Phase IbII Study of AK129 Combination Therapy for Advanced Solid Tumors Including Non-Small Cell Lung Cancer, Head and Neck Cancer, and Colorectal Cancer

What this Trial Is About

Researchers are evaluating the safety and effectiveness of various combinations including the investigational drug AK129 for treating advanced solid tumors such as non-small cell lung cancer NSCLC, head and neck squamous cell carcinoma HNSCC, colorectal adenocarcinoma CRC, and other advanced tumors. This open, multicenter phase IbII study aims to confirm the recommended dose of AK129 combinations and assess their impact on these cancers. Participants receive different treatment regimens depending on their cancer type and study group. For NSCLC, treatments combine AK129 at different doses with chemotherapy drugs like Pemetrexed, Carboplatin, Paclitaxel, or Docetaxel in 3-week cycles. For HNSCC, AK129 is combined with chemotherapy agents including Carboplatin or Cis-platinum and 5-FU, or with investigator-selected treatments such as Cetuximab or Paclitaxel. Participants with colorectal adenocarcinoma receive AK129 alone until disease progression. Some groups receive Penpulimab plus chemotherapy as an active comparator. During the study, participants are regularly monitored for safety by tracking adverse events and abnormal lab results over about two years. Researchers measure response rates, progression-free survival, overall survival, and other outcomes related to tumor control and treatment duration. Pharmacokinetics and immune responses to the drug are also assessed. Visits occur at regular intervals with ongoing treatment until disease progression or other criteria. The total participation length can be up to approximately two years, with close safety follow-up throughout.

AK129 Combination Therapy for Advanced Solid Tumors