Solid TumorsPhase 1/2NCT03917381
GEN1046 Safety Trial in Patients With Malignant Solid Tumors
A Phase 1/2 study testing Acasunlimab, Acasunlimab in combination with docetaxel (in a single expansion cohort) and Acasunlimab in combination with pembrolizumab (in a separate expansion cohort) in people with Solid Tumors, run by Genmab at 57 sites in 10 countries.
Trial summary
The goal of this trial is to learn about the antibody acasunlimab (an antibody also known as GEN1046) when it is used alone and when it is used together with standard of care treatment (docetaxel) or another antibody cancer drug, pembrolizumab (with or without chemotherapy), for treatment of patients with certain… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumors
- What is being tested?
- Acasunlimab, Acasunlimab in combination with docetaxel (in a single expansion cohort) and Acasunlimab in combination with pembrolizumab (in a separate expansion cohort)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 429 participants
- Where
- 57 sitesin 10 countries
- Study dates
- 14 May 2019to 3 Aug 2026
- 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 Dose Escalation:
- Have a histologically or cytologically confirmed non-CNS solid tumor that is metastatic or unresectable and for whom there is no available standard therapy
- For Expansion:
- Have histologically or cytological confirmed diagnosis of relapsed or refractory, advanced and/or metastatic NSCLC, EC, UC, TNBC, SCCHN, or cervical cancer who are not anymore candidates for standard therapy For separate expansion cohorts: metastatic NSCLC without prior systemic treatment regimens for metastatic disease.
- For Both Dose Escalation and Expansion
- Have measurable disease according to RECIST 1.1
Show all 11Show fewer
- Have Eastern Cooperative Oncology Group (ECOG) 0-1
- Have an acceptable hematological status
- Have acceptable liver function
- Have an acceptable coagulation status
- Have acceptable renal function
Who cannot join
- Have uncontrolled intercurrent illness, including but not limited to:
- Ongoing or active infection requiring intravenous treatment with anti-infective therapy, or any ongoing systemic inflammatory condition requiring further diagnostic work-up or management during screening.
- 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 mmHg and/or diastolic blood pressure ≥ 100 mmHg, despite optimal medical management
- Ongoing or recent evidence of autoimmune disease
- History of irAEs that led to prior checkpoint treatment discontinuation
Show all 17Show fewer
- Prior history of myositis, Guillain-Barré syndrome, or myasthenia gravis of any grade
- History of chronic liver disease or evidence of hepatic cirrhosis
- History of non-infectious pneumonitis that has required steroids or currently has pneumonitis
- History of organ allograft (except for corneal transplant) or autologous or allogeneic bone marrow transplant, or stem cell rescue within 3 months prior to the first dose of acasunlimab
- Serious, non-healing wound, skin ulcer (of any grade), or bone fracture
- Any history of intracerebral arteriovenous malformation, cerebral aneurysm, new (younger than 6 months) or progressive brain metastases or stroke
- Prior therapy:
- Radiotherapy within 14 days prior to first dose of acasunlimab. Note: 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 acasunlimab administration. Accepted exceptions are bisphosphonates (e.g., pamidronate, zoledronic acid, etc.) and denosumab
- Toxicities from previous anti-cancer therapies that have not adequately resolved
- NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
57 sites in 10 countries.
