A Phase Ib/II Study of the Tolerability, Safety, Efficacy, and Pharmacokinetics of ZG006 in Combination With ZG005 in Participants With Advanced Small Cell Lung Cancer or Neuroendocrine Carcinoma(NEC)
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY
This study is a randomized, multicenter, Phase Ib/II clinical trial, aimed at evaluating the efficacy and safety of the combination of ZG006 and ZG005 in patients with advanced small cell lung cancer and neuroendocrine carcinoma.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:
• Fully understand the study and voluntarily sign the informed consent form.
• Male or female 18-70 years of age.
• Participants with advanced small cell lung cancer or neuroendocrine carcinoma confirmed by histopathology or cytology.
• Eastern Cooperative Oncology Group (ECOG) 0 to 1.
• Life expectancy \> 3 months.
Locations
Other Locations
China
Sun Yat-sen University Cancer Center
RECRUITING
Guanzhou
Contact Information
Primary
Hewen Yin
yinhw@zelgen.com
+86-0512-57309965
Time Frame
Start Date: 2025-09-23
Estimated Completion Date: 2027-09
Participants
Target number of participants: 350
Treatments
Experimental: Phase Ib: Part1-Dose Escalation
This study will employ the traditional 3+3 dose escalation design. Ultimately, two combination dosing cohorts will be selected to enter Part 2, the dose expansion phase, based on a comprehensive evaluation of the safety and pharmacokinetic (PK) data obtained by the investigators and the sponsor.
Experimental: Phase Ib: Part2-Dose Expansion
The safety and pharmacokinetic (PK) data obtained in Part 1 will be used to determine two expansion phase doses of the ZG006 and ZG005 combination. The dose expansion study will further evaluate the efficacy of the two selected combination dosing cohorts in patients with advanced small cell lung cancer and neuroendocrine carcinoma.
Experimental: Phase II
Participants will receive the RP2D of ZG006 in combination with ZG005 identified in Phase Ib of the study.
Related Therapeutic Areas
Sponsors
Leads: Suzhou Zelgen Biopharmaceuticals Co.,Ltd