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New antibody combo shows promise in early cancer trial

NCT ID NCT03917381

Disease control Sponsor: Genmab Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Sep 10, 2026 · Updated 5 times

Summary

This trial tests a new antibody called acasunlimab, alone or with other cancer drugs, in people with advanced solid tumors that have not responded to standard treatments. The study has two parts: first to find safe doses, then to see how well those doses work. About 429 participants will receive the drug; no one gets a placebo.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Acasunlimab (also known as GEN1046), an antibody given alone or with docetaxel or pembrolizumab
What this could lead to
If it works, this could point toward a new treatment option for certain advanced solid tumors that have stopped responding to standard therapy.
What could go wrong
This is an early-phase trial (Phase 1/2) focused on safety and dosing, not yet on effectiveness. The drug may not shrink tumors or may cause side effects. Results may not apply to all cancer types.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

429 people

The number who actually took part.

Started

May 2019

Finished

Aug 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria: 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 * 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 Key Exclusion Criteria: * 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 * 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.

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Conditions

The condition(s) this trial relates to.

cancer cervical cancer endometrial carcinoma head and neck squamous cell carcinoma neoplasm non-small cell lung carcinoma triple-negative breast carcinoma urothelial carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cervical cancer Endometrial carcinoma Non-small cell lung cancer Solid tumors Squamous cell carcinoma of the head and neck Triple-negative breast cancer Urothelial carcinoma

Contacts and locations

Locations

  • ARENSIA Exploratory Medicine LLC

    Kyiv, Ukraine

  • ASST Sette Laghi "Ospedale di Circolo e Fondazione Macchi "

    Varese, Italy

  • AUSL Romagno-Ravenna

    Ravenna, Italy

  • Azienda Ospedaliero Universitaria di Parma

    Parma, Italy

  • BKMK Hospital

    Kecskemét, Hungary

  • Clinica Universidad de Navarra

    Pamplona, 31008, Spain

  • Dom Lekarski SA

    Szczecin, Poland

  • Emory University

    Atlanta, Georgia, 30322, United States

  • Fakultni nemocnice Brno

    Brno, Czechia

  • Fakultni nemocnice Olomouc

    Olomouc, Czechia

  • Gulhane Training and Research Hospital

    Ankara, Turkey (Türkiye)

  • Hadassah Medical Organization HMO - Sharett Institute of Oncology

    Jerusalem, 12000, Israel

  • High Technology Hospital Medcenter

    Batumi, Georgia

  • Hospital Clinico De Valencia

    Valencia, 46010, Spain

  • Hospital Universitario 12 de Octubre

    Madrid, 28041, Spain

  • Hospital Universitario La Princesa

    Madrid, Spain

  • Hospital Universitario Vall dHebron

    Barcelona, 08035, Spain

  • Hospital Universitario Virgen de la Victoria

    Málaga, Spain

  • IOB-Hospital Quironsalud Barcelona

    Barcelona, 8023, Spain

  • IRCCS - Istituto Europeo di Oncologia IEO

    Milan, Italy

  • Istituto Nazionale Tumori - Fondazione Pascale Italy

    Naples, Italy

  • LLC "TIM - Tbilisi Institute of Medicine"

    Tbilisi, Georgia

  • LTD Consilium Medulla

    Tbilisi, Georgia

  • Levine Cancer Institute, Atrium Health

    Charlotte, North Carolina, 28204, United States

  • MD Anderson Cancer Center Madrid

    Madrid, Spain

  • Maria Sklodowska Curie National Research Instutute of Oncology

    Warsaw, Poland

  • Mayo Clinic

    Phoenix, Arizona, 85054, United States

  • Mayo Clinic

    Jacksonville, Florida, 32224, United States

  • Mayo Clinic

    Rochester, Minnesota, 55905, United States

  • Medical Point Izmir Hospital

    Cordaleo, Turkey (Türkiye)

  • Medpolonia Sp. z o.o.

    Poznan, Poland

  • NEXT Oncology Madrid

    Madrid, 28223, Spain

  • NYU Langone

    New York, New York, 10016, United States

  • Nemocnice AGEL Ostrava-Vítkovice a.s.

    Nový Jičín, Czechia

  • Norton Healthcare Inc

    Louisville, Kentucky, 40202, United States

  • Onkologiai Klinika

    Debrecen, Hungary

  • Policlinico San'Orsola

    Bologna, Italy

  • Policlinico Uni. Campus Bio-Medico

    Roma, Italy

  • Pulmonology Hospital Törökbálinti

    Törökbálint, Hungary

  • Rambam Health Care Campus RHCC - Rambam Medical Center

    Haifa, Israel

  • Regina Elena National Cancer Institute

    Rome, Italy

  • START Madrid-CIOCC

    Madrid, 28050, Spain

  • START Madrid-FJD, Hospital Fundación Jiménez Díaz

    Madrid, 28040, Spain

  • START Midwest

    Grand Rapids, Michigan, 49546, United States

  • Sheba Medical Center, Ramat Gan

    Tel Litwinsky, 52621, Israel

  • Specialist Hospital in Prabuty

    Prabuty, Poland

  • Tbilisi State Medical University and Ingorovka High Medical Technology University Clinic Ltd

    Tbilisi, Georgia

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, 64239, Israel

  • Trakya University Hospital

    Edirne, Turkey (Türkiye)

  • UNC Chapel Hill

    Chapel Hill, North Carolina, 27514, United States

  • University Hospital Brno

    Brno, Czechia

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106, United States

  • University of Iowa Hospitals

    Iowa City, Iowa, 52242, United States

  • University of Michigan

    Ann Arbor, Michigan, 48109, United States

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, Poland

  • Washington University School of Medicine

    St Louis, Missouri, 63110, United States

  • Yale University Cancer Center

    New Haven, Connecticut, 06520-8028, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.