Study on INCB177054 for Patients with Advanced or Metastatic Solid Tumors

Inclusion Criteria

• Expected to live for more than 12 weeks.
• In good overall health, with a performance status score of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
• Have a measurable tumor as seen on a CT or MRI scan.
• For certain parts of the study, must have a confirmed diagnosis of a solid tumor that is growing and cannot be cured with surgery or other treatments.
  • For monotherapy: Must have tried all standard treatments available and either not responded, been intolerant, or refused them.
  • For combination therapy: Must have a type of cancer where immunotherapy is suitable.
• For head and neck cancer: Must have a confirmed diagnosis and the cancer must not be treatable with surgery or radiation aimed at curing it. Certain tumor locations are eligible, while others are not.
• For specific groups in the study: Must have certain types of cancer, such as anal cancer, lung cancer with a specific marker, or head and neck cancer with a specific marker.
• Must provide a previous tumor sample or agree to a biopsy before treatment.
• If HIV-positive, must have a stable condition with a specific CD4+ count and undetectable viral load, and be on certain medications.
• Must agree to avoid pregnancy or fathering children during the study.

Exclusion Criteria

• Have another invasive cancer diagnosed within the past year.
• Have active cancer spread to the brain or spinal cord, or worsening of previously treated brain cancer.
• Have previously been treated with a DGK inhibitor.
• Have taken cancer medications or participated in other clinical studies recently.
• Have had an organ transplant.
• Have had radiation therapy recently.
• Have significant side effects from previous treatments.
• Have had severe immune-related side effects from previous immune therapy.
• Have certain abnormal lab results at screening.
• Have uncontrolled medical conditions, such as liver, lung, heart, or autoimmune diseases.
• Have an active infection requiring treatment.
• Have active hepatitis B or C.
• Are taking prohibited medications.
• Are allergic to any part of the study treatment.
• Are pregnant or breastfeeding.
• Have received a live vaccine recently.
• Have any condition that would interfere with participating in the study.