57 sites in 10 countries
United States14 sites
University of Michigan
Ann Arbor, Michigan, 48109
Emory University
Atlanta, Georgia, 30322
UNC Chapel Hill
Chapel Hill, North Carolina, 27514
Levine Cancer Institute, Atrium Health
Charlotte, North Carolina, 28204
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
START Midwest
Grand Rapids, Michigan, 49546
University of Iowa Hospitals
Iowa City, Iowa, 52242
Mayo Clinic
Jacksonville, Florida, 32224
Norton Healthcare Inc
Louisville, Kentucky, 40202
Yale University Cancer Center
New Haven, Connecticut, 06520-8028
NYU Langone
New York, New York, 10016
Mayo Clinic
Phoenix, Arizona, 85054
Mayo Clinic
Rochester, Minnesota, 55905
Washington University School of Medicine
St Louis, Missouri, 63110
Spain11 sites
Hospital Universitario Vall dHebron
Barcelona, 08035
IOB-Hospital Quironsalud Barcelona
Barcelona, 8023
START Madrid-FJD, Hospital Fundación Jiménez Díaz
Madrid, 28040
Hospital Universitario 12 de Octubre
Madrid, 28041
START Madrid-CIOCC
Madrid, 28050
NEXT Oncology Madrid
Madrid, 28223
Hospital Universitario La Princesa
Madrid
MD Anderson Cancer Center Madrid
Madrid
Hospital Universitario Virgen de la Victoria
Málaga
Clinica Universidad de Navarra
Pamplona, 31008
Hospital Clinico De Valencia
Valencia, 46010
Italy8 sites
Policlinico San'Orsola
Bologna
IRCCS - Istituto Europeo di Oncologia IEO
Milan
Istituto Nazionale Tumori - Fondazione Pascale Italy
Naples
Azienda Ospedaliero Universitaria di Parma
Parma
AUSL Romagno-Ravenna
Ravenna
Policlinico Uni. Campus Bio-Medico
Roma
Regina Elena National Cancer Institute
Rome
ASST Sette Laghi "Ospedale di Circolo e Fondazione Macchi "
Varese
Poland5 sites
Uniwersyteckie Centrum Kliniczne
Gdansk
Medpolonia Sp. z o.o.
Poznan
Specialist Hospital in Prabuty
Prabuty
Dom Lekarski SA
Szczecin
Maria Sklodowska Curie National Research Instutute of Oncology
Warsaw
Czechia4 sites
Fakultni nemocnice Brno
Brno
University Hospital Brno
Brno
Nemocnice AGEL Ostrava-Vítkovice a.s.
Nový Jičín
Fakultni nemocnice Olomouc
Olomouc
Georgia4 sites
High Technology Hospital Medcenter
Batumi
LLC "TIM - Tbilisi Institute of Medicine"
Tbilisi
LTD Consilium Medulla
Tbilisi
Tbilisi State Medical University and Ingorovka High Medical Technology University Clinic Ltd
Tbilisi
Israel4 sites
Rambam Health Care Campus RHCC - Rambam Medical Center
Haifa
Hadassah Medical Organization HMO - Sharett Institute of Oncology
Jerusalem, 12000
Tel Aviv Sourasky Medical Center
Tel Aviv, 64239
Sheba Medical Center, Ramat Gan
Tel HaShomer, 52621
Hungary3 sites
Onkologiai Klinika
Debrecen
BKMK Hospital
Kecskemét
Pulmonology Hospital Törökbálinti
Törökbálint
Turkey (Türkiye)3 sites
Gulhane Training and Research Hospital
Ankara
Medical Point Izmir Hospital
Cordaleo
Trakya University Hospital
Edirne
About this study
Official title: First-in-human, Open-label, Dose-escalation Trial With Expansion Cohorts to Evaluate Safety of GEN1046 in Subjects With Malignant Solid Tumors
The goal of this trial is to learn about the antibody acasunlimab (an antibody also known as GEN1046) when it is used alone and when it is used together with standard of care treatment (docetaxel) or another antibody cancer drug, pembrolizumab (with or without chemotherapy), for treatment of patients with certain types of cancer. All subjects 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 acasunlimab at various doses is safe and to find out the best doses of acasunlimab to use. The purpose of the second part is to give acasunlimab to more subjects to see how well the doses of acasunlimab selected in the first part work against cancer when given alone and how well they work when given with pembrolizumab with or without chemotherapy.
Read more
Trial details include:
- The average trial duration for an individual subject will be about 74 weeks.
- The average treatment duration for an individual subject will be about 21 weeks.
- The visit frequency will be weekly at first and lessening over time until visits are only once every 3 weeks.
Read the detailed description
The trial is an open-label, multi-center safety trial of acasunlimab (GEN1046). The trial consists of 2 consecutive parts: a first-in-human (FIH) dose escalation (phase 1) and an expansion (phase 2a). The expansion part of the trial will be initiated once the Recommended Phase 2 Dose (RP2D) has been determined.
- Conditions
- Solid Tumors
- Being tested
- Acasunlimab, Acasunlimab in combination with docetaxel (in a single expansion cohort), Acasunlimab in combination with pembrolizumab (in a separate expansion cohort), Acasunlimab in combination with pembrolizumab and standard chemotherapy (in separate expansion cohorts)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcasunlimabBiological
Also called GEN1046, DuoBody®-PD-L1x4-1BB
Acasunlimab will be administered intravenously once every 21 days (in selected expansion cohorts acasunlimab will be administered intravenously once every 21 days for the first 2 cycles, and every 42 days in subsequent cycles).
