NCT06821503

Clinical Study Evaluating the Safety, Tolerability, and Preliminary Efficacy of LM-108 ± Penpulimab+Chemotherapy in Advanced Solid Tumors - Cohort C

An Open Label Phase Ib/II Clinical Study Evaluating the Safety, Tolerability, and Preliminary Efficacy of LM-108 ± Penpulimab Plus Chemotherapy in Patients With Advanced Solid Tumors - Cohort C

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 72 (estimated)
• Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This trial is the cohort C part of a multicenter, open label Phase Ib/II clinical study evaluating the preliminary efficacy, safety, and tolerability of LM-108 combined with anti-tumor therapy in patients with advanced solid tumors. The dose of LM-108 combined with penpulimab, albumin paclitaxel, and gemcitabine is recommended in Phase Ib.Explore the efficacy and safety of LM-108 combined with anti-tumor therapy in patients with advanced pancreatic cancer in Phase II.

Conditions

• Advanced Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	LM-108 injection	LM-108 injection is a monoclonal antibody that selectively clears regulatory T cells that infiltrate tumor sites.
DRUG	Penpulimab injection	Penpulimab injection is a Programmed Cell Death Protein 1 (PD-1) immune checkpoint inhibitor.
DRUG	Paclitaxel for injection (albumin bound)	Paclitaxel for injection (albumin bound) is a cytotoxic anticancer drug
DRUG	Gemcitabine hydrochloride for injection	Gemcitabine hydrochloride for injection is a cell cycle specific anti-tumor drug that can inhibit the growth of tumor cells and belongs to a type of chemotherapy drug.

Timeline

• Start date: 2025-04-11
• Primary completion: 2027-12-01
• Completion: 2028-12-01
• First posted: 2025-02-12
• Last updated: 2026-03-10

Locations

16 sites across 1 country: China