NIPH Clinical Trials Search

JRCT ID: jRCT2031210112

Registered date:25/05/2021

Open-label, dose-escalation trial to evaluate the safety and pharmacokinetics of GEN1046 in Japanese subjects with advanced solid malignancies

Basic Information

Recruitment status Not Recruiting
Health condition(s) or Problem(s) studiedSolid tumor
Date of first enrollment06/07/2021
Target sample size18
Countries of recruitment
Study typeInterventional
Intervention(s)Acasunlimab will be administered intravenously once every 21 days. The dose levels will be determined by the starting dose and the escalation steps taken in the trial.


Primary Outcome- Number of Participants with Dose limiting Toxicities (DLTs) - Number of Participants with Adverse Events (AEs) - Area under the concentration time curve (AUC) of acasunlimab - Maximum (Peak) Plasma Concentration (Cmax) of acasunlimab - Time to Reach Cmax (Tmax) of acasunlimab - Plasma Trough (Pre-dose) Concentrations (Cthrough) of acasunlimab - Elimination half-life (t 1/2) of acasunlimab
Secondary OutcomeNumber of Participants with Anti-Drug Antibody (ADA) to acasunlimab

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximumNot applicable
Include criteria- 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. - 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.
Exclude 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-Barre 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 administration. 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.

Related Information


Public contact
Name Inquiry Receipt Center jRCT
Address Keikyu Dai-1 Building 4-10-18 Takanawa, Minato-ku, Tokyo Tokyo Japan 108-0074
Telephone +81-3-6859-9500
Affiliation IQVIA Services Japan G.K
Scientific contact
Name Inquiry Receipt Center jRCT
Address Keikyu Dai-1 Building 4-10-18 Takanawa, Minato-ku, Tokyo Tokyo Japan 108-0074
Telephone +81-3-6859-9500
Affiliation IQVIA Services Japan G.K