Acasunlimab in combination with docetaxel (in a single expansion cohort)Biological
Also called GEN1046, DuoBody®-PD-L1x4-1BB
Acasunlimab and docetaxel will be administered intravenously once every 21 days.
Acasunlimab in combination with pembrolizumab (in a separate expansion cohort)Biological
Also called GEN1046, DuoBody®-PD-L1x4-1BB
Acasunlimab and pembrolizumab will be administered intravenously once every 21 days or every 42 days, respectively.
Acasunlimab in combination with pembrolizumab and standard chemotherapy (in separate expansion cohorts)Biological
Also called GEN1046, DuoBody®-PD-L1x4-1BB
Acasunlimab and pembrolizumab and standard chemotherapy will be administered intravenously once every 21 days for 4 cycles, followed by treatment with acasunlimab and pembrolizumab once every 21 days.
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation | Experimental | Acasunlimab will be administered as monotherapy. Receives: Biological: Acasunlimab |
| Expansion | Experimental | Acasunlimab will be administered as monotherapy or in combination with either docetaxel, pembrolizumab, or pembrolizumab + standard chemotherapy in separate expansion cohorts. Receives: Biological: Acasunlimab; Biological: Acasunlimab in combination with docetaxel (in a single expansion cohort); Biological: Acasunlimab in combination with pembrolizumab (in a separate expansion cohort); Biological: Acasunlimab in combination with pembrolizumab and standard chemotherapy (in separate expansion cohorts) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Escalation: Number of Participants With Dose Limiting Toxicities (DLT)
In this trial, a DLT was defined as any grade 5 toxicity, grade 4 neutropenia lasting more than 7 days, grade 3 and 4 febrile neutropenia, grade 4 thrombocytopenia for minimal duration of 7 days, grade 3\&4 hemorrhage associated with thrombocytopenia of ≥ grade 3 requiring platelet transfusion, grade 4 anemia, liver toxicity (transaminases and bilirubin elevations), grade 3 nausea that didn't respond to optimal antiemetic treatment within 7 days, grade ≥3 vomiting that didn't respond to optimal antiemetic treatment within 3 days, grade ≥3 diarrhea that didn't respond to optimal antidiarrheal treatment within 3 days, grade 3 immune-related adverse event (irAEs) that didn't improve to ≤ grade 1 within 7 days by appropriate care or with corticosteroids (with exceptions per protocol), any grade 4 irAE, any other ≥ grade 3 non-hematological adverse events (AE), which occurred during the first GEN1046 treatment cycle (with exceptions per protocol).
Measured: During first cycle (21 days)
Dose Escalation and Monotherapy Expansion Cohorts: Number of Participants With Treatment-emergent 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 was therefore 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. Treatment-emergent AEs were any AEs that developed or worsened after the first dose 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 5 years, 10 months
Expansion Cohort 1: Objective Response Rate (ORR)
ORR was defined as the percentage of participants with best overall response (BOR) of complete response (CR) or partial response (PR) based on response evaluation criteria in solid tumors (RECIST v1.1). CR was defined as disappearance of all target lesions. Any pathological lymph nodes must have had a reduction in short axis to <10 millimeters (mm). PR was defined as ≥30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum of LDs.
Measured: Up to approximately 5 years, 10 months
Secondary outcomes (9)
Combination Therapy Expansion Cohorts: Number of Participants With Treatment-emergent 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 was therefore 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. Treatment-emergent AEs were any AEs that developed or worsened after the first dose 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 5 years, 10 months
Dose Escalation: Area Under the Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUClast) of GEN1046
Venous blood samples were collected for measurement of plasma concentrations of GEN1046. Data reported are average values for Cycle 1 and Cycle 2.
Measured: Cycle 1 and Cycle 2 (cycles were 21 days)
Dose Escalation: Maximum Observed Plasma Concentration (Cmax) of GEN1046
Venous blood samples were collected for measurement of plasma concentrations of GEN1046. Data reported are average values for Cycle 1 and Cycle 2.
