BI-1808 as a Single Agent and With Pembrolizumab (KEYTRUDA® ) in Treatment of Advanced Malignancies(Keynote-D20)

Prior treatment

• Prior treatment-related toxicity not recovered to the level specified in the protocol.
• Prior anticancer therapy, radiotherapy, immunotherapy, investigational treatment, or live vaccine within the protocol-defined washout period.
• History of clinically significant immune-mediated toxicity, including pneumonitis, associated with previous immune-checkpoint inhibitor treatment.
• Major surgery without adequate recovery.
• Prior allogeneic tissue or solid-organ transplantation or active graft-versus-host disease.

Other illness

• Active or clinically significant autoimmune disease, immunodeficiency, or use of prohibited immunosuppressive treatment.
• Uncontrolled or clinically significant cardiovascular disease, serious infection, or another condition that could compromise safety or study participation.
• Known hypersensitivity to a study treatment or its components.
• Another active malignancy, except for protocol-defined permitted malignancies.

Other

• 1\. Active central nervous system metastases or carcinomatous meningitis.
• Pregnancy or breastfeeding, or unwillingness to comply with protocol-defined contraceptive requirements.
• Participation in another interventional clinical trial that conflicts with this study.
• Unable or unlikely to comply with study procedures and requirements.
• For Phase 2a Part C: Receipt of prohibited colony-stimulating factors within the protocol-defined period before treatment.

• Able and willing to provide written informed consent.
• Aged 18 years or older.
• Histologically confirmed advanced or metastatic malignancy eligible for an enrolling study cohort.
• Disease progression following, intolerance of, ineligibility for, or refusal of applicable standard therapy.
• At least one measurable lesion according to the response criteria specified in the protocol.
• Eastern Cooperative Oncology Group performance status of 0 or 1.
• Life expectancy of at least 12 weeks.
• Adequate organ function.
• Willing and medically suitable to provide required tumor or skin biopsies.
• Meets the disease-specific and treatment-history requirements of the applicable Phase 2a cohort.
• For Phase 2a Part C: Histologically confirmed platinum-resistant high-grade serous or clear-cell ovarian carcinoma, prior platinum-based treatment as specified in the protocol, and suitability for paclitaxel treatment.