In short
Clinical trials are studying Al8326 in patients with small cell lung cancer, non small cell lung cancer, and renal cell carcinoma. These studies look at safety, how well the treatment works, and the best dose for people who need second-line or later treatment. Some trials include patients with controlled brain metastasis.
Key points
- Clinical trials of Al8326 are studying people with small cell lung cancer, non small cell lung cancer, and renal cell carcinoma. The trials are Phase 2 studies, which means they are testing the treatment in patients to learn more about safety and effectiveness. The patient groups include people who need second-line or later treatment. Some trial records also include patients with controlled brain metastasis and no active bleeding. The main outcomes are optimal biological dose and objective response rate. One record is authorised, and another record with the same NCT number is listed as withdrawn.
Trial overview
The available records describe a Phase 2 interventional study of Al8326 in people with cancer. The study is focused on small cell lung cancer, non small cell lung cancer, and renal cell carcinoma.
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. The trial uses oral Al8326 at 80 mg as listed in the source data.
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.
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. For the non small cell lung cancer group, patients with controlled brain metastasis and no active hemorrhage are included. The renal cell carcinoma group includes patients who need second-line or later treatment.
What is being measured
The main outcome in the studies is objective response rate, often shortened to ORR. This means the researchers measure how many patients have their cancer shrink or disappear after treatment.
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. 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.
Trial status and design
One record for NCT05363280 is listed as authorised, and another record with the same NCT number is listed as withdrawn. Both records describe a Phase 2 interventional design with an enrollment of 130 participants.
The authorised record includes three cancer groups: small cell lung cancer, non small cell lung cancer, and renal cell carcinoma. The withdrawn record focuses only on small cell lung cancer.
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.
- Non small cell lung cancer group: patients need second-line or later treatment and may have controlled brain metastasis without active hemorrhage.
- Renal cell carcinoma group: patients need second-line or later treatment.
These groups show that the research is aimed at people with advanced cancer who still need more treatment options after earlier therapy.