Measured: Cycle 1 and Cycle 2 (cycles were 21 days)
Number of Participants With Anti-drug Antibodies (ADAs) to GEN1046
Venous blood samples were collected for measurement of serum concentrations of ADAs. A participant was considered as positive overall status if: (i) negative at baseline and at least one positive post-baseline result; or (ii) positive at baseline and at least one positive post-baseline result with a titer higher than baseline.
Measured: Up to approximately 5 years, 10 months
Dose Escalation and Expansion Cohorts 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13: ORR
ORR was defined as the percentage of participants with BOR of CR or PR based on RECIST. CR was defined as disappearance of all target lesions. Any pathological lymph nodes must have had a reduction in short axis to <10 mm. PR was defined as ≥30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum of LDs.
Measured: Up to approximately 5 years, 10 months
Dose Escalation and Expansion Cohorts 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13: Disease Control Rate (DCR)
DCR was defined as the percentage of participants with confirmed BOR of CR, PR, or stable disease (SD) according to RECIST v1.1. CR was defined as disappearance of all target lesions. Any pathological lymph nodes must have had a reduction in short axis to <10 mm. PR was defined as ≥30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum of LDs. 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 of LDs while in trial. Follow-up measurements must have met the SD criteria at least once and for a minimum time period of 6 weeks (±7 days) after first treatment.
Measured: Up to approximately 5 years, 10 months
Duration of Response (DoR)
DOR was defined as the time from first documentation of response (CR or PR) to the date of the first documented progression or death whichever occurred earlier based on RECIST v1.1. DOR only applied to participants whose confirmed best overall response was CR or PR (i.e., responders).
Measured: Up to approximately 5 years, 10 months
Expansion Cohort 1: Progression Free Survival (PFS)
PFS was defined as the time from Day 1 in Cycle 1 (cycles were 21 days) to the first documented progression or death due to any cause, whichever occurred first based on RECIST version 1.1.
Measured: Up to approximately 5 years, 10 months
Expansion Cohort 1: Overall Survival (OS)
OS was defined as the time from Day 1 in Cycle 1 (cycles were 21 days) to death due to any cause.
Measured: Up to approximately 5 years, 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2019
- Study start14 May 2019
- Primary completion1 Apr 2025
- Study completion3 Aug 2026
Why it stopped: Genmab has decided to discontinue further clinical development of acasunlimab following strategic portfolio prioritization. The decision was not related to safety concerns.
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Solid TumorsStudies 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
- 429 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genmab
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Official, Study director, Genmab
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03917381
- Sponsor's protocol ID
- GCT1046-01
- Other IDs
- 2018-003402-63, MOH_2019-05-08_006011, 2023-509059-15, 2023, 2018
- Status last verified
- Aug 2026
- First submitted
- 11 Apr 2019
- Last updated
- 9 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Muik A, Garralda E, Altintas I, Gieseke F, Geva R, Ben-Ami E, Maurice-Dror C, Calvo E, LoRusso PM, Alonso G, Rodriguez-Ruiz ME, Schoedel KB, Blum JM, Sanger B, Salcedo TW, Burm SM, Stanganello E, Verzijl D, Vascotto F, Sette A, Quinkhardt J, Plantinga TS, Toker A, van den Brink EN, Fereshteh M, Diken M, Satijn D, Kreiter S, Breij ECW, Bajaj G, Lagkadinou E, Sasser K, Tureci O, Forssmann U, Ahmadi T, Sahin U, Jure-Kunkel M, Melero I. Preclinical Characterization and Phase I Trial Results of a Bispecific Antibody Targeting PD-L1 and 4-1BB (GEN1046) in Patients with Advanced Refractory Solid Tumors. Cancer Discov. 2022 May 2;12(5):1248-1265. doi: 10.1158/2159-8290.CD-21-1345.
PubMed 35176764
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 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 Safety of GEN1046 in Subjects With Malignant Solid Tumors
- ClinicalTrials.gov ID
- NCT03917381
- Acronym / sponsor ID
- GCT1046-01
- Conditions
- Solid Tumors
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Genmab has decided to discontinue further clinical development of acasunlimab following strategic portfolio prioritization. The decision was not related to safety concerns.
