Yükleniyor... / Loading...
Dose Escalation Study of a PD1-LAG3 Bispecific Antibody in Patients With Advanced and/or Metastatic Solid Tumors
Bu çalışma, ileri ve/veya metastatik solid tümörü (solid tumors) olan hastalarda PD1-LAG3 bispesifik antikoru olan RO7247669 ilacının farklı dozlarını değerlendirmektedir. Çalışmaya, standart tedavilerin işe yaramadığı veya uygun olmadığı, histolojik olarak doğrulanmış ileri kanseri olan hastalar (melanom, akciğer kanseri, yemek borusu kanseri gibi) alınmıştır. Çalışma Faz 1/Faz 2 aşamasındadır; şu an katılımcı almamakta ancak devam etmektedir (active, not recruiting).
Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.
Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.
Inclusion criteria * Patient must have histologically or cytologically confirmed advanced and/or metastatic solid tumor malignancies for which standard curative or palliative measures do not exist, are no longer effective, or are not acceptable to the patient * Eastern Cooperative Oncology Group Performance Status 0-1 * Fresh biopsies may be required * Women of childbearing potential and male participants must agree to remain abstinent or use contraceptive methods as defined by the protocol Additional Specific Inclusion Criteria for Participants with Melanoma * Histologically confirmed, unresectable stage III or stage IV melanoma * Not more than 2 prior lines of treatment for metastatic disease are allowed prior to enrolling in the study * Prior treatment with an approved anti-PD-1 or anti-PD-L1 agent Additional Specific Inclusion Criteria for Participants with Non-Small Cell Lung Cancer who Previously Received Treatment for Metastatic Disease * Participants with histologically confirmed advanced non-small cell lung cancer * Not more than 2 prior lines of treatment for metastatic disease are allowed prior to enrolling in the study * Previously treated with approved PD-L1/PD-1 inhibitors * Tumor PD-L1 expression as determined by immunohistochemistry assay of archival tumor tissue or tissue obtained at screening Additional Specific Inclusion Criteria for Participants with Esophageal Squamous Cell Carcinoma * Participants whose major lesion was histologically confirmed as squamous cell carcinoma or adenosquamous cell carcinoma of the esophagus * Participants who have previously received not more than 1 prior line of treatment for metastatic disease prior to enrolling in the study Additional Specific Inclusion Criteria for Participants with Non-Small Cell Lung Cancer who Previously did not Receive Treatment for Metastatic Disease * Participants with histologically confirmed advanced non-small cell lung cancer * Tumor PD-L1 expression as determined by immunohistochemistry assay of archival tumor tissue or tissue obtained at screening Exclusion criteria * Pregnancy, lactation, or breastfeeding * Known hypersensitivity to any of the components of RO7247669 * Active or untreated central nervous system (CNS) metastases * An active second malignancy * Evidence of concomitant diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the participant at high risk from treatment complications * Positive HIV, hepatitis B, or hepatitis C test result * Known active or uncontrolled bacterial, viral, fungal, mycobacterial, parasitic, or other infection * Vaccination with live vaccines within 28 days prior to Cycle 1 Day 1 * Treatment with oral or IV antibiotics within 2 weeks prior to Cycle 1 Day 1 * Active or history of autoimmune disease or immune deficiency * Prior treatment with adoptive cell therapies, such as CAR-T therapies * Concurrent therapy with any other investigational drug \< 28 days or 5 half-lives of the drug, whichever is shorter, prior to the first RO7247669 administration * Regular immunosuppressive therapy * Radiotherapy within the last 4 weeks before start of study drug treatment, with the exception of limited palliative radiotherapy * Prior treatment with a lymphocyte activation gene-3 (LAG-3) inhibitor Additional Specific Exclusion Criteria for Participants with Non-Small Cell Lung Cancer who Previously Received Treatment for Metastatic Disease * Participants with the following muations, rearrangements, translocations are not eligible: EGFR, ALK, ROS1, BRAFV600E, and NTRK Additional Specific Exclusion Criteria for Participants with Esophageal Squamous Cell Carcinoma * Prior therapy with any immunomodulatory agents Additional Specific Exclusion Criteria for Participants with Non-Small Cell Lung Cancer who Previously did not Receive Treatment for Metastatic Disease * Prior therapy for metastatic disease is not permitted * Neo-adjuvant anti-PD-1 or anti-PD-L1 therapy is not allowed