Table of Contents

• Trial overview
• Who can join the studies
• What is being measured
• Trial status and design
• Patient groups and disease settings

Trial overview

The available records describe a Phase 2 interventional study of Al8326 in people with cancer.^[1] The study is focused on small cell lung cancer, non small cell lung cancer, and renal cell carcinoma.^[1]

One record describes the study as a safety and efficacy evaluation in post-first treatment cancer care, while another record focuses on small cell lung cancer only.^{[1][1] The trial uses oral Al8326 at 80 mg as listed in the source data.[1][1]}

Who can join the studies

The studies are for patients who need second-line treatment or later, which means treatment after the first treatment has not been enough or is no longer the best option.^[1][1]

For the small cell lung cancer group, patients may have brain metastasis if it is controlled and there is no active hemorrhage, meaning no ongoing bleeding.^{[1][1] For the non small cell lung cancer group, patients with controlled brain metastasis and no active hemorrhage are included.[1] The renal cell carcinoma group includes patients who need second-line or later treatment.[1]}

What is being measured

The main outcome in the studies is objective response rate, often shortened to ORR.^{[1][1] This means the researchers measure how many patients have their cancer shrink or disappear after treatment.[1][1]}

The studies also measure optimal biological dose, or OBD, which is the dose that seems to give the best balance of benefit and safety in the study setting.^{[1][1] In the first record, OBD and ORR are listed for all dosing groups, and the OBD group is expanded for the small cell lung cancer cohort.[1]}

Trial status and design

One record for NCT05363280 is listed as authorised, and another record with the same NCT number is listed as withdrawn.^{[1][1] Both records describe a Phase 2 interventional design with an enrollment of 130 participants.[1][1]}

The authorised record includes three cancer groups: small cell lung cancer, non small cell lung cancer, and renal cell carcinoma.^[1] The withdrawn record focuses only on small cell lung cancer.^[1]

Patient groups and disease settings

• Small cell lung cancer group: patients need second-line or later treatment, and some may have controlled brain metastasis without active hemorrhage.^[1][1]

• Non small cell lung cancer group: patients need second-line or later treatment and may have controlled brain metastasis without active hemorrhage.^[1]

• Renal cell carcinoma group: patients need second-line or later treatment.^[1]

These groups show that the research is aimed at people with advanced cancer who still need more treatment options after earlier therapy.^[1][1]