- Enrolment
- 429 participants (actual)
- Lead sponsor
- GenmabIndustry (pharma, biotech, devices)
- Study start
- 14 May 2019 (actual)
- Primary completion
- 1 Apr 2025 (actual)
- Study completion
- 3 Aug 2026 (actual)
- First posted
- 17 Apr 2019 (actual)
- Results
- Posted 4 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 acasunlimab (an antibody also known as GEN1046) when it is used alone and when it is used together with standard of care treatment (docetaxel) or another antibody cancer drug, pembrolizumab (with or without chemotherapy), for treatment of patients with certain types of cancer. All subjects 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 acasunlimab at various doses is safe and to find out the best doses of acasunlimab to use. The purpose of the second part is to give acasunlimab to more subjects to see how well the doses of acasunlimab selected in the first part work against cancer when given alone and how well they work when given with pembrolizumab with or without chemotherapy.
Trial details include:
- The average trial duration for an individual subject will be about 74 weeks.
- The average treatment duration for an individual subject will be about 21 weeks.
- The visit frequency will be weekly at first and lessening over time until visits are only once every 3 weeks.
Detailed description
The trial is an open-label, multi-center safety trial of acasunlimab (GEN1046). The trial consists of 2 consecutive parts: a first-in-human (FIH) dose escalation (phase 1) and an expansion (phase 2a). The expansion part of the trial will be initiated once the Recommended Phase 2 Dose (RP2D) has been determined.
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: AcasunlimabAcasunlimab will be administered as monotherapy. |
| Expansion | Experimental | Biological: Acasunlimab, Biological: Acasunlimab in combination with docetaxel (in a single expansion cohort), Biological: Acasunlimab in combination with pembrolizumab (in a separate expansion cohort), Biological: Acasunlimab in combination with pembrolizumab and standard chemotherapy (in separate expansion cohorts)Acasunlimab will be administered as monotherapy or in combination with either docetaxel, pembrolizumab, or pembrolizumab + standard chemotherapy in separate expansion cohorts. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Have a histologically or cytologically confirmed non-CNS solid tumor that is metastatic or unresectable and for whom there is no available standard therapy
- Have histologically or cytological confirmed diagnosis of relapsed or refractory, advanced and/or metastatic NSCLC, EC, UC, TNBC, SCCHN, or cervical cancer who are not anymore candidates for standard therapy For separate expansion cohorts: metastatic NSCLC without prior systemic treatment regimens for metastatic disease.
- For Both Dose Escalation and Expansion
- Have measurable disease according to RECIST 1.1
- Have Eastern Cooperative Oncology Group (ECOG) 0-1
Key exclusion criteria (17 listed)
- Have uncontrolled intercurrent illness, including but not limited to:
- Any history of intracerebral arteriovenous malformation, cerebral aneurysm, new (younger than 6 months) or progressive brain metastases or stroke
- Prior therapy:
- Toxicities from previous anti-cancer therapies that have not adequately resolved
- 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 |
|---|---|---|
| AcasunlimabAlso: GEN1046, DuoBody®-PD-L1x4-1BBAcasunlimab will be administered intravenously once every 21 days (in selected expansion cohorts acasunlimab will be administered intravenously once every 21 days for the first 2 cycles, and every 42 days in subsequent cycles). | Biological | Dose Escalation, Expansion |
| Acasunlimab in combination with docetaxel (in a single expansion cohort)Also: GEN1046, DuoBody®-PD-L1x4-1BBAcasunlimab and docetaxel will be administered intravenously once every 21 days. | Biological | Expansion |
| Acasunlimab in combination with pembrolizumab (in a separate expansion cohort)Also: GEN1046, DuoBody®-PD-L1x4-1BBAcasunlimab and pembrolizumab will be administered intravenously once every 21 days or every 42 days, respectively. | Biological | Expansion |
| Acasunlimab in combination with pembrolizumab and standard chemotherapy (in separate expansion cohorts)Also: GEN1046, DuoBody®-PD-L1x4-1BBAcasunlimab and pembrolizumab and standard chemotherapy will be administered intravenously once every 21 days for 4 cycles, followed by treatment with acasunlimab and pembrolizumab once every 21 days. | Biological | Expansion |
Primary outcome
Dose Escalation: Number of Participants With Dose Limiting Toxicities (DLT)
Time frame: During first cycle (21 days)
In this trial, a DLT was defined as any grade 5 toxicity, grade 4 neutropenia lasting more than 7 days, grade 3 and 4 febrile neutropenia, grade 4 thrombocytopenia for minimal duration of 7 days, grade 3\&4 hemorrhage associated with thrombocytopenia of ≥ grade 3 requiring platelet transfusion, grade 4 anemia, liver toxicity (transaminases and bilirubin elevations), grade 3 nausea that didn't respond to optimal antiemetic treatment within 7 days, grade ≥3 vomiting that didn't respond to optimal antiemetic treatment within 3 days, grade ≥3 diarrhea that didn't respond to optimal antidiarrheal treatment within 3 days, grade 3 immune-related adverse event (irAEs) that didn't improve to ≤ grade 1 within 7 days by appropriate care or with corticosteroids (with exceptions per protocol), any grade 4 irAE, any other ≥ grade 3 non-hematological adverse events (AE), which occurred during the first GEN1046 treatment cycle (with exceptions per protocol).
