Cancer of unknown primary
Conditions
Interventions
AB122 will be administered intravenously on day 1, every 3weeks and TAS-120 will be administered orally once daily
Sponsors
Tanizaki Junko
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients who have provided written informed consent prior to enrollment in the study. 2) Patients with epithelial cancer whose metastatic tumor has been histologically confirmed and whose primary site remains unknown despite enough clinical examination. 3) Patients with cancer of unknown primary site, who have a history of one or more platinum-based chemotherapy and are refractory or intolerant of them. 4) Patients who can provide one or more FFPE tumor tissue blocks or 25 unstained slides. 5) Males and females aged 18 years or older. 6) ECOG PS 0 or 1 7) Patients who are expected to survive for 90 days or more. 8) Patients with measurable lesion as defined by the RECIST version 1.1. 9) Patients who can receive the investigational drug orally. 10) SpO2 94% or higher. 11) Patients with sufficient organ function as determined by clinical laboratory tests. 12) Women of childbearing potential who have tested negative for pregnancy before enrollment.
Exclusion criteria
Exclusion criteria: 1) Patients considered suitable for curative surgery or curative radiation therapy. 2) Patients diagnosed the favorable subset. 3) Patients with a history of severe hypersensitivity reactions to the components of AB122 or TAS-120. 4) Patients whose efficacy and safety evaluations will be affected by toxicity of prior treatment. 5) Patients known to have active CNS metastases and/or carcinomatous meningitis. 6) Patients with autoimmune disease or a history of chronic or recurrent autoimmune disease. 7) Patients who required systemic corticosteroids (equivalent to prednisone exceeding 10 mg/day) or other immunosuppressants within 14 days prior to enrollment. 8) Patients with a history of treatment with anti-PD-(L)1 antibodies or other antibodies or drugs specifically targeting the T-cell costimulation pathway or checkpoint pathway. 9) Patients with a history of FGFR-targeting therapy. 10) Patients with a history or co-existing clinically significant calcium-phosphorus homeostasis abnormalities due to causes other than cancer. 11) Patients with a history of and/or co-existing clinically significant ectopic calcification. 12) Patients with a history or co-existing clinically significant retinal disorders. 13) Patients who have received any of the following treatments - Surgical treatment with general anesthesia local or surface anesthesia. - Radiation therapy - Any anti-cancer treatment. - Administration of other investigational drugs. 14) Specific medical conditions, serious illnesses, or medical conditions. - History or present illness of clinically serious arrhythmias and/or cardiac conduction disorders - History or present illness of gastrointestinal disorder judged to affect the absorption of the investigational drug - Presence of a known acute systemic infection - History of interstitial lung disease/drug-induced interstitial lung disease/radiation pneumonitis/evidence of clinically active interstitial lung disease - Myocardial infarction, severe/unstable angina, or symptomatic congestive heart failure - Stroke or cerebrovascular disease, thrombosis, or thromboembolism - Unmanageable pleural or peritoneal effusion - Pericardial effusion requiring treatment - Presence of a known severe chronic kidney disease - Unmanageable diabetes mellitus, positive for HIV antibodies, HBsAg, or HCV antibodies. - Severe acute or chronic medical or mental condition, abnormal clinical laboratory values, that could affect the study results, and the investigator has determined that participation in this study is inappropriate. 15) Patients with multiple cancers 16) Pregnant or breastfeeding women 17) Pregnant or breastfeeding women or men of childbearing age who do not consent to appropriate contraception 18) Patients who are deemed to lack the capacity to give consent due to conditions such as dementia. 19) Other patients whom the principal investigator has determined to be unsuitable for inclusion in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate by independent review | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate by investigator's judgement, Disease control rate, Overall survival, Progression-free survival, Duration of response, Time to response, Percent change from baseline in target lesion, and Safety Correlation between efficacy and PD-L1 status, lymph node metastasis patterns | — |
Contacts
Public ContactMitsuru Shimomura
West Japan Oncology Group
Outcome results
None listed