Phase II Study of LM-24C5
ConditionAdvanced Solid Tumor Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorLaNova Medicines Limited
About this trial
This study is to evaluate the efficacy and safety of the LM-24C5 in combination with other therapies in subjects with CEACAM5-positive advanced solid tumor
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Subjects who are willing to participate in the study and sign the informed consent form (ICF) prior to any procedure.
Aged 18-80 years old (including boundary values) , male or female.
Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
Life expectancy ≥ 3 months.
Disqualifiers
Subjects with a history of other malignancies within 5 years prior to first dosing of LM-24C5, excluding cured squamous cell carcinoma of the skin, basal cell carcinoma, non-muscle-invasive bladder cancer, or localized low-risk prostate cancer, carcinoma in situ of the cervix/breast, and other malignancies deemed by the investigator to potentially benefit from participation in this study.
Subjects who have received other anti-tumor treatments before the first dosing of LM-24C5.
Previous immunotherapy and grade ≥3 irAE or grade ≥2 immune-related myocarditis.
Any adverse event from prior anti-tumor therapy has not yet recovered to ≤ grade 1 of CTCAE v5.0.
Trial design
Design model
Sequential
Treatments tested in this trial
LM-24C5
DrugQ2W Administered intravenously Drug: Penpulimab Q2W Administered intravenously Drug: Docetaxel Q3W Administered intravenously
LM-24C5
DrugQ2W Administered intravenously Drug: Penpulimab Q2W Administered intravenously Drug:Trifluridine and Tipiracil Hydrochloride Tablets BID,Oral Administration Drug:Bevacizumab Injection Q2W Administered intravenously
Treatment groups
130 Participants
are divided into 2 treatment groupsGroup A: LM-24C5 in combination with anti-tumor therapiesExperimental treatment 1 intervention
Group B: LM-24C5 in combination with other anti-tumor therapiesExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
ORR
Objective response rate
Time frame
110weeksSecondary outcomes
1
Anti-tumor Activity
Based on RECIST v1.1, evaluated progression-free survival (PFS), duration of response (DOR), disease control rate (DCR = CR + PR + SD), and change in target lesions relative to baseline; overall survival (OS).
Time frame
110weeks2
PK Parameter（AUClast）
Including but not limited to AUClast, AUCtau, Cmax, Tmax, T1/2, Cmax, ss, Cmin, ss, CLss, Vss, Rac, AUC, Rac, Cmax, DF, etc.
Time frame
baseline and 110 weeks3
Immunogenicity of LM-24C5
ADA、Nab
Time frame
baseline and 110 weeks4
Correlation between CEACAM5 and/or PD-L1 expression levels and treatment efficacy.
Correlation between CEACAM5 and/or PD-L1 expression levels and treatment efficacy.
Time frame
baseline and 110 weeksSponsors and contacts
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Source ClinicalTrials.gov