New antibody combo tackles solid tumors in early trial
NCT ID NCT06391775
First seen Jun 27, 2026 · Last updated Aug 12, 2026 · Updated 2 times
Summary
This early-phase trial tested a new antibody drug, GEN1055, in 21 adults with advanced solid tumors. The goal was to check safety and find the right dose when used alone or with pembrolizumab (with or without chemotherapy). The study was stopped early, but results help guide future research.
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
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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21 people
The number who actually took part.
- Started
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May 2024
- Finished
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Nov 2025
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
Inclusion Criteria: 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. 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. Exclusion Criteria: * 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: i) Symptomatic congestive heart failure (Class III or IV as classified by the New York Heart Association), unstable angina pectoris, or cardiac arrhythmia. ii) Uncontrolled hypertension defined as systolic blood pressure ≥160-millimeter (mm) Hg and/or diastolic blood pressure ≥100 mm Hg, despite optimal medical management. iii) 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. * 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 \[DNA\]). i) 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Clinica Universidad de Navarra
Pamplona, 31008, Spain
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Hospital Universtari Val D´Hebron
Barcelona, Spain
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Start Madrid Ciocc Hm Sanchinarro
Madrid, Spain
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Yale-New Haven Hospital
New Haven, Connecticut, 06510, United States
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