In short
ZL-1310 is an investigational protein-based substance with no marketing authorisation, supplied by Zai Lab (Shanghai) Co. Ltd. It is given by intravenous infusion and is being studied in two authorised clinical trials for small cell lung cancer and related neuroendocrine cancers. One trial is a Phase 3 study comparing ZL-1310 with investigator-chosen therapy in 480 people with relapsed small cell lung cancer.
ZL-1310 is an investigational protein-based substance supplied by Zai Lab (Shanghai) Co. Ltd. It has no marketing authorisation in the product records, which means it is not yet approved as a medicine. The substance is given as an intravenous infusion. It is currently being studied in two authorised clinical trials for small cell lung cancer and related neuroendocrine cancers.
Key points
- ZL-1310 is an investigational protein-based substance given by intravenous infusion.
- It is being tested in a Phase 3 trial with 480 participants who have relapsed small cell lung cancer.
- The Phase 3 trial compares ZL-1310 with topotecan or other therapies chosen by the investigator.
- A separate Phase 1 trial studies ZL-1310 in combination with obrixtamig in 54 people with neuroendocrine cancers.
- The main measures in the Phase 3 trial are objective response rate and overall survival.
- Both trials are currently authorised, meaning they may begin or are preparing to enrol participants.
What is ZL-1310?
ZL-1310 is a protein-based substance, meaning it is made from proteins rather than being a small chemical molecule. It is an investigational medicine: the product records show no marketing authorisation, so it cannot yet be prescribed outside of clinical trials. The substance is supplied by Zai Lab (Shanghai) Co. Ltd. and appears in the registry under the name ZL-1310. In the two trials listed here, ZL-1310 is the substance being tested.
How does ZL-1310 work?
The available registry records do not describe the exact mechanism of action of ZL-1310. What is known from the trial data is that ZL-1310 is a protein-based substance given intravenously, and that it is being studied for its anti-tumour activity in small cell lung cancer. The Phase 3 trial is designed to compare the anti-tumour activity of ZL-1310 with therapies selected by the investigator, and to compare ZL-1310 with investigator-chosen therapy in prolonging overall survival.
Which conditions is ZL-1310 used or studied for?
- Small cell lung cancer (SCLC) — a fast-growing type of lung cancer. The Phase 3 trial studies ZL-1310 in people whose SCLC has relapsed, meaning the cancer has returned after previous treatment.
- Large cell neuroendocrine lung carcinoma — a rare type of lung cancer with neuroendocrine features. It is included in the Phase 1 combination trial.
- Extrapulmonary neuroendocrine carcinoma — neuroendocrine cancers that arise outside the lung, including both small cell and large cell histology. These are also studied in the Phase 1 trial.
How is ZL-1310 given?
ZL-1310 is given as an intravenous infusion. In the Phase 3 trial, the dose of ZL-1310 reported in the registry is 1.60 mg per kilogram of body weight, given intravenously. In the Phase 1 trial, ZL-1310 is also given by intravenous use, but the dose is not specified in the registry record.
What do the clinical trials show?
ZL-1310 is being studied in two authorised clinical trials. Both are interventional studies, meaning participants receive the treatment and are then followed over time. The trials are at different stages of research.
Which phases and what status do the trials have?
One trial is a Phase 3 study, the most advanced phase before a medicine can be considered for approval. It is authorised and plans to enrol 480 participants with relapsed small cell lung cancer. The other is a Phase 1 study, the earliest phase of testing in humans. It is authorised and plans to enrol 54 participants with advanced small cell lung cancer or other neuroendocrine cancers.
What are the trials measuring?
The Phase 3 trial has two primary measures. The first is the confirmed objective response rate (ORR), which means the proportion of participants whose tumours shrink by a defined amount, assessed by an independent central review using standard criteria called RECIST v1.1. The second is overall survival (OS), which measures how long participants live.
The Phase 1 trial measures different things. In Part 1, the main measure is the occurrence of dose-limiting toxicities (DLTs), which are side effects severe enough to prevent increasing the dose. In Part 2, the main measures are treatment-emergent adverse events leading to discontinuation or dose modification, and progression-free survival (PFS) rate at 6 months, which means the proportion of participants alive without their cancer worsening six months after starting treatment.
Who can take part in these trials?
The Phase 3 trial is for people with relapsed small cell lung cancer. Participants receive either ZL-1310 or a therapy selected by the investigator, which may include topotecan given either orally or intravenously. The Phase 1 trial is for people with advanced small cell lung cancer or other neuroendocrine cancers, including large cell neuroendocrine lung carcinoma and extrapulmonary neuroendocrine carcinoma. In this trial, ZL-1310 is studied in combination with obrixtamig, with or without atezolizumab.
What side effects are known?
The registry records for these two trials do not list specific side effects for ZL-1310. The Phase 1 trial is specifically designed to characterise the safety and tolerability of the combination of obrixtamig and ZL-1310, so safety information is being collected during the study. At this stage, no side effect data are available from the provided sources.