A Phase 1 Study Evaluating ZL-1310 Alone and with Atezolizumab and Carboplatin for Safety and Effectiveness in Adults with Small Cell Lung Cancer

What this Trial Is About

Researchers are evaluating ZL-1310 alone and in combination with Atezolizumab, with or without Carboplatin, in people with extensive small cell lung cancer SCLC. This open-label, phase 1 study aims to assess the safety, effectiveness, and how the body processes these treatments. Participants include those with metastatic or extensive-stage SCLC, either previously treated or newly diagnosed depending on the study part. Participants may receive ZL-1310 as a single drug, combined with Atezolizumab, or combined with both Atezolizumab and Carboplatin. The study includes several parts dose escalation to find safe dose levels, dose expansion, and dose extension phases. Some groups receive induction therapy followed by maintenance therapy. The exact dosing and combinations vary by study part and are adjusted based on emerging data. During the study, participants undergo regular assessments including tumor scans CT, PETCT, or MRI, tumor biopsies or tissue sample collection, and monitoring of side effects and treatment responses per RECIST v1.1 criteria. Researchers track safety outcomes such as dose-limiting toxicities and adverse events for up to 24 months, along with measures of tumor control, response rates, and survival. Participants are monitored closely throughout treatment and follow-up periods lasting up to two years.

A Study of ZL-1310 in Subjects With Small Cell Lung Cancer