Dose Escalation and Monotherapy Expansion Cohorts: Number of Participants With Treatment-emergent Adverse Events (AEs)
Time frame: Up to approximately 5 years, 10 months
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 was therefore 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. Treatment-emergent AEs were any AEs that developed or worsened after the first dose 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.
Expansion Cohort 1: Objective Response Rate (ORR)
Time frame: Up to approximately 5 years, 10 months
ORR was defined as the percentage of participants with best overall response (BOR) of complete response (CR) or partial response (PR) based on response evaluation criteria in solid tumors (RECIST v1.1). CR was defined as disappearance of all target lesions. Any pathological lymph nodes must have had a reduction in short axis to <10 millimeters (mm). PR was defined as ≥30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum of LDs.
9 secondary outcomes
Combination Therapy Expansion Cohorts: Number of Participants With Treatment-emergent AEs
Time frame: Up to approximately 5 years, 10 months
Dose Escalation: Area Under the Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUClast) of GEN1046
Time frame: Cycle 1 and Cycle 2 (cycles were 21 days)
Dose Escalation: Maximum Observed Plasma Concentration (Cmax) of GEN1046
Time frame: Cycle 1 and Cycle 2 (cycles were 21 days)
Number of Participants With Anti-drug Antibodies (ADAs) to GEN1046
Time frame: Up to approximately 5 years, 10 months
Dose Escalation and Expansion Cohorts 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13: ORR
Time frame: Up to approximately 5 years, 10 months
Dose Escalation and Expansion Cohorts 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13: Disease Control Rate (DCR)
Time frame: Up to approximately 5 years, 10 months
Duration of Response (DoR)
Time frame: Up to approximately 5 years, 10 months
Expansion Cohort 1: Progression Free Survival (PFS)
Time frame: Up to approximately 5 years, 10 months
Expansion Cohort 1: Overall Survival (OS)
Time frame: Up to approximately 5 years, 10 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35176764Muik A, Garralda E, Altintas I, Gieseke F, Geva R, Ben-Ami E, Maurice-Dror C, Calvo E, LoRusso PM, Alonso G, Rodriguez-Ruiz ME, Schoedel KB, Blum JM, Sanger B, Salcedo TW, Burm SM, Stanganello E, Verzijl D, Vascotto F, Sette A, Quinkhardt J, Plantinga TS, Toker A, van den Brink EN, Fereshteh M, Diken M, Satijn D, Kreiter S, Breij ECW, Bajaj G, Lagkadinou E, Sasser K, Tureci O, Forssmann U, Ahmadi T, Sahin U, Jure-Kunkel M, Melero I. Preclinical Characterization and Phase I Trial Results of a Bispecific Antibody Targeting PD-L1 and 4-1BB (GEN1046) in Patients with Advanced Refractory Solid Tumors. Cancer Discov. 2022 May 2;12(5):1248-1265. doi: 10.1158/2159-8290.CD-21-1345.
- 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
57 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Acasunlimab, Acasunlimab in combination with docetaxel (in a single expansion cohort) and Acasunlimab in combination with pembrolizumab (in a separate expansion cohort) in people with Solid Tumors, run by Genmab at 57 sites in 10 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 17 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 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 57 sites in United States, Spain, Italy, Poland, Czechia and 5 more countries. 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 4 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 Dose Limiting Toxicities (DLT) (time frame: During first cycle (21 days)). 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?
On the ClinicalTrials.gov record for NCT03917381, which also lists 1 linked publication.
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 9 Sep 2026.