RecruitingPhase 1Phase 2NCT06821503

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


Sponsor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Enrollment

72 participants

Start Date

Apr 11, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests an investigational drug called LM-108, used with or without a combination of immunotherapy (penpulimab) and chemotherapy, in people with advanced solid tumors. This is Cohort C of the trial, focusing on safety and early signs of effectiveness. **You may be eligible if...** - You are 18 or older - You have an advanced solid tumor with at least one measurable lesion - Your health performance status is good (ECOG 0-1) - You have adequate organ and blood function - Your expected survival is at least 12 weeks - Side effects from prior treatments have resolved **You may NOT be eligible if...** - You have active brain metastases - You have a serious autoimmune condition - You are pregnant or breastfeeding - You have had recent major surgery or certain prior treatments Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLM-108 injection

LM-108 injection is a monoclonal antibody that selectively clears regulatory T cells that infiltrate tumor sites.

DRUGPenpulimab injection

Penpulimab injection is a Programmed Cell Death Protein 1 (PD-1) immune checkpoint inhibitor.

DRUGPaclitaxel for injection (albumin bound)

Paclitaxel for injection (albumin bound) is a cytotoxic anticancer drug

DRUGGemcitabine 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.


Locations(16)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Cancer Hospital Chinese Academy of Medical Science

Beijing, Beijing Municipality, China

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Chongqing Qeneral Hospital

Chongqing, Chongqing Municipality, China

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Huazhong University of Science and Technology Tongji Medical College of Huazhong University of Science and Technology

Wuhan, Hubei, China

Jiangsu Cancer Hospital

Nanjing, Jiangsu, China

Jiangsu Provincial People's Hospital

Nanjing, Jiangsu, China

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

The First Affiliated Hospital of China Medical University

Shenyang, Liaoning, China

The Sixth People's Hospital of Shenyang

Shenyang, Liaoning, China

The First Affiliated Hospital of Xi'an Jiaotong University Medical College

Xi'an, Shaanxi, China

The First Affiliated Hospital of Naval Medical University

Shanghai, Shanghai Municipality, China

Tianjin Cancer Hospital Airport Hospital

Tianjin, Tianjin Municipality, China

Tianjin Medical University Cancer Institute & Hospital

Tianjin, Tianjin Municipality, China

View Full Details on ClinicalTrials.gov

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NCT06821503


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