Open-label, dose-escalation trial to evaluate the safety and pharmacokinetics of GEN1046 in Japanese subjects with advanced solid malignancies
- Conditions
- Solid tumor
- Registration Number
- JPRN-jRCT2031210112
- Lead Sponsor
- jRCT Inquiry Receipt Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 39
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.
* Have uncontrolled intercurrent illness, including but not limited to:
- Ongoing or active infection requiring intravenous treatment with anti-infective therapy.
- 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method - Number of Participants with Dose limiting Toxicities (DLTs)<br>- Number of Participants with Adverse Events (AEs)<br>- Area under the concentration time curve (AUC) of acasunlimab<br>- Maximum (Peak) Plasma Concentration (Cmax) of acasunlimab<br>- Time to Reach Cmax (Tmax) of acasunlimab<br>- Plasma Trough (Pre-dose) Concentrations (Cthrough) of acasunlimab<br>- Elimination half-life (t 1/2) of acasunlimab
- Secondary Outcome Measures
Name Time Method umber of Participants with Anti-Drug Antibody (ADA) to acasunlimab