LM-108 injection
DrugLM-108 injection is a monoclonal antibody that selectively clears regulatory T cells that infiltrate tumor sites.
NCT Number: NCT06821503
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 1 / Phase 2
Beijing Cancer Hospital, Beijing, Beijing Municipality, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
LM-108 injection is a monoclonal antibody that selectively clears regulatory T cells that infiltrate tumor sites.
Penpulimab injection is a Programmed Cell Death Protein 1 (PD-1) immune checkpoint inhibitor.
Paclitaxel for injection (albumin bound) is a cytotoxic anticancer drug
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.
Time frame: Baseline up to 28 days
Subjects appear the toxic reaction relate to the drug after treatment within 28 days.
Time frame: Up to 48 weeks
PFS will be defined as median number of months from the date of randomization until the first documented sign of disease progression or death due to any causes, whichever occurs first.
Time frame: Up to 96 weeks
Overall survival defined as the time from enrollment to death from any cause.
Time frame: Up to 48 weeks
DOR will be defined as median number of months from date of first documented objective response until first documented sign of disease progression or death due to any causes.
Time frame: Up to 48 weeks
Objective response rate refers to the percentage of complete response (CR) or partial response (PR) subjects determined by the investigator based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 or modified RECIST 1.1 for immune based therapeutics(iRECIST) (CR and PR under iRECIST criteria can occur after imaging disease progression).
Contact information is provided by the study sponsor or research team.
Jihui Hao, Doctor
CONTACT
Lin Shen, Doctor
CONTACT
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Industry
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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