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Clinical Studies for the Treatment of Advanced Solid Tumors

NCT06825494 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 194

Last updated 2025-12-18

No results posted yet for this study

Summary

This trial is part of a multicenter, open-label Phase Ib/II clinical study evaluating the efficacy, safety, and tolerability of LM-108 in combination with anti-tumor therapy in patients with advanced solid tumors. Phase Ib of Cohort A1 determines the dose of LM-108 in combination with penpulimab + oxaliplatin + capecitabine. Phase II explores the efficacy and safety of LM-108 in combination with anti-tumor therapy in patients with advanced solid tumors.

Conditions

  • Advanced Solid Tumor

Interventions

DRUG

LM-108 injection+Penpulimab+ Oxaliplatin+Capecitabine

LM-108 injection is a monoclonal antibody that selectively clears regulatory T cells that infiltrate tumor sites. Penpulimab is a novel and differentiated programmed cell death protein 1 (PD-1) monoclonal antibody. Oxaliplatin is a third-generation platinum drug. Capecitabine is a fluoropyrimidine.

DRUG

Tislelizumab+Oxaliplatin+Capecitabine

Tislelizumab is a humanized monoclonal antibody against Programmed cell death -Ligand-1(PD-1). Oxaliplatin is a third-generation platinum drug. Capecitabine is a fluoropyrimidine.

DRUG

LM-108 injection 10mg/kg +penpulimab

LM-108injection is a monoclonal antibody that selectively clears regulatory T cells that infiltrate tumor sites. Penpulimab is a novel and differentiated programmed cell death protein 1 (PD-1) monoclonal antibody.

DRUG

LM-108 injection 600mg + penpulimab

LM-108 injection is a monoclonal antibody that selectively clears regulatory T cells that infiltrate tumor sites. Penpulimab is a novel and differentiated programmed cell death protein 1 (PD-1) monoclonal antibody.

DRUG

enpulimab+ Oxaliplatin+Capecitabine

Penpulimab is a novel and differentiated programmed cell death protein 1 (PD-1) monoclonal antibody. Oxaliplatin is a third-generation platinum drug. Capecitabine is a fluoropyrimidine.

Sponsors & Collaborators

  • Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-08
Primary Completion
2026-03-31
Completion
2026-09-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06825494 on ClinicalTrials.gov