart activity, computed tomography (CT) scans) to monitor whether the treatment is safe and effective. The trial duration (including screening, treatment, and follow-up) for each participant will be about 39 months.
Detailed description
This is a multi-center trial and will be conducted in two parts: dose escalation (phase 1a/1b) and expansion (phase 2a).
The Dose Escalation part of the trial will evaluate dose-limiting toxicities (DLTs) to determine the recommended phase 2 dose (RP2D), and if reached, the maximum tolerated dose (MTD) in participants with locally advanced or metastatic solid tumors.
The Expansion part will evaluate safety, tolerability, mechanism of action (MoA), immunogenicity, pharmacokinetic (PK), and initial antitumor activity of the selected doses and schedules in selected tumor indications.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation | Experimental | Biological: GEN1055, Biological: PembrolizumabGEN1055 will be administered as monotherapy and in combination with a fixed dose of pembrolizumab. |
| Expansion | Experimental | Biological: GEN1055, Biological: Pembrolizumab, Drug: Standard ChemotherapyGEN1055 will be administered as monotherapy or in combination with pembrolizumab or in combination with pembrolizumab and standard chemotherapy in separate expansion cohorts, at a dose level selected from the Dose Escalation part. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Be at least 18 years of age.
- Have measurable disease according to RECIST v1.1.
- Provide all pre-baseline scans since failure of last prior therapy (ie, documented radiographic progressive disease [PD]), if available.
- Have Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 to 1 at screening and on C1D1 pretreatment.
- Provide a biopsy (ie, formalin-fixed paraffin-embedded slides/block). A fresh biopsy taken during the screening period is preferred, unless medically unfeasible and after review and approval by the sponsor. If this cannot be provided, a biopsy taken after failure/stop of last prior treatment and taken within 6 months prior to C1D1 may be provided.
Key exclusion criteria (21 listed)
- Has uncontrolled intercurrent illness, including but not limited to:
- Uncontrolled hypertension defined as systolic blood pressure ≥160-millimeter (mm) Hg and/or diastolic blood pressure ≥100 mm Hg, despite optimal medical management.
- Prolonged corrected QT interval at baseline of ≥470 milliseconds using Fridericia's QT correction formula.
- Ongoing or recent (within 1 year of screening) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk for immune-related adverse events (irAEs).
- History of grade 3 or higher irAEs that led to treatment discontinuation of a checkpoint inhibitor (CPI). A participant with irAEs below grade 3 that led to discontinuation should be discussed with the sponsor. Grade 3 irAEs that have fully recovered may also be discussed.
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 |
|---|---|---|
| GEN1055Intravenous (IV) administration. | Biological | Dose Escalation, Expansion |
| PembrolizumabIV administration | Biological | Dose Escalation, Expansion |
| Standard ChemotherapyIV administration | Drug | Expansion |
Primary outcome
Dose Escalation: Number of Participants With Adverse Events (AEs)
Time frame: Up to approximately 1.5 years
An AE was defined as any untoward medical occurrence in a clinical trial participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.
Dose Escalation: Number of Participants With Dose Limiting Toxicities (DLTs)
Time frame: 21 days
A DLT was defined as any of the following events during the DLT evaluation period (21 days). All grade 5 events, anaphylaxis, grade ≥3 infusion-related reaction (IRR), hematological events (grade 4 neutropenia lasting more than 7 days, grade 4 thrombocytopenia for ≥7 consecutive days, grade 3/4 febrile neutropenia for more than 1 hour, grade 3/4 hemorrhage associated with thrombocytopenia of ≥ grade 3 requiring platelet transfusion, grade 4 anemia), nonhematological events (aspartate aminotransferase [AST] or alanine aminotransferase [ALT] elevations ≥ grade 2 with concomitant bilirubin >2.0×upper limit of normal [ULN] with no signs of cholestasis and no other reason can be found to explain the combination of increased ALT/AST and total bilirubin, ie, a Hy's law case, all nonhematological toxicities of grade ≥3 (severe or life-threatening), with exclusions per protocol). Toxicities were graded for severity according to National Cancer Institute Common Terminology Criteria
12 secondary outcomes
Dose Escalation: Maximum (Peak) Plasma Concentration (Cmax) of GEN1055
Time frame: Cycle 1 and Cycle 2 (cycles were 21 days)
Dose Escalation: Time to Reach Cmax (Tmax) for GEN1055
Time frame: Cycle 1 and Cycle 2 (cycles were 21 days)
Dose Escalation: Plasma Trough (Pre-dose) Concentrations (Ctrough) of GEN1055
Time frame: Cycle 1 and Cycle 2 (cycles were 21 days)
Dose Escalation: Area Under the Concentration-Time Curve From Time 0 to Last Quantifiable Sample (AUC0-tlast) for GEN1055
Time frame: Cycle 1 and Cycle 2 (cycles were 21 days)
Dose Escalation: Area Under the Concentration-Time Curve From Time 0 to Infinity (AUC0-inf) for GEN1055
Time frame: Cycle 1 and Cycle 2 (cycles were 21 days)
Dose Escalation: Half-life (t½) of GEN1055
Time frame: Cycle 1 and Cycle 2 (cycles were 21 days)
Dose Escalation: Clearance (CL) of GEN1055 From the Plasma
Time frame: Cycle 1 and Cycle 2 (cycles were 21 days)
Dose Escalation: Number of Participants With Anti-Drug Antibodies (ADA)
Time frame: Up to approximately 1.5 years
Dose Escalation: Overall Response Rate (ORR)
Time frame: Up to approximately 1.5 years
Dose Escalation: Duration of Response (DOR)
Time frame: Up to approximately 1.5 years
Dose Escalation: Time to Response (TTR)
Time frame: Up to approximately 1.5 years
Dose Escalation: Disease Control Rate (DCR)
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 11 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Study Official study director
Genmab
4 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 GEN1055, Pembrolizumab and Standard Chemotherapy in people with Malignant Solid Tumor, run by Genmab at 4 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 11 inclusion and 21 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 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 11 Aug 2026). 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?
Dose Escalation: Number of Participants With Adverse Events (AEs) (time frame: Up to approximately 1.5 years). 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 11 Aug 2026.