This study is open to adults with advanced small cell lung cancer and other neuroendocrine cancers. The study has 2 parts. The purpose of Part 1 is to find a suitable dose of a combination study treatment, obrixtamig and ZL-1310. The purpose of Part 2 is to see how obrixtamig and ZL-1310 is tolerated when given with another medicine called a checkpoint inhibitor. Another purpose is to check whether the study treatment can stop the cancer from growing and keep it stable. Obrixtamig and ZL-1310 are being developed to help the immune system fight cancer.
In Part 1, participants get obrixtamig and ZL-1310. In Part 2, participants get obrixtamig and ZL-1310 with a checkpoint inhibitor. Part 2 is only open to people with advanced small cell lung cancer. All study treatments are given as infusions into a vein.
The study does not have a fixed duration. Participants can receive study treatment for up to 2 years if they benefit from treatment and can tolerate it. Participants visit the study site regularly, with some overnight stays required. During this time, doctors regularly check for health problems that could be caused by the study treatment. They also monitor the size of the tumour(s) and take laboratory tests.
Small cell lung carcinoma (SCLC)
Large cell neuroendocrine lung carcinoma (LCNEC-L)
Extrapulmonary neuroendocrine carcinoma (epNEC) of small or large cell histology
Patients with tumours with mixed histologies for any above type are eligible only if the neuroendocrine carcinoma/small cell component is predominant and represents at least 50% of the overall tumour tissue
Serious concomitant disease or medical condition such as neurologic, psychiatric (including substance use disorder), active ulcers (gastrointestinal tract or skin) or laboratory abnormalities that may negatively impact patient safety during trial participation, affect compliance with trial requirements or invalidate assessments relevant for the investigation of the safety and preliminary efficacy of the investigational drugs
Patients with a diagnosis of Merkel cell carcinoma or medullary thyroid cancer
Presence of leptomeningeal disease and/or carcinomatous meningitis
Known hypersensitivity to the trial drugs or their excipients, prior severe, life-threatening hypersensitivity reaction(s) to monoclonal antibodies, or significant risk of allergic or anaphylactic reaction(s) to any of the investigated drug products according to the investigator's judgement
Sequential
Obrixtamig
DrugObrixtamig
ZL-1310
DrugZL-1310
Atezolizumab
DrugAtezolizumab
Part 1: The occurrence of dose limiting toxicities (DLTs) during the DLT evaluation period
Part 2: The occurrence of treatment-emergent adverse events (AEs) leading to trial medication discontinuation or dose modification
Part 2: PFS rate at 6 months
Progression-free survival (PFS) is defined as the time from first investigational medicinal product (IMP) administration until the earliest date of disease progression according to Response Evaluation Criteria In Solid Tumours (RECIST 1.1) based on investigator assessments or death from any cause, whichever occurs first.
Part 1 and Part 2: Occurrence of treatment-emergent DLTs
Part 1 and Part 2: Occurrence of treatment-emergent adverse event of special interest (AESIs)
Part 1 and Part 2: Occurrence of treatment-emergent AEs CTCAE Grade ≥3
AEs CTCAE = Adverse events Common Terminology Criteria for Adverse Events
Part 1 and Part 2: Objective response (OR)
OR is defined as a best overall response of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST 1.1 (based on investigator assessments) from the first IMP administration until the earliest date of disease progression, death, last evaluable tumour assessment before the start of the next line of anti-cancer treatment, loss to follow-up, or withdrawal of consent.
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Boehringer Ingelheim
Lead sponsor
Zai Lab
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
