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Solid TumorPhase 1NCT04937153

GEN1046 Safety and PK in Subjects With Advanced Solid Malignancies

A Phase 1 study testing Acasunlimab and Pembrolizumab in people with Solid Tumor, run by Genmab at 2 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The primary objective of the study is to evaluate the safety, tolerability, dose-limiting toxicity (DLT) and pharmacokinetics (PK) of acasunlimab (also known as GEN1046) administered as monotherapy or in combination with pembrolizumab in Japanese study participants with malignant solid tumors. Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Solid Tumor
What is being tested?
Acasunlimab and Pembrolizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
2 sitesJapan
Study dates
15 Jun 2021to 1 Oct 2024
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 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participant must have a histologically-confirmed non-central nervous system (CNS) solid tumor that is metastatic or unresectable and for whom there is no available standard therapy likely to confer clinical benefit; or a participant who is not a candidate for such available therapy and for whom, in the opinion of the investigator, experimental therapy with acasunlimab or acasunlimab in combination with pembrolizumab may be beneficial.
  • Asian race and Japanese ethnicity.
  • Have measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
  • Have Eastern Cooperative Oncology Group (ECOG) 0-1.
  • Have an acceptable hematological status.
  • Have acceptable liver function.
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  • Have an acceptable coagulation status.
  • Have acceptable renal function.
  • Should provide a tumor tissue sample (formalin-fixed paraffin-embedded [FFPE] blocks/slides) from archival tissue or fresh biopsy collected before C1D1, preferably derived from advanced disease stage.

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.
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  • Prior history of myositis, Guillain-Barré syndrome, or myasthenia gravis of any grade.
  • History of chronic liver disease or evidence of hepatic cirrhosis.
  • Evidence of interstitial lung disease.
  • 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 trial treatment.
  • 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: Radiotherapy within 14 days prior to the first dose of trial treatment. 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 trial treatment administration.
  • Toxicities from previous anti-cancer therapies that have not adequately resolved.
  • Note: Other protocol specified inclusion/exclusion criteria may apply.

Trial locations and contacts

2 sites in 1 country.

Japan2 sites

  • National Cancer Center East

    Chiba

  • National Cancer Center Hospital

    Tokyo

Other trials in Japan

About this study

Official title: Open-label, Dose-escalation Trial to Evaluate the Safety and Pharmacokinetics of GEN1046 in Japanese Subjects With Advanced Solid Malignancies

The primary objective of the study is to evaluate the safety, tolerability, dose-limiting toxicity (DLT) and pharmacokinetics (PK) of acasunlimab (also known as GEN1046) administered as monotherapy or in combination with pembrolizumab in Japanese study participants with malignant solid tumors.

Conditions
Solid Tumor
Being tested
Acasunlimab, Pembrolizumab

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 (IV) once every 21 days.

  • PembrolizumabBiological

    Pembrolizumab will be administered IV once every 21 days.

Study groups in NCT04937153
Study groupRoleWhat they receive
acasunlimab monotherapyExperimentalNot described
Receives: Biological: Acasunlimab
acasunlimab + pembrolizumab combination therapyExperimentalNot described
Receives: Biological: Acasunlimab; Biological: Pembrolizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants with Dose limiting Toxicities (DLTs)

    Determine the DLT profile of acasunlimab administered as monotherapy or in combination with pembrolizumab. The DLTs will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) criteria version 5.0.

    Measured: During first cycle (Cycle length=21 days) in each cohort

  2. Number of Participants with Adverse Events (AEs)

    An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.

    Measured: From first dose date up to end of the safety follow up period, 90 days after last dose

  3. Area under the concentration time curve (AUC) of Acasunlimab

    Measured: Predose and postdose at multiple timepoints of each cycle (Cycle length=21 days)

  4. Maximum (Peak) Plasma Concentration (Cmax) of Acasunlimab

    Measured: Predose and postdose at multiple timepoints of each cycle (Cycle length=21 days)

  5. Time to Reach Cmax (Tmax) of Acasunlimab

    Measured: Predose and postdose at multiple timepoints of each cycle (Cycle length=21 days)

  6. Plasma Trough (Pre-dose) Concentrations (Cthrough) of Acasunlimab

    Measured: Predose and postdose at multiple timepoints of each cycle (Cycle length=21 days)

  7. Elimination half-life (t 1/2) of Acasunlimab

    Measured: Predose and postdose at multiple timepoints of each cycle (Cycle length=21 days)

Secondary outcomes (1)

  1. Number of Participants with Anti-Drug Antibody (ADA) to Acasunlimab

    Serum samples will be screened for ADAs to acasunlimab and the titer of confirmed positive samples will be reported.

    Measured: Up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jun 2021
  2. Study start15 Jun 2021
  3. Primary completion1 Oct 2024
  4. Study completion1 Oct 2024

Resources

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
Non-randomised
Intervention model
Sequential
Model description
The starting dose is 15 mg administered as a flat dose. Dose escalation steps are based on safety data.
Masking
None (open label)
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04937153
Sponsor's protocol ID
GCT1046-02
Other IDs
jRCT2031210112
Status last verified
Jul 2025
First submitted
11 May 2021
Last updated
16 Jul 2025
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Acasunlimab and Pembrolizumab in people with Solid Tumor, run by Genmab at 2 sites in Japan.

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 9 inclusion and 18 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 16 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Japan. 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?

Number of Participants with Dose limiting Toxicities (DLTs) (time frame: During first cycle (Cycle length=21 days) in each cohort). The study lists 7 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 NCT04937153.

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 16 Jul 2025.

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